Atherosclerotic Cardiovascular DiseasePhase 3NCT01663402
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
A Phase 3 study testing Alirocumab and LMT in people with Atherosclerotic Cardiovascular Disease, run by Sanofi at 1,388 sites in 57 countries.
Trial summary
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Alirocumab and LMT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,924 participants
- Where
- 1,388 sitesin 57 countries
- Study dates
- Oct 2012to 23 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently (< 52 weeks) hospitalized for ACS.
Who cannot join
- Age < 40 years.
- ACS event occurring more than 52 weeks prior to randomization visit.
- LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
1,388 sites in 57 countries.
1388 sites in 57 countries
United States273 sites
Investigational Site Number 840364
Akron, Ohio, 44304
Investigational Site Number 840254
Alexandria, Louisiana, 71301
Investigational Site Number 840133
Allentown, Pennsylvania, 18102
Investigational Site Number 840347
Altamonte Springs, Florida, 32714
Investigational Site Number 840205
Amarillo, Texas, 79106
Investigational Site Number 840352
Amarillo, Texas, 79106
Investigational Site Number 840154
Ames, Iowa, 50010
Investigational Site Number 840118
Anderson, South Carolina, 29621
Investigational Site Number 840351
Annapolis, Maryland, 21401
Investigational Site Number 840237
Arlington Heights, Illinois, 60005
Investigational Site Number 840075
Atlanta, Georgia
Investigational Site Number 840332
Atlantis, Arizona, 33462
Investigational Site Number 840142
Auburn, Maine, 04210
Investigational Site Number 840148
Auburn, Maine
Investigational Site Number 840176
Augusta, Georgia, 30901
Investigational Site Number 840096
Aurora, Colorado, 80012
Investigational Site Number 840135
Austin, Texas, 78756
Investigational Site Number 840097
Bangor, Maine, 04401
Investigational Site Number 840139
Banning, California
Investigational Site Number 840104
Beaver, Pennsylvania, 15009
Investigational Site Number 840025
Bellevue, Washington, 98004
Investigational Site Number 840072
Beltsville, Maryland
Investigational Site Number 840193
Bethesda, Maryland, 20817
Investigational Site Number 840286
Beverly Hills, California, 90210
Investigational Site Number 840246
Beverly Hills, California, 90211
Investigational Site Number 840353
Beverly Hills, California, 90211
Investigational Site Number 840163
Birmingham, Alabama, 35235
Investigational Site Number 840060
Birmingham, Alabama, 35294
Investigational Site Number 840056
Boston, Massachusetts, 02111
Investigational Site Number 840122
Bridgeport, Connecticut, 06606
Investigational Site Number 840077
Bridgewater, New Jersey, 08807
Investigational Site Number 840173
Bridgewater, New Jersey
Investigational Site Number 840322
Buffalo, New York, 14215
Investigational Site Number 840053
Burlington, Vermont, 05401
Investigational Site Number 840262
Burlington, Wisconsin, 53105
Investigational Site Number 840170
Camp Hill, Pennsylvania, 17011
Investigational Site Number 840341
Carmichael, California, 95608
Investigational Site Number 840049
Charlottesville, Virginia, 22908-0679
Investigational Site Number 840260
Charlottesville, Virginia
Investigational Site Number 840285
Chattanooga, Tennessee, 37421
Investigational Site Number 840292
Chicago, Illinois, 60612
Investigational Site Number 840299
Chula Vista, California, 91910
Investigational Site Number 840131
Cincinnati, Ohio
Investigational Site Number 840066
Clearwater, Florida, 33756
Investigational Site Number 840037
Colorado Springs, Colorado, 80909
Investigational Site Number 840200
Columbia, Maryland, 21044
Investigational Site Number 840046
Columbia, Missouri, 65201
Investigational Site Number 840045
Columbus, Ohio, 43210
Investigational Site Number 840265
Columbus, Ohio, 43210
Investigational Site Number 840048
Covington, Georgia, 30014
Investigational Site Number 840065
Cumming, Georgia, 30041
Investigational Site Number 840301
Dallas, Texas, 75226
Investigational Site Number 840152
Dallas, Texas, 75231
Investigational Site Number 840157
Dallas, Texas, 75390
Investigational Site Number 840079
Daytona Beach, Florida, 32114
Investigational Site Number 840051
Daytona Beach, Florida, 32117
Investigational Site Number 840368
Delray Beach, Florida, 33484
Investigational Site Number 840189
Denver, Colorado, 80220
Investigational Site Number 840020
Doylestown, Pennsylvania, 18901
Investigational Site Number 840199
Duluth, Minnesota, 55805
Investigational Site Number 840116
Edina, Minnesota, 55435
Investigational Site Number 840070
Elizabeth City, North Carolina, 27909
Investigational Site Number 840358
Elkhart, Indiana, 46514
Investigational Site Number 840016
Erie, Pennsylvania, 16502-4604
Investigational Site Number 840321
Everett, Washington, 98201
Investigational Site Number 840214
Fargo, North Dakota
Investigational Site Number 840127
Flemington, New Jersey, 08822
Investigational Site Number 840144
Flint, Michigan, 48532
Investigational Site Number 840242
Fort Lauderdale, Florida, 33308
Investigational Site Number 840229
Fort Worth, Texas, 76104
Investigational Site Number 840120
Fort Worth, Texas, 76107
Investigational Site Number 840258
Fort Worth, Texas
Investigational Site Number 840234
Framingham, Maine, 01702
Investigational Site Number 840164
Fresno, California, 93721
Investigational Site Number 840076
Fullerton, California, 92835
Investigational Site Number 840134
Gainesville, Florida, 32608
Investigational Site Number 840306
Glasston, North Dakota, 21229
Investigational Site Number 840329
Goodyear, Pennsylvania, 85395
Investigational Site Number 840033
Grand Island, Nebraska, 68803
Investigational Site Number 840365
Grandville, Michigan, 49418
Investigational Site Number 840298
Green Bay, Wisconsin, 54303
Investigational Site Number 840059
Green Bay, Wisconsin
Investigational Site Number 840303
Greenville, North Carolina, 27834
Investigational Site Number 840182
Greenville, North Carolina
Investigational Site Number 840190
Greenwood, South Carolina
Investigational Site Number 840219
Guilford, Connecticut, 06437
Investigational Site Number 840359
Hackensack, New Jersey, 07601
Investigational Site Number 840036
Hammond, Indiana, 46320
Investigational Site Number 840350
Harrisonburg, Virginia, 22801
Investigational Site Number 840146
Harvey, Illinois, 60426
Investigational Site Number 840327
Hollywood, Florida, 33021
Investigational Site Number 840153
Hudson, Florida, 34667
Investigational Site Number 840105
Hudson, Florida
Investigational Site Number 840073
Huntington Beach, California, 92648
Investigational Site Number 840117
Huntsville, Alabama, 35801
Investigational Site Number 840192
Huntsville, Alabama, 35801
Investigational Site Number 840211
Idaho Falls, Idaho, 83404
Investigational Site Number 840180
Independence, Missouri, 64057
Investigational Site Number 840026
Indianapolis, Indiana
Investigational Site Number 840345
Iowa City, Iowa
Investigational Site Number 840287
Jackson, Tennessee, 38301
Investigational Site Number 840253
Jacksonville, Florida, 32204
Investigational Site Number 840141
Jacksonville, Florida, 32209
Investigational Site Number 840042
Jacksonville, Florida, 32216
Investigational Site Number 840206
Jacksonville, Florida, 32216
Investigational Site Number 840063
Jacksonville, Florida, 32258
Investigational Site Number 840040
Johnson City, Tennessee, 37604
Investigational Site Number 840340
Joliet, Illinois, 60435
Investigational Site Number 840002
Jupiter, Florida, 33458
Investigational Site Number 840093
Kalamazoo, Michigan
Investigational Site Number 840032
Kalispell, Montana, 59901
Investigational Site Number 840335
Kansas City, Kansas, 64116
Investigational Site Number 840089
Kansas City, Kansas, 66160-7321
Investigational Site Number 840218
Kansas City, Kansas
Investigational Site Number 840136
Kingwood, Texas, 77339
Investigational Site Number 840126
Knoxville, Pennsylvania
Investigational Site Number 840238
Knoxville, Tennessee, 37917-4524
Investigational Site Number 840177
La Crosse, Wisconsin, 54601
Investigational Site Number 840092
La Jolla, California, 92093
Investigational Site Number 840344
Lafayette, Louisiana, 70503
Investigational Site Number 840187
Lake Charles, Louisiana, 70601
Investigational Site Number 840249
Lancaster, Pennsylvania, 17603
Investigational Site Number 840150
Lancaster, Pennsylvania
Investigational Site Number 840360
Lancaster, South Carolina, 29720
Investigational Site Number 840198
Lansing, Michigan, 48910
Investigational Site Number 840119
Largo, Florida
Investigational Site Number 840221
Las Vegas, Nevada, 89146
Investigational Site Number 840215
Leesburg, Virginia
Investigational Site Number 840030
Lexington, Kentucky
Investigational Site Number 840208
Long Beach, California, 90801
Investigational Site Number 840068
Long Beach, California, 90822
Investigational Site Number 840113
Lorain, Ohio, 44053
Investigational Site Number 840115
Lorain, Ohio, 44053
Investigational Site Number 840269
Los Alamitos, California, 90720
Investigational Site Number 840009
Los Angeles, California, 90073
Investigational Site Number 840282
Los Angeles, California, 90095
Investigational Site Number 840023
Louisville, Kentucky, 40205
Investigational Site Number 840007
Louisville, Kentucky, 40207
Investigational Site Number 840027
Lubbock, Texas, 79410
Investigational Site Number 840202
Lufkin, Texas, 75904
Investigational Site Number 840010
Lynchburg, Virginia, 24501
Investigational Site Number 840225
Manassas, Virginia, 20109
Investigational Site Number 840300
Manitowoc, Wisconsin, 54220
Investigational Site Number 840013
Marquette, Missouri
Investigational Site Number 840309
Maumee, Ohio, 43537
Investigational Site Number 840241
Miami Beach, Florida, 33140
Investigational Site Number 840291
Minden, Louisiana, 71055
Investigational Site Number 840281
Minneapolis, Minnesota, 55407
Investigational Site Number 840095
Minot, North Dakota, 58701
Investigational Site Number 840019
Mission Viejo, California, 92691
Investigational Site Number 840121
Mobile, Alabama, 36604
Investigational Site Number 840319
Mobile, Alabama, 36695
Investigational Site Number 840348
Moorestown, New Jersey, 08057
Investigational Site Number 840336
Moreno Valley, California, 92553
Investigational Site Number 840210
Mount Clemens, Florida
Investigational Site Number 840257
Mountain Lakes, North Dakota
Investigational Site Number 840102
Muncie, Indiana, 47303-3400
Investigational Site Number 840314
Myrtle Beach, South Carolina, 29572
Investigational Site Number 840062
Nashua, New Hampshire, 03060
Investigational Site Number 840128
New Brunswick, New Jersey, 08903-0019
Investigational Site Number 840278
New Orleans, Louisiana, 70112
Investigational Site Number 840366
New Port Richey, Florida, 34653
Investigational Site Number 840248
New York, New York, 10016
Investigational Site Number 840371
New York, New York
Investigational Site Number 840333
Newburgh, New York, 47630
Investigational Site Number 840320
Newport Beach, Arizona, 92663
Investigational Site Number 840124
Northridge, California, 91325
Investigational Site Number 840195
Oak Ridge, Tennessee, 37830
Investigational Site Number 840270
Odessa, Texas, 79761
Investigational Site Number 840334
Oklahoma City, Oklahoma, 73104
Investigational Site Number 840337
Oklahoma City, Oklahoma, 73120
Investigational Site Number 840015
Omaha, Nebraska, 68122
Investigational Site Number 840021
Omaha, Nebraska, 68122
Investigational Site Number 840001
Omaha, Nebraska
Investigational Site Number 840256
Orem, Utah, 84058
Investigational Site Number 840179
Overland, Missouri
Investigational Site Number 840140
Overland Park, Kansas, 66209
Investigational Site Number 840279
Owensboro, Kentucky, 42303
Investigational Site Number 840311
Palm Beach Gardens, Florida, 33410
Investigational Site Number 840280
Palm Harbor, Florida, 34684
Investigational Site Number 840054
Panama City, Florida, 32401
Investigational Site Number 840251
Pasadena, California, 91105
Investigational Site Number 840289
Pasadena, California, 91105
Investigational Site Number 840129
Pawtucket, Rhode Island, 02860
Investigational Site Number 840239
Pembroke Pines, Florida, 33024
Investigational Site Number 840044
Pensacola, Florida, 32501
Investigational Site Number 840196
Peoria, Illinois, 61614
Investigational Site Number 840231
Philadelphia, Pennsylvania, 19085
Investigational Site Number 840339
Philadelphia, Pennsylvania, 19104
Investigational Site Number 840308
Pikeville, Kentucky, 41501
Investigational Site Number 840230
Pittsburgh, Pennsylvania, 15240
Investigational Site Number 840367
Plantation, Florida, 33317
Investigational Site Number 840167
Pomona, New Jersey, 08240
Investigational Site Number 840312
Port Hueneme, California, 93041
Investigational Site Number 840184
Portland, Oregon, 97239
Investigational Site Number 840017
Poughkeepsie, New York, 12601
Investigational Site Number 840243
Raleigh, North Carolina, 27610
Investigational Site Number 840342
Raleigh, North Carolina, 27610
Investigational Site Number 840008
Rapid City, South Dakota, 57701
Investigational Site Number 840022
Richmond, Virginia, 23225
Investigational Site Number 840078
Richmond, Virginia, 23249
Investigational Site Number 840110
Richmond, Virginia, 23298
Investigational Site Number 840067
Ridgewood, New Jersey, 07506
Investigational Site Number 840149
Roanoke, Virginia, 24014
Investigational Site Number 840087
Rochester Hills, Michigan, 48085
Investigational Site Number 840081
Rock Island, Illinois, 61201
Investigational Site Number 840090
Rock Island, Illinois, 61201
Investigational Site Number 840349
Rockville, Maryland, 20850
Investigational Site Number 840293
Rocky Mount, North Carolina, 27804
Investigational Site Number 840132
Safety Harbor, Florida, 34695
Investigational Site Number 840061
Safety Harbor, Florida
Investigational Site Number 840094
Saint Cloud, Minnesota, 56303
Investigational Site Number 840181
Saint Paul, Kentucky, 55102
Investigational Site Number 840324
Saint Paul, Minnesota, 55101
Investigational Site Number 840296
Salt Lake City, Utah, 84124
Investigational Site Number 840162
San Antonio, Texas, 78229
Investigational Site Number 840232
San Antonio, Texas, 78229
Investigational Site Number 840261
San Diego, California, 92120
Investigational Site Number 840310
San Diego, California, 92120
Investigational Site Number 840024
San Diego, California
Investigational Site Number 840071
Santa Ana, California, 92704
Investigational Site Number 840236
Santa Rosa, California, 95405
Investigational Site Number 840247
Sarasota, Florida, 34239
Investigational Site Number 840028
Sayre, Pennsylvania, 18840
Investigational Site Number 840276
Scarborough, Maine, 04074
Investigational Site Number 840328
Schertz, Texas, 78154
Investigational Site Number 840069
Scranton, Pennsylvania, 18503
Investigational Site Number 840316
Scranton, Pennsylvania, 18510
Investigational Site Number 840273
Seven Fields, Pennsylvania, 16046
Investigational Site Number 840290
Shreveport, Louisiana, 71103
Investigational Site Number 840250
Somerset, New Jersey, 08873
Investigational Site Number 840145
South Bend, Indiana, 46601-1075
Investigational Site Number 840326
Spokane, Washington, 99204
Investigational Site Number 840004
Springfield, Michigan, 65807
Investigational Site Number 840267
Springfield, Michigan
Investigational Site Number 840297
Springfield, Ohio, 45505
Investigational Site Number 840228
St Louis, Missouri, 63128
Investigational Site Number 840233
St Louis, Missouri, 63128
Investigational Site Number 840235
St Louis, Missouri, 63128
Investigational Site Number 840175
St Louis, Missouri, 63136
Investigational Site Number 840125
St Louis, Missouri, 63141
Investigational Site Number 840168
St Louis, Missouri
Investigational Site Number 840088
Statesville, North Carolina, 28627
Investigational Site Number 840086
Tacoma, Washington, 98415-0299
Investigational Site Number 840264
Tampa, Florida, 33606
Investigational Site Number 840082
Tampa, Florida, 33613
Investigational Site Number 840222
The Bronx, New York, 10467
Investigational Site Number 840356
Thomasville, Georgia, 31792
Investigational Site Number 840274
Thomure, Missouri
Investigational Site Number 840172
Toledo, Ohio, 43623
Investigational Site Number 840012
Torrance, California
Investigational Site Number 840213
Trinity, Florida, 34655
Investigational Site Number 840114
Tucker, Georgia, 30084
Investigational Site Number 840103
Tucson, Arizona, 85724
Investigational Site Number 840084
Tucson, Arizona
Investigational Site Number 840018
Tulsa, Oklahoma, 74104
Investigational Site Number 840158
Tyler, Texas, 75701
Investigational Site Number 840166
Valhalla, New York, 10595
Investigational Site Number 840318
Victoria, Texas, 77901
Investigational Site Number 840277
Voorhees Township, New Jersey, 08043
Investigational Site Number 840295
Walla Walla, Washington, 99362
Investigational Site Number 840227
Washington, Pennsylvania
Investigational Site Number 840165
Wellington, Florida, 33449
Investigational Site Number 840283
West Des Moines, Iowa, 50266
Investigational Site Number 840323
West Palm Beach, Florida, 33401
Investigational Site Number 840083
Westwood, New Jersey
Investigational Site Number 840245
Wichita Falls, Texas
Investigational Site Number 840354
Williamsville, New York, 14221
Investigational Site Number 840052
Wilmington, North Carolina, 28401
Investigational Site Number 840223
Winchester, Virginia, 22601
Investigational Site Number 840111
Winfield, Maryland
Investigational Site Number 840263
Youngstown, Ohio, 44501
Investigational Site Number 840035
Ypsilanti, Michigan, 48197
China63 sites
Investigational Site Number 156022
Baotou, 014010
Investigational Site Number 156004
Beijing, 100020
Investigational Site Number 156005
Beijing, 100029
Investigational Site Number 156006
Beijing, 100029
Investigational Site Number 156001
Beijing, 100034
Investigational Site Number 156082
Beijing, 100048
Investigational Site Number 156009
Beijing, 100049
Investigational Site Number 156003
Beijing, 100730
Investigational Site Number 156002
Beijing, 100853
Investigational Site Number 156013
Changchun, 130021
Investigational Site Number 156064
Changchun, 130021
Investigational Site Number 156052
Changsha, 410005
Investigational Site Number 156053
Changsha, 410011
Investigational Site Number 156088
Changsha, 410013
Investigational Site Number 156057
Chongqing, 400037
Investigational Site Number 156070
Fuzhou, 350005
Investigational Site Number 156079
Fuzhou, 354200
Investigational Site Number 156059
Guangzhou, 510080
Investigational Site Number 156060
Guangzhou, 510080
Investigational Site Number 156071
Guangzhou, 510120
Investigational Site Number 156061
Guangzhou, 510515
Investigational Site Number 156072
Guiyang, 550002
Investigational Site Number 156047
Hangzhou, 310003
Investigational Site Number 156077
Hangzhou, 310006
Investigational Site Number 156048
Hangzhou, 310009
Investigational Site Number 156068
Hangzhou, 310013
Investigational Site Number 156078
Hangzhou, 310014
Investigational Site Number 156046
Hangzhou, 310016
Investigational Site Number 156020
Hohhot, 010017
Investigational Site Number 156032
Jinan, 250013
Investigational Site Number 156031
Jinan, 250033
Investigational Site Number 156027
Lanzhou, 730000
Investigational Site Number 156074
Lanzhou, 730030
Investigational Site Number 156081
Luzhou, 646000
Investigational Site Number 156054
Nanchang, 330006
Investigational Site Number 156055
Nanchang, 330006
Investigational Site Number 156034
Nanjing, 210008
Investigational Site Number 156035
Nanjing, 210009
Investigational Site Number 156039
Shanghai, 200025
Investigational Site Number 156076
Shanghai, 200030
Investigational Site Number 156044
Shanghai, 200032
Investigational Site Number 156043
Shanghai, 200080
Investigational Site Number 156038
Shanghai, 200120
Investigational Site Number 156040
Shanghai, 200233
Investigational Site Number 156016
Shenyang, 110001
Investigational Site Number 156017
Shenyang, 110004
Investigational Site Number 156073
Shenzhen, 518020
Investigational Site Number 156084
Shenzhen, 518036
Investigational Site Number 156063
Siping, 136000
Investigational Site Number 156037
Suzhou, 215006
Investigational Site Number 156066
Tianjin, 300052
Investigational Site Number 156067
Tianjin, 300121
Investigational Site Number 156083
Tianjin, 300140
Investigational Site Number 156025
Tianjin, 300457
Investigational Site Number 156065
Wenzhou, 325000
Investigational Site Number 156051
Wuhan, 430022
Investigational Site Number 156087
Wuhan, 430033
Investigational Site Number 156029
Xi'an, 710061
Investigational Site Number 156086
Xi'an, 710068
Investigational Site Number 156062
Xuzhou, 221002
Investigational Site Number 156014
Yanji, 133000
Investigational Site Number 156075
Yueyang, 414000
Investigational Site Number 156080
Zhanjiang, 524001
India56 sites
Investigational Site Number 356060
Ahmedabad, 380008
Investigational Site Number 356025
Bangalore, 560017
Investigational Site Number 356028
Bangalore, 560034
Investigational Site Number 356083
Bangalore, 560038
Investigational Site Number 356018
Bangalore, 560052
Investigational Site Number 356026
Bangalore, 560054
Investigational Site Number 356084
Bangalore, 560102
Investigational Site Number 356103
Belagavi, 590010
Investigational Site Number 356019
Bikaner
Investigational Site Number 356013
Chennai, 600 037
Investigational Site Number 356012
Chennai, 600006
Investigational Site Number 356081
Chennai, 603203
Investigational Site Number 356056
Chhatrapati Sambhajinagar, 431005
Investigational Site Number 356093
Delhi, 110060
Investigational Site Number 356038
Delhi, 110088
Investigational Site Number 356101
Gūrgaon, 122001
Investigational Site Number 356100
Gūrgaon, 122002
Investigational Site Number 356035
Hyderabad, 500004
Investigational Site Number 356082
Hyderabad, 50063
Investigational Site Number 356015
Jaipur, 302001
Investigational Site Number 356053
Karad, 415110
Investigational Site Number 356102
Karamsad, 388325
Investigational Site Number 356022
Kochi, 682018
Investigational Site Number 356106
Kolhāpur, 416012
Investigational Site Number 356067
Kolkata, 700020
Investigational Site Number 356079
Kolkata, 700027
Investigational Site Number 356069
Kolkata
Investigational Site Number 356089
Ludhiana, 141003
Investigational Site Number 356095
Mangalore, 575002
Investigational Site Number 356071
Mumbai, 400022
Investigational Site Number 356057
Mumbai
Investigational Site Number 356007
Mysore, 570001
Investigational Site Number 356087
Nagpur, 440010
Investigational Site Number 356098
Nagpur, 440012
Investigational Site Number 356097
Nagpur
Investigational Site Number 356096
Nashik, 422005
Investigational Site Number 356055
New Delhi, 110017
Investigational Site Number 356031
New Delhi, 122001
Investigational Site Number 356041
Panjim, 403001
Investigational Site Number 356077
Pune, 411001
Investigational Site Number 356099
Pune, 411001
Investigational Site Number 356048
Pune, 411004
Investigational Site Number 356049
Pune, 411004
Investigational Site Number 356050
Pune, 411004
Investigational Site Number 356045
Pune, 411011
Investigational Site Number 356046
Pune, 411013
Investigational Site Number 356094
Pune, 411019
Investigational Site Number 356009
Secunderabad, 500 003
Investigational Site Number 356032
Secunderabad, 500003
Investigational Site Number 356042
Secunderabad, Hyderabad, 500003
Investigational Site Number 356091
Surat, 395002
Investigational Site Number 356002
Vijayawada, 520008
Investigational Site Number 356105
Vijaywada, 520002
Investigational Site Number 356033
Visakhapatnam, 530002
Investigational Site Number 356039
Vishkhapattanam, 530013
Investigational Site Number 356104
Wardha, 442004
Argentina52 sites
Investigational Site Number 032012
Adrogué, B1846DSK
Investigational Site Number 032018
Bahía Blanca, B8000AKK
Investigational Site Number 032050
Caba, C1093AAS
Investigational Site Number 032048
Caba, C1118AAE
Investigational Site Number 032023
Caba, C1119ACN
Investigational Site Number 032020
Caba, C1180AAX
Investigational Site Number 032041
Caba, C1181ACH
Investigational Site Number 032011
Caba, C1425AGC
Investigational Site Number 032045
Caba, C1426EGR
Investigational Site Number 032010
Ciudad de Buenos Aires, C1428DCO
Investigational Site Number 032046
Ciudadela, B1702BML
Investigational Site Number 032032
Córdoba, X5000AAW
Investigational Site Number 032019
Córdoba, X5000AAX
Investigational Site Number 032021
Córdoba, X5000EPU
Investigational Site Number 032026
Córdoba, X5000JHQ
Investigational Site Number 032008
Córdoba, X5002AOQ
Investigational Site Number 032049
Córdoba, X5003DCE
Investigational Site Number 032042
Córdoba, X5004BAL
Investigational Site Number 032038
Córdoba, X5006IKK
Investigational Site Number 032031
Córdoba, X5016KEH
Investigational Site Number 032017
Coronel Suárez, B7540GHD
Investigational Site Number 032009
Corrientes, W3400AMZ
Investigational Site Number 032005
Junín, B6000BHA
Investigational Site Number 032001
La Plata, B1900AXI
Investigational Site Number 032040
La Plata, B1906ESC
Investigational Site Number 032033
Mar del Plata, B7600FYK
Investigational Site Number 032014
Mar del Plata, B7600FZN
Investigational Site Number 032016
Mendoza, 5500
Investigational Site Number 032030
Merlo, B1722COV
Investigational Site Number 032036
Morón, B1708CGU
Investigational Site Number 032007
Olivos, 1638
Investigational Site Number 032044
Olivos, B1605DSX
Investigational Site Number 032004
Quilmes, B1878DKF
Investigational Site Number 032025
Rafaela, S2300MMA
Investigational Site Number 032035
Ramos Mejía, B1704ETD
Investigational Site Number 032039
Resistencia, H3500CDM
Investigational Site Number 032028
Rosario, S2000DEJ
Investigational Site Number 032024
Rosario, S2000DSR
Investigational Site Number 032053
Salta, 4400
Investigational Site Number 032037
San Isidro, B1642DCB
Investigational Site Number 032052
San Martin, B1650NBN
Investigational Site Number 032013
San Martin, B1685CSQ
Investigational Site Number 032002
San Miguel de Tucumán, T4000ICL
Investigational Site Number 032034
San Miguel de Tucumán, T4000IFL
Investigational Site Number 032006
San Nicolás, B2900DMH
Investigational Site Number 032043
Santa Fe, S3000EOZ
Investigational Site Number 032003
Santa Fe, S3000FWO
Investigational Site Number 032051
Santa Rosa, L6300DSD
Investigational Site Number 032047
Santiago del Estero, G4200AQK
Investigational Site Number 032029
Venado Tuerto, S2600KUE
Investigational Site Number 032022
Villa María, X5900JKA
Investigational Site Number 032015
Zárate, B2800DGH
Russia43 sites
Investigational Site Number 643027
Barnaul, 656055
Investigational Site Number 643037
Kazan', 420012
Investigational Site Number 643013
Kemerovo, 650002
Investigational Site Number 643020
Krasnodar, 350042
Investigational Site Number 643053
Krasnodar, 350086
Investigational Site Number 643033
Moscow, 101990
Investigational Site Number 643002
Moscow, 111539
Investigational Site Number 643011
Moscow, 117292
Investigational Site Number 643029
Moscow, 121356
Investigational Site Number 643028
Moscow, 121552
Investigational Site Number 643004
Moscow, 125284
Investigational Site Number 643016
Moscow, 125284
Investigational Site Number 643023
Moscow, 127473
Investigational Site Number 643044
Moscow, 127644
Investigational Site Number 643022
Moscow, 129301
Investigational Site Number 643031
Moscow, 129327
Investigational Site Number 643043
Nizhny Novgorod, 603005
Investigational Site Number 643034
Novosibirsk, 630075
Investigational Site Number 643052
Novosibirsk, 630089
Investigational Site Number 643050
Novosibirsk
Investigational Site Number 643035
Omsk, 644112
Investigational Site Number 643039
Perm, 614077
Investigational Site Number 643008
Rostov-on-Don, 344068
Investigational Site Number 643017
Ryazan, 390026
Investigational Site Number 643006
Saint Petersburg, 190013
Investigational Site Number 643015
Saint Petersburg, 190013
Investigational Site Number 643051
Saint Petersburg, 192242
Investigational Site Number 643001
Saint Petersburg, 194044
Investigational Site Number 643030
Saint Petersburg, 194044
Investigational Site Number 643010
Saint Petersburg, 194291
Investigational Site Number 643042
Saint Petersburg, 194354
Investigational Site Number 643007
Saint Petersburg, 196601
Investigational Site Number 643040
Saint Petersburg, 197022
Investigational Site Number 643054
Saint Petersburg, 199106
Investigational Site Number 643012
Saratov, 410028
Investigational Site Number 643021
Saratov, 410028
Investigational Site Number 643003
Saratov, 410053
Investigational Site Number 643014
Saratov, 410054
Investigational Site Number 643049
Tomsk, 634012
Investigational Site Number 643019
Tyumen, 625000
Investigational Site Number 643025
Tyumen, 625026
Investigational Site Number 643045
Voronezh, 394065
Investigational Site Number 643009
Yaroslavl, 150029
Canada42 sites
Investigational Site Number 124033
Calgary, T2N 2T8
Investigational Site Number 124017
Cambridge, N1R 7R1
Investigational Site Number 124013
Cambridge, N3H 3R8
Investigational Site Number 124026
Edmonton, T5H 3V9
Investigational Site Number 124019
Edmonton, T6G 2B7
Investigational Site Number 124016
Edmonton, T6L 5X8
Investigational Site Number 124027
Granby, J2G 1T7
Investigational Site Number 124002
Halifax, B3H 3A7
Investigational Site Number 124051
Hamilton, L8L 2X2
Investigational Site Number 124043
Joliette, J6E 6J2
Investigational Site Number 124045
Kitchener, N2M 1B2
Investigational Site Number 124053
Lévis, G6V4Z5
Investigational Site Number 124015
Longueuil, J4M 2X1
Investigational Site Number 124004
Moncton, E1C 4B7
Investigational Site Number 124040
Montreal, H1T 1C8
Investigational Site Number 124032
Montreal, H2K 4L5
Investigational Site Number 124036
Montreal, H2R 1V6
Investigational Site Number 124042
Montreal, H3G 1A4
Investigational Site Number 124028
New Westminster, V3L 3W4
Investigational Site Number 124008
Newmarket, L3Y 8C3
Investigational Site Number 124005
Oshawa, L1J 2K1
Investigational Site Number 124007
Ottawa, K1Y4W7
Investigational Site Number 124006
Penticton, V2A 3G6
Investigational Site Number 124012
Red Deer, T4N 4E7
Investigational Site Number 124054
Saint-Jérôme, J7Z 5T3
Investigational Site Number 124024
Sainte-Foy, G1V 4G5
Investigational Site Number 124035
Scarborough, M1E 5E9
Investigational Site Number 124047
Sherbrooke, J1H 5N4
Investigational Site Number 124044
St. Catherines, L2N 7L6
Investigational Site Number 124025
St. Georges, G5Y 4T8
Investigational Site Number 124034
St. John's, A1B 3V6
Investigational Site Number 124021
St. John's, NBE 2L4
Investigational Site Number 124009
Surrey, V3V 1N1
Investigational Site Number 124022
Sydney, B1P 1P3
Investigational Site Number 124048
Thetford-Mines, G6G 2V4
Investigational Site Number 124037
Thunder Bay, P7B 6V4
Investigational Site Number 124001
Toronto, M5B 1W8
Investigational Site Number 124049
Trois-Rivières, G8Z 3R6
Investigational Site Number 124039
Vancouver, V5Z 1M9
Investigational Site Number 124023
Victoria, V8R 4R2
Investigational Site Number 124041
Victoria, V8T 5G4
Investigational Site Number 124038
Winnipeg, R2H 2A6
Germany42 sites
Investigational Site Number 276013
Aachen, 52074
Investigational Site Number 276019
Bad Krozingen, 79189
Investigational Site Number 276008
Berlin, 10789
Investigational Site Number 276040
Berlin, 12203
Investigational Site Number 276051
Berlin, 12559
Investigational Site Number 276039
Berlin, 13347
Investigational Site Number 276025
Berlin, 13509
Investigational Site Number 276054
Bernau, 16321
Investigational Site Number 276037
Bielefeld, 33604
Investigational Site Number 276016
Bonn, 53127
Investigational Site Number 276009
Bonn, 53225
Investigational Site Number 276001
Dortmund, 44137
Investigational Site Number 276006
Dortmund, 44137
Investigational Site Number 276031
Dortmund, 44137
Investigational Site Number 276050
Dresden, 01099
Investigational Site Number 276024
Eschweiler, 52249
Investigational Site Number 276028
Essen, 45219
Investigational Site Number 276036
Frankfurt am Main, 60594
Investigational Site Number 276012
Freiburg im Breisgau, 79106
Investigational Site Number 276030
Halle, 06120
Investigational Site Number 276032
Hamburg, 20099
Investigational Site Number 276017
Hamburg, 20246
Investigational Site Number 276027
Hamburg, 22041
Investigational Site Number 276029
Hamm, 59071
Investigational Site Number 276052
Haßloch, 67454
Investigational Site Number 276014
Heidelberg, 69115
Investigational Site Number 276023
Homburg/Saar, 66421
Investigational Site Number 276035
Kassel, 34121
Investigational Site Number 276046
Leipzig, 04103
Investigational Site Number 276020
Limburg, 65549
Investigational Site Number 276026
Lippstadt, 59555
Investigational Site Number 276044
Lübeck, 23560
Investigational Site Number 276021
Magdeburg, 39120
Investigational Site Number 276015
Mainz, 55131
Investigational Site Number 276010
Marburg, 35043
Investigational Site Number 276018
Münster, 48149
Investigational Site Number 276042
Nuremberg, 90402
Investigational Site Number 276048
Peine, 31224
Investigational Site Number 276053
Rotenburg an der Fulda, 36199
Investigational Site Number 276045
Rüdersdorf Bei Berlin, 15562
Investigational Site Number 276002
Stuttgart, 70376
Investigational Site Number 276033
Warendorf, 48231
Brazil41 sites
Investigational Site Number 076029
Aparecida de Goiânia, 74905-410
Investigational Site Number 076032
Belém, 66087-660
Investigational Site Number 076017
Belo Horizonte, 30140-062
Investigational Site Number 076004
Belo Horizonte, 30150-221
Investigational Site Number 076022
Belo Horizonte, 30150-320
Investigational Site Number 076038
Belo Horizonte, 31110-580
Investigational Site Number 076002
Blumenau, 89010906
Investigational Site Number 076011
Brasília, 70390-903
Investigational Site Number 076007
Brasília, 70710-100
Investigational Site Number 076003
Campina Grande do Sul, 83430-000
Investigational Site Number 076006
Campinas, 13015-001
Investigational Site Number 076040
Canoas, 92200-000
Investigational Site Number 076033
Curitiba, 80430-100
Investigational Site Number 076005
Curitiba, 80730-150
Investigational Site Number 076009
Fortaleza, 60110-110
Investigational Site Number 076008
Fortaleza, 60170-320
Investigational Site Number 076012
Goiânia, 74223-130
Investigational Site Number 076021
Goiânia, 74605-020
Investigational Site Number 076019
Passo Fundo, 99010-180
Investigational Site Number 076018
Pelotas, 96015290
Investigational Site Number 076024
Porto Alegre, 90020-090
Investigational Site Number 076026
Porto Alegre, 90110270
Investigational Site Number 076014
Porto Alegre, 90610-000
Investigational Site Number 076001
Porto Alegre, 90620-001
Investigational Site Number 076027
Porto Alegre, 91350-250
Investigational Site Number 076035
Riberao Preto, 14048-900
Investigational Site Number 076010
Rio de Janeiro, 22271-100
Investigational Site Number 076015
Salvador, 40050-410
Investigational Site Number 076041
Salvador, 40050-410
Investigational Site Number 076036
Santo André, 18270170
Investigational Site Number 076031
São Bernardo do Campo, 9780000
Investigational Site Number 076030
São José do Rio Preto, 15015-210
Investigational Site Number 076020
São José do Rio Preto, 15090-000
Investigational Site Number 076025
São Paulo, 01244-030
Investigational Site Number 076042
São Paulo, 01308-050
Investigational Site Number 076039
São Paulo, 01327010
Investigational Site Number 076013
São Paulo, 01418-100
Investigational Site Number 076023
São Paulo, 04024-002
Investigational Site Number 076028
São Paulo, 05403-000
Investigational Site Number 076016
Tatuí, 18270-170
Investigational Site Number 076034
Uberlândia, 38400-368
Spain40 sites
Investigational Site Number 724010
Alcalá de Henares, 28805
Investigational Site Number 724007
Almería, 04120
Investigational Site Number 724037
Barcelona, 08003
Investigational Site Number 724041
Barcelona, 08025
Investigational Site Number 724038
Barcelona, 08035
Investigational Site Number 724008
Barcelona, 08036
Investigational Site Number 724039
Cáceres, 10003
Investigational Site Number 724042
Córdoba, 14004
Investigational Site Number 724027
Fuenlabrada, 28942
Investigational Site Number 724002
Girona, 17007
Investigational Site Number 724013
Granada, 18014
Investigational Site Number 724032
Guadalajara, 19002
Investigational Site Number 724003
Huelva, 21005
Investigational Site Number 724025
L'Hospitalet de Llobregat, 08907
Investigational Site Number 724021
León, 24071
Investigational Site Number 724026
Lleida, 25198
Investigational Site Number 724006
Lugo, 27003
Investigational Site Number 724030
Madrid, 28006
Investigational Site Number 724020
Madrid, 28031
Investigational Site Number 724015
Madrid, 28034
Investigational Site Number 724031
Madrid, 28040
Investigational Site Number 724033
Madrid, 28040
Investigational Site Number 724017
Madrid, 28922
Investigational Site Number 724035
Majadahonda, 28222
Investigational Site Number 724016
Málaga, 29010
Investigational Site Number 724043
Málaga, 29010
Investigational Site Number 724036
Murcia, 30120
Investigational Site Number 724001
Oviedo, 33011
Investigational Site Number 724022
Sabadell, 08208
Investigational Site Number 724029
San Sebastián de los Reyes, 28702
Investigational Site Number 724028
Santander, 39008
Investigational Site Number 724034
Santiago de Compostela, 15706
Investigational Site Number 724014
Seville, 41071
Investigational Site Number 724024
Tarragona, 43007
Investigational Site Number 724019
Valencia, 46010
Investigational Site Number 724009
Valencia, 46015
Investigational Site Number 724011
Valencia, 46017
Investigational Site Number 724023
Valladolid, 47005
Investigational Site Number 724005
Vigo, 36312
Investigational Site Number 724040
Zaragoza, 50009
Japan39 sites
Investigational Site Number 392013
Amagasaki-Shi
Investigational Site Number 392041
Amagasaki-Shi
Investigational Site Number 392029
Fukuoka
Investigational Site Number 392019
Hachioji-Shi
Investigational Site Number 392026
Higashihiroshima-Shi
Investigational Site Number 392024
Higashiibaraki-Gun
Investigational Site Number 392003
Hiroshima
Investigational Site Number 392033
Izumisano
Investigational Site Number 392020
Kanazawa
Investigational Site Number 392015
Kitakyushu-Shi
Investigational Site Number 392017
Kobe
Investigational Site Number 392028
Kobe
Investigational Site Number 392037
Kobe
Investigational Site Number 392025
Koga-Shi
Investigational Site Number 392010
Komatsu-Shi
Investigational Site Number 392035
Komatsushima-Shi
Investigational Site Number 392023
Kumamoto
Investigational Site Number 392031
Kumamoto
Investigational Site Number 392039
Kure-Shi
Investigational Site Number 392012
Kurume-Shi
Investigational Site Number 392032
Kusatsu-Shi
Investigational Site Number 392001
Kyoto
Investigational Site Number 392027
Minatoku
Investigational Site Number 392016
Morioka
Investigational Site Number 392005
Nagoya
Investigational Site Number 392022
Nerima-Ku
Investigational Site Number 392009
Osaka
Investigational Site Number 392011
Osaka
Investigational Site Number 392040
Osaka
Investigational Site Number 392004
Sagamihara-Shi
Investigational Site Number 392036
Sapporo
Investigational Site Number 392034
Shinagawa-Ku
Investigational Site Number 392018
Suita-Shi
Investigational Site Number 392002
tabashi City
Investigational Site Number 392014
tabashi City
Investigational Site Number 392030
Tokushima
Investigational Site Number 392008
Urasoe-Shi
Investigational Site Number 392006
Yokohama
Investigational Site Number 392021
Yokohama
Poland36 sites
Investigational Site Number 616026
Bydgoszcz, 85-094
Investigational Site Number 616029
Bydgoszcz, 85-681
Investigational Site Number 616010
Chrzanów, 40-635
Investigational Site Number 616036
Czeladź, 41-250
Investigational Site Number 616034
Gdansk, 80-462
Investigational Site Number 616015
Gdansk, 80-952
Investigational Site Number 616035
Gdynia, 81-394
Investigational Site Number 616005
Gdynia, 81-402
Investigational Site Number 616033
Gdynia, 81-472
Investigational Site Number 616037
Grodzisk Mazowiecki, 05-825
Investigational Site Number 616030
Jelenia Góra, 58-506
Investigational Site Number 616031
Krakow, 30-901
Investigational Site Number 616002
Krakow, 31-121
Investigational Site Number 616012
Łęczna, 21-010
Investigational Site Number 616017
Legnica, 59-220
Investigational Site Number 616019
Lodz, 91-078
Investigational Site Number 616016
Lubin, 59-301
Investigational Site Number 616021
Oława, 55-200
Investigational Site Number 616039
Olsztyn, 10-561
Investigational Site Number 616003
Płock, 09-402
Investigational Site Number 616011
Poznan, 61-289
Investigational Site Number 616018
Puławy, 24-100
Investigational Site Number 616006
Skierniewice, 96-100
Investigational Site Number 616027
Sobótka, 55-050
Investigational Site Number 616007
Sokółka, 16-100
Investigational Site Number 616022
Świdnik, 21-040
Investigational Site Number 616024
Szczecin, 70-506
Investigational Site Number 616004
Torun, 87-100
Investigational Site Number 616013
Torun, 87-100
Investigational Site Number 616025
Torun, 87-100
Investigational Site Number 616032
W?Grów, 07-100
Investigational Site Number 616040
Warsaw, 00-444
Investigational Site Number 616020
Warsaw, 01-142
Investigational Site Number 616038
Warsaw, 02-672
Investigational Site Number 616008
Warsaw, 04-073
Investigational Site Number 616041
Wroclaw, 50-315
United Kingdom35 sites
Investigational Site Number 826018
Basildon, SS16 5NL
Investigational Site Number 826015
Birmingham, B18 7QH
Investigational Site Number 826030
Birmingham, B9 5SS
Investigational Site Number 826038
Bournemouth, BH7 7DW
Investigational Site Number 826025
Bradford, BD9 6RJ
Investigational Site Number 826027
Burton-on-Trent, DE13 0RB
Investigational Site Number 826017
Cardiff, CF14 4XW
Investigational Site Number 826010
Chertsey, KT16 0PZ
Investigational Site Number 826012
Chesterfield, S44 5BL
Investigational Site Number 826039
Chichester, PO19 4SE
Investigational Site Number 826024
Cumbria, LA14 4LF
Investigational Site Number 826041
Dudley, DY1 2HQ
Investigational Site Number 826021
Harrow, HA1 3UJ
Investigational Site Number 826026
High Wycombe, HP11 2TT
Investigational Site Number 826028
Hull, HU16 5JQ
Investigational Site Number 826034
London, E2 9JX
Investigational Site Number 826004
Manchester, M13 9WL
Investigational Site Number 826011
Newcastle upon Tyne, NE7 7DN
Investigational Site Number 826036
Northampton, NN1 5BD
Investigational Site Number 826019
Peterborough, PE3 9GZ
Investigational Site Number 826020
Plymouth, PL6 8DH
Investigational Site Number 826040
Portadown, BT63 5QQ
Investigational Site Number 826016
Portsmouth, PO6 3LY
Investigational Site Number 826014
Redhill, RH1 5RH
Investigational Site Number 826007
Rhyl, LL18 5UJ
Investigational Site Number 826001
Romford, RM7 0AG
Investigational Site Number 826009
Rotherham, S60 2UD
Investigational Site Number 826002
Sheffield, S10 2RX
Investigational Site Number 826032
South Shields, NE34 0PL
Investigational Site Number 826013
St Leonards, TN37 7RD
Investigational Site Number 826005
Stoke-on-Trent, ST4 6QG
Investigational Site Number 826031
Sunderland, SR4 7TP
Investigational Site Number 826022
Truro, TR1 3LJ
Investigational Site Number 826035
Wigan, WN1 2NN
Investigational Site Number 826003
Worcester, WR5 1DD
Netherlands32 sites
Investigational Site Number 528006
Alkmaar, 1815 JD
Investigational Site Number 528022
Amsterdam, 1061 AE
Investigational Site Number 528026
Amsterdam, 1091 AC
Investigational Site Number 528021
Apeldoorn, 7314 ET
Investigational Site Number 528029
Arnhem, 6815 AD
Investigational Site Number 528004
Breda, 4818 CK
Investigational Site Number 528002
Delft, 2625 AD
Investigational Site Number 528007
Eindhoven, 5602 ZA
Investigational Site Number 528032
Goes, 4462 RA
Investigational Site Number 528012
Gouda, 2803 HH
Investigational Site Number 528001
Groningen, 9728 NT
Investigational Site Number 528025
Haarlem, 2035 RC
Investigational Site Number 528023
Hardenberg, 7702 SE
Investigational Site Number 528024
Heerenveen, 8441PW
Investigational Site Number 528016
Hoorn, 1624 NP
Investigational Site Number 528019
Leeuwarden, 8934 AD
Investigational Site Number 528008
Leiden, 2333 ZA
Investigational Site Number 528017
Meppel, 7943 KA
Investigational Site Number 528030
Nieuwegein, 3435 CM
Investigational Site Number 528011
Nijmegen, 6500 HB
Investigational Site Number 528015
Purmerend, 1441RN
Investigational Site Number 528018
Roosendaal, 4708 AE
Investigational Site Number 528014
Rotterdam, 3045 PM
Investigational Site Number 528027
Rotterdam, 3079
Investigational Site Number 528005
Sneek, 8601
Investigational Site Number 528034
Tiel, 4002 WP
Investigational Site Number 528013
Tilburg, 5022 GC
Investigational Site Number 528028
Uden, 5406 PT
Investigational Site Number 528009
Venlo, 5912 BL
Investigational Site Number 528033
Zaandam, 1502 DV
Investigational Site Number 528031
Zutphen, 7207 AE
Investigational Site Number 528020
Zwolle, 8011 JW
Ukraine32 sites
Investigational Site Number 804015
Chernivtsi, 58013
Investigational Site Number 804018
Dnipropetrovsk
Investigational Site Number 804027
Donetsk, 83114
Investigational Site Number 804012
Donetsk
Investigational Site Number 804010
Ivano-Frankivsk, 76018
Investigational Site Number 804006
Kharkiv, 61002
Investigational Site Number 804003
Kharkiv, 61176
Investigational Site Number 804009
Kharkiv
Investigational Site Number 804020
Khmelnytskyi, 29000
Investigational Site Number 804001
Kiev, 02091
Investigational Site Number 804002
Kiev, 02660
Investigational Site Number 804011
Kyiv, 01601
Investigational Site Number 804014
Kyiv, 01601
Investigational Site Number 804025
Kyiv, 03049
Investigational Site Number 804034
Kyiv, 03110
Investigational Site Number 804036
Kyiv, 03115
Investigational Site Number 804016
Kyiv, 03680
Investigational Site Number 804030
Kyiv, 04050
Investigational Site Number 804028
Lutsk, 43024
Investigational Site Number 804033
Lviv, 79010
Investigational Site Number 804031
Lviv, 79059
Investigational Site Number 804029
Mykolaiv, 54003
Investigational Site Number 804004
Odesa, 65014
Investigational Site Number 804013
Odesa, 65025
Investigational Site Number 804017
Simferopol, 95026
Investigational Site Number 804035
Sumy, 40021
Investigational Site Number 804007
Uzhhorod, 88014
Investigational Site Number 804005
Vinnitsya, 21100
Investigational Site Number 804008
Vinnytsia, 21018
Investigational Site Number 804026
Zaporizhia, 69005
Investigational Site Number 804024
Zhytomyr, 10002
Investigational Site Number 804032
Zhytomyr, 10002
Israel27 sites
Investigational Site Number 376006
Afula, 18101
Investigational Site Number 376024
Afula, 18101
Investigational Site Number 376009
Ashkelon, 78278
Investigational Site Number 376012
Beersheba, 84101
Investigational Site Number 376011
Haifa, 31048
Investigational Site Number 376017
Haifa, 31048
Investigational Site Number 376025
Haifa, 31048
Investigational Site Number 376018
Haifa, 31096
Investigational Site Number 376007
Holon, 58100
Investigational Site Number 376021
Holon, 58100
Investigational Site Number 376016
Jerusalem, 91031
Investigational Site Number 376005
Jerusalem, 91120
Investigational Site Number 376027
Jerusalem, 91120
Investigational Site Number 376002
Kfar Saba, 44281
Investigational Site Number 376013
Kfar Saba, 44281
Investigational Site Number 376004
Nahariya, 22100
Investigational Site Number 376015
Nazareth, 16100
Investigational Site Number 376001
Petah Tikva, 49100
Investigational Site Number 376019
Petah Tikva, 49100
Investigational Site Number 376020
Rehovot, 76100
Investigational Site Number 376003
Safed, 13100
Investigational Site Number 376008
Safed, 13100
Investigational Site Number 376010
Tel Aviv, 64239
Investigational Site Number 376014
Tel Aviv, 64239
Investigational Site Number 376022
Tel HaShomer, 52621
Investigational Site Number 376023
Tiberias, 15208
Investigational Site Number 376026
Tzrifin, 70300
Australia25 sites
Investigational Site Number 036002
Ashford, 5035
Investigational Site Number 036023
Auchenflower, 4066
Investigational Site Number 036024
Ballarat, 3353
Investigational Site Number 036020
Bedford Park, 5042
Investigational Site Number 036015
Bruce, 2617
Investigational Site Number 036026
Cairns, 4870
Investigational Site Number 036005
Chermside, 4032
Investigational Site Number 036008
Chermside, 4032
Investigational Site Number 036011
Coffs Harbour, 2450
Investigational Site Number 036003
Concord, 2137
Investigational Site Number 036017
Elizabeth Vale, 5112
Investigational Site Number 036006
Fullarton, 5063
Investigational Site Number 036004
Gosford, 2250
Investigational Site Number 036019
Heidelberg West, 3081
Investigational Site Number 036027
Hobart, 7001
Investigational Site Number 036009
Kogarah, 2217
Investigational Site Number 036012
Mildura, 3500
Investigational Site Number 036028
Nambour, 4560
Investigational Site Number 036013
New Lambton, 2305
Investigational Site Number 036010
Perth, 6000
Investigational Site Number 036014
Prahran, 3004
Investigational Site Number 036018
Redcliffe, 4020
Investigational Site Number 036022
Richmond, 3121
Investigational Site Number 036025
Woodville South, 5011
Investigational Site Number 036021
Woolloongabba, 4102
Italy24 sites
Investigational Site Number 380019
Augusta, 96100
Investigational Site Number 380017
Bergamo, 24127
Investigational Site Number 380026
Brescia, 25123
Investigational Site Number 380008
Brescia, 25124
Investigational Site Number 380012
Ferrara, 44100
Investigational Site Number 380027
Forlì, 47100
Investigational Site Number 380015
Livorno, 57125
Investigational Site Number 380033
Massa, 54100
Investigational Site Number 380030
Milan, 20132
Investigational Site Number 380005
Milan, 20138
Investigational Site Number 380003
Milan, 20148
Investigational Site Number 380025
Monza, 20900
Investigational Site Number 380001
Naples, 80100
Investigational Site Number 380002
Naples, 80131
Investigational Site Number 380021
Novara, 28100
Investigational Site Number 380009
Osio Sotto, 24040
Investigational Site Number 380007
Palermo, 90127
Investigational Site Number 380013
Perugia, 06132
Investigational Site Number 380031
Rho, 20017
Investigational Site Number 380014
Rimini, 47900
Investigational Site Number 380024
Roma, 00152
Investigational Site Number 380028
Seriate, 24068
Investigational Site Number 380032
Treviso, 31100
Investigational Site Number 380020
Vittorio Veneto, 31029
Czechia22 sites
Investigational Site Number 203003
Brno, 62500
Investigational Site Number 203020
Česká Lípa, 470 01
Investigational Site Number 203025
Český Krumlov, 38101
Investigational Site Number 203023
Hodonín, 695 01
Investigational Site Number 203006
Hradec Králové, 50005
Investigational Site Number 203019
Kladno, 272 59
Investigational Site Number 203005
Kladno, 272 80
Investigational Site Number 203008
Kroměříž, 767 01
Investigational Site Number 203015
Liberec, 46063
Investigational Site Number 203024
Mariánské Lázně, 353 01
Investigational Site Number 203013
Olomouc, 77520
Investigational Site Number 203016
Ostrava, 72880
Investigational Site Number 203014
Pardubice, 53203
Investigational Site Number 203018
Pilsen, 30599
Investigational Site Number 203011
Prague, 10034
Investigational Site Number 203017
Prague, 12808
Investigational Site Number 203004
Prague, 14021
Investigational Site Number 203021
Prague, 14059
Investigational Site Number 203012
Prague, 15030
Investigational Site Number 203007
Praha 5 - Motol, 15006
Investigational Site Number 203009
Rakovník, 269 01
Investigational Site Number 203010
Zlín, 76275
France22 sites
Investigational Site Number 250003
Besançon, 25000
Investigational Site Number 250007
Brest, 29609
Investigational Site Number 250010
Cambrai, 59409
Investigational Site Number 250018
Clermont-Ferrand, 63003
Investigational Site Number 250021
Compiègne, 60321
Investigational Site Number 250002
Dijon, 21000
Investigational Site Number 250001
Grenoble, 38043
Investigational Site Number 250009
Limoges, 87042
Investigational Site Number 250019
Marseille, 13015
Investigational Site Number 250008
Massy, 91300
Investigational Site Number 250005
Montfermeil, 93370
Investigational Site Number 250023
Montpellier, 34295
Investigational Site Number 250025
Nantes, 44093
Investigational Site Number 250017
Nice, 06002
Investigational Site Number 250020
Paris, 75013
Investigational Site Number 250012
Paris, 75015
Investigational Site Number 250004
Paris, 75018
Investigational Site Number 250015
Paris, 75571
Investigational Site Number 250011
Pau, 64000
Investigational Site Number 250016
Pessac, 33600
Investigational Site Number 250026
Rouen, 76000
Investigational Site Number 250022
Strasbourg, 67091
Belgium21 sites
Investigational Site Number 056016
Aalst, 9300
Investigational Site Number 056003
Antwerp, 2060
Investigational Site Number 056002
Antwerp, B-2020
Investigational Site Number 056008
Bonheiden, 2820
Investigational Site Number 056014
Brasschaat, 2930
Investigational Site Number 056005
Brussels, 1000
Investigational Site Number 056021
Brussels, 1070
Investigational Site Number 056004
Brussels, 1200
Investigational Site Number 056017
Edegem, B-2650
Investigational Site Number 056024
Genk, 3600
Investigational Site Number 056007
Ghent, 9000
Investigational Site Number 056018
Ghent, 9000
Investigational Site Number 056020
La Louvière, 7100
Investigational Site Number 056009
Leuven, 3000
Investigational Site Number 056015
Liège, 4000
Investigational Site Number 056010
Mechelen, 2800
Investigational Site Number 056013
Mol, 2400
Investigational Site Number 056001
Ottignies, 1340
Investigational Site Number 056012
Overpelt, 3900
Investigational Site Number 056006
Roeselare, 8800
Investigational Site Number 056019
Tienen, 3300
South Africa21 sites
Investigational Site Number 710017
Alberton, 1450
Investigational Site Number 710007
Bellville, 7530
Investigational Site Number 710015
Bloemfontein, 9300
Investigational Site Number 710009
Cape Town, 7405
Investigational Site Number 710010
Cape Town, 7925
Investigational Site Number 710005
Chatsworth, 4091
Investigational Site Number 710006
Durban, 4001
Investigational Site Number 710004
Durban, 4052
Investigational Site Number 710002
Durban, 4320
Investigational Site Number 710012
Johannesburg, 2193
Investigational Site Number 710014
Johannesburg
Investigational Site Number 710019
Kempton Park, 1619
Investigational Site Number 710011
Kimberley, 8301
Investigational Site Number 710021
Kuils River, 7580
Investigational Site Number 710018
Parow, 7500
Investigational Site Number 710008
Pretoria, 0040
Investigational Site Number 710016
Pretoria, 0157
Investigational Site Number 710020
Stellenbosch, 7600
Investigational Site Number 710013
Tongaat, 4400
Investigational Site Number 710022
Western Cape, 7500
Investigational Site Number 710003
Worcester, 6850
Mexico20 sites
Investigational Site Number 484005
Aguascalientes, 20230
Investigational Site Number 484015
Aguascalientes, 20230
Investigational Site Number 484004
Culiacán, 80020
Investigational Site Number 484003
Durango, 34000
Investigational Site Number 484010
Guadalajara, 44100
Investigational Site Number 484006
Guadalajara, 44210
Investigational Site Number 484008
Jalapa, 91020
Investigational Site Number 484027
México, 06720
Investigational Site Number 484023
Mexico City, 11850
Investigational Site Number 484019
Mexico City, 14080
Investigational Site Number 484013
Monterrey, 64020
Investigational Site Number 484018
Monterrey, 64060
Investigational Site Number 484011
Monterrey, 64460
Investigational Site Number 484007
Monterrey, 64710
Investigational Site Number 484017
Morelia, 58260
Investigational Site Number 484012
Oaxaca City, 68000
Investigational Site Number 484014
Querétaro, 76000
Investigational Site Number 484009
San Luis Potosí City, 72244
Investigational Site Number 484002
Tijuana, 22500
Investigational Site Number 484020
Toluca, 50130
Peru20 sites
Investigational Site Number 604018
Arequipa
Investigational Site Number 604004
Callao, CALLAO 02
Investigational Site Number 604025
Callao, Callao 02
Investigational Site Number 604022
Cuzco
Investigational Site Number 604013
Ica, 11001
Investigational Site Number 604010
Lima, 051
Investigational Site Number 604008
Lima, 27
Investigational Site Number 604001
Lima, LIMA 01
Investigational Site Number 604007
Lima, LIMA 01
Investigational Site Number 604005
Lima, LIMA 10
Investigational Site Number 604006
Lima, Lima 11
Investigational Site Number 604015
Lima, LIMA 18
Investigational Site Number 604016
Lima, Lima 18
Investigational Site Number 604017
Lima, Lima 27
Investigational Site Number 604019
Lima, Lima 27
Investigational Site Number 604003
Lima, LIMA 29
Investigational Site Number 604024
Lima, LIMA 31
Investigational Site Number 604012
Lima, LIMA 32
Investigational Site Number 604020
Piura, 20001
Investigational Site Number 604023
Trujillo, 13001
Slovakia19 sites
Investigational Site Number 703001
Bardejov, 085 01
Investigational Site Number 703008
Bratislava, 821 01
Investigational Site Number 703020
Bratislava, 821 01
Investigational Site Number 703014
Bratislava, 826 06
Investigational Site Number 703013
Bratislava, 841 08
Investigational Site Number 703023
Dolný Kubín, 02601
Investigational Site Number 703002
Košice, 040 01
Investigational Site Number 703009
Košice, 040 01
Investigational Site Number 703016
Košice, 040 01
Investigational Site Number 703019
Košice, 04001
Investigational Site Number 703007
Košice
Investigational Site Number 703012
Kráľovský Chlmec, 077 01
Investigational Site Number 703006
Lučenec, 984 39
Investigational Site Number 703010
Lučenec, 98401
Investigational Site Number 703003
Nitra, 950 01
Investigational Site Number 703004
Prešov, 080 01
Investigational Site Number 703018
Svidník, 089 01
Investigational Site Number 703022
Trebišov, 075 01
Investigational Site Number 703005
Žilina, 01001
Bulgaria18 sites
Investigational Site Number 100020
Blagoevgrad, 2700
Investigational Site Number 100012
Burgas, 8000
Investigational Site Number 100011
Pazardzhik, 4400
Investigational Site Number 100013
Pleven, 5800
Investigational Site Number 100018
Pleven, 5800
Investigational Site Number 100005
Plovdiv, 4002
Investigational Site Number 100015
Sandanski, 2800
Investigational Site Number 100023
Smolyan, 4700
Investigational Site Number 100017
Sofia, 1142
Investigational Site Number 100007
Sofia, 1202
Investigational Site Number 100001
Sofia, 1233
Investigational Site Number 100004
Sofia, 1233
Investigational Site Number 100010
Sofia, 1309
Investigational Site Number 100019
Sofia, 1336
Investigational Site Number 100016
Sofia, 1431
Investigational Site Number 100003
Sofia, 1527
Investigational Site Number 100022
Varna, 9000
Investigational Site Number 100014
Veliko Tarnovo, 5000
Chile18 sites
Investigational Site Number 152013
Concepción, 4070038
Investigational Site Number 152003
Osorno, 5311092
Investigational Site Number 152017
Punta Arenas, 6210005
Investigational Site Number 152004
Santiago, 7500710
Investigational Site Number 152014
Santiago, 7500710
Investigational Site Number 152001
Santiago, 7500922
Investigational Site Number 152019
Santiago, 7650018
Investigational Site Number 152007
Santiago, 7650568
Investigational Site Number 152012
Santiago, 8053095
Investigational Site Number 152011
Santiago, 832 0000
Investigational Site Number 152006
Santiago, 8380456
Investigational Site Number 152016
Santiago, 8900085
Investigational Site Number 152015
Santiago
Investigational Site Number 152009
Talca
Investigational Site Number 152002
Temuco, 4781156
Investigational Site Number 152008
Valdivia, 5090145
Investigational Site Number 152010
Viña del Mar, 2520000
Investigational Site Number 152018
Viña del Mar, 2520997
Serbia18 sites
Investigational Site Number 688003
Belgrade, 11000
Investigational Site Number 688005
Belgrade, 11000
Investigational Site Number 688006
Belgrade, 11000
Investigational Site Number 688007
Belgrade, 11000
Investigational Site Number 688008
Belgrade, 11000
Investigational Site Number 688010
Belgrade, 11000
Investigational Site Number 688011
Belgrade, 11000
Investigational Site Number 688013
Belgrade, 11000
Investigational Site Number 688015
Belgrade, 11050
Investigational Site Number 688002
Belgrade, 11080
Investigational Site Number 688009
Kamenitz, 21204
Investigational Site Number 688012
Kragujevac, 34000
Investigational Site Number 688016
Leskovac, 16000
Investigational Site Number 688004
Niš, 18000
Investigational Site Number 688001
Niška Banja, 18205
Investigational Site Number 688018
Pančevo, 26 000
Investigational Site Number 688017
Sremska Mitrovica, 22000
Investigational Site Number 688014
Valjevo, 14000
Colombia17 sites
Investigational Site Number 170006
Armenia, 630004
Investigational Site Number 170003
Barranquilla, 08013
Investigational Site Number 170011
Barranquilla
Investigational Site Number 170013
Barranquilla
Investigational Site Number 170018
Bogotá, 11001000
Investigational Site Number 170016
Bogotá, 111211
Investigational Site Number 170022
Bogota D.C.
Investigational Site Number 170010
Cali, 572
Investigational Site Number 170001
Cali
Investigational Site Number 170017
Cartagena, 130010
Investigational Site Number 170004
Cartagena
Investigational Site Number 170008
Espinal - Tolima
Investigational Site Number 170005
Floridablanca, 681004
Investigational Site Number 170002
Manizales, 170004
Investigational Site Number 170007
Medellín, 050012
Investigational Site Number 170009
Medellín
Investigational Site Number 170021
Medellín
Denmark17 sites
Investigational Site Number 208016
Aabenraa, 6200
Investigational Site Number 208012
Aalborg, 9000
Investigational Site Number 208011
Aarhus N, 8200
Investigational Site Number 208002
Copenhagen, 2100
Investigational Site Number 208003
Glostrup Municipality, 2600
Investigational Site Number 208007
Hellerup, 2900
Investigational Site Number 208006
Herning, 7400
Investigational Site Number 208018
Hillerød, 3400
Investigational Site Number 208014
Holbæk, 4300
Investigational Site Number 208013
Hvidovre, 2650
Investigational Site Number 208004
Køge, 4600
Investigational Site Number 208017
Næstved, 4700
Investigational Site Number 208009
Odense C, 5000
Investigational Site Number 208015
Silkeborg, 8600
Investigational Site Number 208008
Slagelse, 4200
Investigational Site Number 208001
Vejle, 7100
Investigational Site Number 208010
Viborg, 8800
Romania17 sites
Investigational Site Number 642001
Brăila, 810249
Investigational Site Number 642003
Bucharest, 010242
Investigational Site Number 642012
Bucharest, 011234
Investigational Site Number 642021
Bucharest, 011461
Investigational Site Number 642007
Bucharest, 014461
Investigational Site Number 642008
Bucharest, 10416
Investigational Site Number 642005
Buzău, 120203
Investigational Site Number 642013
Codlea, 505100
Investigational Site Number 642004
Constanța, 900591
Investigational Site Number 642002
Craiova, 200147
Investigational Site Number 642016
Craiova, 200642
Investigational Site Number 642010
Focşani, 620034
Investigational Site Number 642017
Iași, 700786
Investigational Site Number 642006
Targoviste, 130083
Investigational Site Number 642019
Târgu Mureş, 540136
Investigational Site Number 642015
Târgu Mureş, 540143
Investigational Site Number 642018
Timișoara, 300736
Croatia16 sites
Investigational Site Number 191013
Dubrovnik, 20000
Investigational Site Number 191017
Krapinske Toplice, 49217
Investigational Site Number 191009
Opatija, 51410
Investigational Site Number 191006
Rijeka
Investigational Site Number 191012
Slavonski Brod, 35000
Investigational Site Number 191003
Varaždin, 42000
Investigational Site Number 191001
Zagreb, 10000
Investigational Site Number 191002
Zagreb, 10000
Investigational Site Number 191005
Zagreb, 10000
Investigational Site Number 191007
Zagreb, 10000
Investigational Site Number 191008
Zagreb, 10000
Investigational Site Number 191010
Zagreb, 10000
Investigational Site Number 191011
Zagreb, 10000
Investigational Site Number 191015
Zagreb, 10000
Investigational Site Number 191016
Zagreb, 10000
Investigational Site Number 191018
Zagreb, 10000
Hungary13 sites
Investigational Site Number 348013
Balatonfüred, 8230
Investigational Site Number 348002
Budapest, 1023
Investigational Site Number 348012
Budapest, 1106
Investigational Site Number 348005
Budapest, 1122
Investigational Site Number 348006
Budapest, 1134
Investigational Site Number 348008
Debrecen, 4032
Investigational Site Number 348004
Eger, 3300
Investigational Site Number 348003
Gyula, 5700
Investigational Site Number 348010
Pécs, 7624
Investigational Site Number 348009
Szeged, 6725
Investigational Site Number 348007
Székesfehérvár, 8000
Investigational Site Number 348011
Szombathely, 9700
Investigational Site Number 348001
Zalaegerszeg, 8900
Philippines13 sites
Investigational Site Number 608012
Cavite
Investigational Site Number 608003
Cebu City, 6000
Investigational Site Number 608013
Cebu City, 6000
Investigational Site Number 608010
Davao City, 8000
Investigational Site Number 608011
Davao City, 8000
Investigational Site Number 608006
Iloilo City, 5000
Investigational Site Number 608002
Makati City, 1218
Investigational Site Number 608004
Manila, 1000
Investigational Site Number 608014
Manila, 1000
Investigational Site Number 608005
Quezon, 1102
Investigational Site Number 608001
Quezon City, 1100
Investigational Site Number 608009
Quezon City, 1109
Investigational Site Number 608008
San Juan City, 1500
South Korea13 sites
Investigational Site Number 410013
Busan, 602-715
Investigational Site Number 410003
Busan, 602-739
Investigational Site Number 410002
Daegu, 700-721
Investigational Site Number 410012
Goyang-si, 10326
Investigational Site Number 410001
Gwangju, 501-757
Investigational Site Number 410008
Seongnam, 463-707
Investigational Site Number 410004
Seoul, 06591
Investigational Site Number 410007
Seoul, 07061
Investigational Site Number 410010
Seoul, 110-744
Investigational Site Number 410011
Seoul, 134-727
Investigational Site Number 410006
Seoul, 152-703
Investigational Site Number 410009
Suwon, 443-721
Investigational Site Number 410005
Wŏnju, 220-701
Sweden13 sites
Investigational Site Number 752001
Falun, 791 82
Investigational Site Number 752016
Gothenburg, 41345
Investigational Site Number 752011
Halmstad, 30185
Investigational Site Number 752006
Karlshamn, 378 00
Investigational Site Number 752008
Karlskrona, 371 85
Investigational Site Number 752013
Köping, 721 51
Investigational Site Number 752004
Kristianstad, 29185
Investigational Site Number 752015
Malmö, S-20502
Investigational Site Number 752012
Mölndal, 43180
Investigational Site Number 752009
Stockholm, 11883
Investigational Site Number 752002
Stockholm, 14186
Investigational Site Number 752014
Sundsvall, 85186
Investigational Site Number 752007
Uppsala, 75237
Taiwan13 sites
Investigational Site Number 158003
Changhua, 500
Investigational Site Number 158008
Division of Cardiology, 833
Investigational Site Number 158014
Hsinchu, 30071
Investigational Site Number 158013
Kaohsiung City, 807
Investigational Site Number 158004
Taichung, 402
Investigational Site Number 158009
Tainan, 704
Investigational Site Number 158011
Tainan, 710
Investigational Site Number 158005
Taipei, 104
Investigational Site Number 158001
Taipei, 112
Investigational Site Number 158010
Taipei, 114
Investigational Site Number 158007
Taipei
Investigational Site Number 158012
Taoyuan Hsien
Investigational Site Number 158002
Yunlin
Greece12 sites
Investigational Site Number 300001
Athens, 11521
Investigational Site Number 300002
Athens, 11527
Investigational Site Number 300007
Athens, 16673
Investigational Site Number 300008
Chios
Investigational Site Number 300013
Haidari, 12462
Investigational Site Number 300010
Heraklion, 70013
Investigational Site Number 300005
Ioannina, 45500
Investigational Site Number 300003
Marousi, 151 26
Investigational Site Number 300006
N. Ionia, 14233
Investigational Site Number 300004
Pátrai, 26500
Investigational Site Number 300011
Thessaloniki, 546 36
Investigational Site Number 300009
Thessaloniki, 54642
New Zealand12 sites
Investigational Site Number 554010
Auckland, 1023
Investigational Site Number 554001
Christchurch
Investigational Site Number 554006
Dunedin
Investigational Site Number 554004
Hamilton, 3200
Investigational Site Number 554011
Lower Hutt, 5010
Investigational Site Number 554005
Nelson, 7010
Investigational Site Number 554007
New Plymouth
Investigational Site Number 554002
Otahuhu, 2025
Investigational Site Number 554008
Palmerston North, 4414
Investigational Site Number 554012
Rotorua, 3010
Investigational Site Number 554009
Takapuna, 1309
Investigational Site Number 554003
Wellington
Turkey (Türkiye)12 sites
Investigational Site Number 792007
Adana, 01339
Investigational Site Number 792009
Ankara, 06018
Investigational Site Number 792006
Bursa, 16509
Investigational Site Number 792016
Eskişehir, 26480
Investigational Site Number 792014
Istanbul, 34034
Investigational Site Number 792005
Istanbul, 34098
Investigational Site Number 792011
Istanbul, 34846
Investigational Site Number 792013
Istanbul, 34896
Investigational Site Number 792004
Izmir, 35100
Investigational Site Number 792003
Izmir, 35340
Investigational Site Number 792015
Kocaeli, 41300
Investigational Site Number 792010
Mersin, 33169
Bosnia and Herzegovina11 sites
Investigational Site Number 070001
Banja Luka, 78000
Investigational Site Number 070002
Banja Luka, 78000
Investigational Site Number 070011
Bihać, 77000
Investigational Site Number 070003
Mostar, 8000
Investigational Site Number 070004
Mostar, 8000
Investigational Site Number 070005
Sarajevo, 71000
Investigational Site Number 070007
Sarajevo, 71000
Investigational Site Number 070010
Sarajevo, 71000
Investigational Site Number 070008
Tuzla, 75000
Investigational Site Number 070009
Tuzla, 75000
Investigational Site Number 070006
Zenica, 72000
Thailand11 sites
Investigational Site Number 764001
Bangkok, 10220
Investigational Site Number 764011
Bangkok, 10300
Investigational Site Number 764007
Bangkok, 10400
Investigational Site Number 764012
Bangkok, 10400
Investigational Site Number 764009
Bangkok Noi, 10700
Investigational Site Number 764005
Hat Yai, 90110
Investigational Site Number 764008
Klong Luang, 12120
Investigational Site Number 764002
Moung, 30000
Investigational Site Number 764003
Muang, 50200
Investigational Site Number 764010
Nonthaburi, 11000
Investigational Site Number 764006
Pratumwan, 10400
Sri Lanka10 sites
Investigational Site Number 144002
Colombo, 1000
Investigational Site Number 144003
Colombo, 1000
Investigational Site Number 144004
Colombo, 1000
Investigational Site Number 144010
Colombo, 1000
Investigational Site Number 144005
Colombo, 10250
Investigational Site Number 144006
Colombo, 10250
Investigational Site Number 144001
Colombo, 7000
Investigational Site Number 144008
Kandy, 20000
Investigational Site Number 144009
Kurunegala, 60000
Investigational Site Number 144007
Ragama, 11010
Lithuania9 sites
Investigational Site Number 440004
Kaunas, 50009
Investigational Site Number 440005
Kaunas, 50009
Investigational Site Number 440009
Kaunas, 50128
Investigational Site Number 440008
Kaunas, 50177
Investigational Site Number 440001
Klaipėda, LT-91131
Investigational Site Number 440006
Klaipėda, LT-92288
Investigational Site Number 440002
Vilnius, 07157
Investigational Site Number 440007
Vilnius, 10309
Investigational Site Number 440003
Vilnius, LT-08661
Norway9 sites
Investigational Site Number 578004
Arendal, 4809
Investigational Site Number 578013
Bergen, 5021
Investigational Site Number 578009
Hamar
Investigational Site Number 578006
Kongsvinger, 2226
Investigational Site Number 578003
Oslo
Investigational Site Number 578005
Oslo
Investigational Site Number 578012
Stavanger, 4068
Investigational Site Number 578002
Svelvik, 3060
Investigational Site Number 578011
Tynset, 2500
Portugal9 sites
Investigational Site Number 620004
Almada, 2801-951
Investigational Site Number 620005
Aveiro, 3814-501
Investigational Site Number 620011
Coimbra, 3000-075
Investigational Site Number 620008
Coimbra, 3041-801
Investigational Site Number 620001
Leiria, 2410-197
Investigational Site Number 620003
Ponta Delgada, 9500-370
Investigational Site Number 620002
Setúbal, 2910-446
Investigational Site Number 620010
Vila Franca de Xira, 2600-009
Investigational Site Number 620006
Vila Nova Gaia, 4434-502
Estonia7 sites
Investigational Site Number 233007
Pärnu, 80010
Investigational Site Number 233004
Tallinn, 10138
Investigational Site Number 233002
Tallinn, 11913
Investigational Site Number 233001
Tallinn, 13415
Investigational Site Number 233005
Tallinn, 13419
Investigational Site Number 233003
Tartu, 50406
Investigational Site Number 233006
Viljandimaa, 71024
Georgia7 sites
Investigational Site Number 268004
Batumi, 6010
Investigational Site Number 268001
Kutaisi, 4600
Investigational Site Number 268005
Tbilisi, 102
Investigational Site Number 268002
Tbilisi, 159
Investigational Site Number 268003
Tbilisi, 159
Investigational Site Number 268008
Tbilisi, 159
Investigational Site Number 268009
Tbilisi, 159
Malaysia7 sites
Investigational Site Number 458004
Batu Caves, 68100
Investigational Site Number 458007
Kota Bharu, 16150
Investigational Site Number 458006
Kota Kinabalu, 88300
Investigational Site Number 458002
Kuala Lumpur, 50400
Investigational Site Number 458005
Kuala Lumpur, 56000
Investigational Site Number 458003
Kuching, 94300
Investigational Site Number 458001
Sungai Buloh, 47000
Austria6 sites
Investigational Site Number 040004
Feldkirch, 6800
Investigational Site Number 040007
Graz, 8036
Investigational Site Number 040001
Salzburg, 5020
Investigational Site Number 040006
Vienna, 1030
Investigational Site Number 040003
Vienna, 1090
Investigational Site Number 040002
Vienna, 1160
Latvia6 sites
Investigational Site Number 428004
Daugavpils, LV-5417
Investigational Site Number 428002
Liepāja, LV-3414
Investigational Site Number 428006
Riga, LV-1002
Investigational Site Number 428001
Riga, LV-1011
Investigational Site Number 428005
Riga, LV-1038
Investigational Site Number 428003
Ventspils, LV-3601
North Macedonia5 sites
Investigational Site Number 807005
Bitola, 7000
Investigational Site Number 807004
Shtip, 2000
Investigational Site Number 807002
Skopje, 1000
Investigational Site Number 807001
Skopje, 1109
Investigational Site Number 807003
Tetovo, 1200
Slovenia5 sites
Investigational Site Number 705001
Celje, 3000
Investigational Site Number 705004
Izola, 6310
Investigational Site Number 705002
Jesenice, 4270
Investigational Site Number 705005
Ljubljana, 1525
Investigational Site Number 705006
Ljubljana, SI-1525
Finland4 sites
Investigational Site Number 246004
Helsinki, 00029 HUS
Investigational Site Number 246001
Oulu, 90220
Investigational Site Number 246003
Tampere, 33520
Investigational Site Number 246002
Turku, 20520
Guatemala4 sites
Investigational Site Number 320003
Guatemala City, 01001
Investigational Site Number 320001
Guatemala City, 01014
Investigational Site Number 320002
Guatemala City
Investigational Site Number 320004
Guatemala City
Switzerland4 sites
Investigational Site Number 756005
Basel, 4031
Investigational Site Number 756003
Geneva, 1205
Investigational Site Number 756004
Lugano, 6900
Investigational Site Number 756002
Zurich, 8091
Singapore3 sites
Investigational Site Number 702002
Singapore, 119228
Investigational Site Number 702003
Singapore, 159964
Investigational Site Number 702001
Singapore, 168752
Hong Kong2 sites
Investigational Site Number 344003
Hong Kong
Investigational Site Number 344001
Shatin, Nt
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Primary Objective:
To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.
Read more
Secondary Objectives:
- To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the effect of alirocumab on lipid parameters.
Read the detailed description
18924 number of participants aged >= 40 years old were randomized in the study.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Alirocumab, Placebo, LMT
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
Also called SAR236553, REGN727, Praluent®
Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.
PlaceboDrug
Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.
LMTDrug
Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months. Receives: Drug: Placebo; Drug: LMT |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Experimental | Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L). Receives: Drug: Alirocumab; Drug: LMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study
All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.
Measured: From randomization up to 64 months
Secondary outcomes (12)
Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death, non-fatal non-fatal MI, UA requiring hospitalization, or ischemia-driven coronary revascularization procedure. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
All Major CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death and non-fatal MI. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any major CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study
All CV events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of any non-fatal CHD event, any CV death and non-fatal IS. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CV event over time. Percentage of observed participants with outcome measure events during the study were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
All-cause mortality, non-fatal MI and non-fatal IS positively adjudicated by CEC in a blinded fashion, were used in the analysis of this endpoint. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of all-cause mortality, non-fatal MI and non-fatal IS over time. Percentage of observed participants with outcome measure events during the study were reported.
Measured: From randomization up to 64 months
Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CHD death over time. Percentage of observed participants with CHD death (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CV death over time. Percentage of observed participants with CV death (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the all-cause death over time. Percentage of observed participants with all-cause death (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any non-fatal MI over time. Percentage of observed participants with any non-fatal MI (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of fatal or any non-fatal IS over time. Percentage of observed participants with fatal or any non-fatal IS (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any UA requiring hospitalization over time. Percentage of observed participants with any UA requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any ischemia-driven coronary revascularization procedure over time. Percentage of observed participants with any ischemia-driven coronary revascularization procedure (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHF requiring hospitalization over time. Percentage of observed participants with any CHF requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.
Measured: From randomization up to 64 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startOct 2012
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18,924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663402
- Sponsor's protocol ID
- EFC11570
- Other IDs
- 2011-005698-21, U1111-1127-4323
- Status last verified
- Mar 2019
- First submitted
- 8 Aug 2012
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tsimikas S, Szarek M, Cobbaert CM, Romijn F, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Yuan C, Gong XM, Goodman SG, White HD, Witztum JL, Steg PG, Schwartz GG; ODYSSEY OUTCOMES Investigators. Oxidized Phospholipids, Lipoprotein(a), and Cardiovascular Outcomes After Acute Coronary Syndrome. Circulation. 2025 Dec 16;152(24):1666-1678. doi: 10.1161/CIRCULATIONAHA.125.073855. Epub 2025 Dec 1.
PubMed 41321238Reijnders E, Bossuyt PM, Jukema JW, Ruhaak LR, Romijn FPHTM, Szarek M, Trompet S, Bhatt DL, Bittner VA, Diaz R, Fazio S, Stevanovic I, Goodman SG, Harrington RA, White HD, Steg PG, Schwartz GG, Cobbaert CM. Multiplex Apolipoprotein Panel Improves Cardiovascular Event Prediction and Cardiovascular Outcome by Identifying Patients Who Benefit From Targeted PCSK9 Inhibitor Therapy. Arterioscler Thromb Vasc Biol. 2025 Nov;45(11):2111-2123. doi: 10.1161/ATVBAHA.124.322336. Epub 2025 Sep 25.
PubMed 40995631Geba GP, Mohammadi KA, Damask A, Paulding C, Lotta LA, Hindy G, Pordy R, Manvelian G, Shapiro MD, Bittner VA, Bhatt DL, Szarek M, Schwartz GG, Steg PG, Fazio S. Effect of PCSK9 Inhibition With Alirocumab in Patients With Probable Familial Hypercholesterolemia or Type III Hyperlipoproteinemia: Results From the ODYSSEY OUTCOMES Trial. J Am Heart Assoc. 2025 Sep 2;14(17):e041190. doi: 10.1161/JAHA.124.041190. Epub 2025 Aug 22.
PubMed 40847481Steg PG, Szarek M, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Goodman SG, Harrington RA, White HD, Zeiher AM, Schwartz GG; ODYSSEY OUTCOMES Investigators. Relation of Low-Density Lipoprotein Cholesterol, High-Sensitivity C-Reactive Protein, and Lipoprotein(a) Each to Future Cardiovascular Events and Death After Acute Coronary Syndrome on High-Intensity Statin Therapy: An Analysis of the Placebo Arm of ODYSSEY OUTCOMES. Circulation. 2025 Apr 8;151(14):1047-1050. doi: 10.1161/CIRCULATIONAHA.124.071269. Epub 2025 Apr 7. No abstract available.
PubMed 40193536Geba GP, Chen R, Talapatra K, Brackin T, Mohammadi KA, Pordy R, Manvelian G, Maron DJ, Schwartz GG, Szarek M, Steg PG, Fazio S. Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES. Am J Prev Cardiol. 2024 Nov 26;20:100900. doi: 10.1016/j.ajpc.2024.100900. eCollection 2024 Dec.
PubMed 39687787Reijnders E, Romijn FPHTM, Arslan F, Georges JJJ, Pieterse MM, Schipper ER, Didden-Buitendijk S, Martherus-Bultman MC, Smit NPM, Diederiks NM, Treep MM, Jukema JW, Cobbaert CM, Ruhaak LR. Quality Assurance for Multiplex Quantitative Clinical Chemistry Proteomics in Large Clinical Trials. J Appl Lab Med. 2024 Nov 4;9(6):949-963. doi: 10.1093/jalm/jfae092.
PubMed 39239905Zahger D, Schwartz GG, Du W, Szarek M, Bhatt DL, Bittner VA, Budaj AJ, Diaz R, Goodman SG, Jukema JW, Kiss RG, Harrington RA, Moriarty PM, Scemama M, Manvelian G, Pordy R, White HD, Zeiher AM, Fazio S, Geba GP, Steg PG; ODYSSEY OUTCOMES Investigators. Triglyceride Levels, Alirocumab Treatment, and Cardiovascular Outcomes After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Sep 10;84(11):994-1006. doi: 10.1016/j.jacc.2024.06.035.
PubMed 39232634Bittner VA, Schwartz GG, Bhatt DL, Chua T, De Silva HA, Diaz R, Goodman SG, Harrington RA, Jukema JW, McGinniss J, Pordy R, Garon G, Scemama M, White HD, Steg PG, Szarek M; ODYSSEY OUTCOMES Investigators. Alirocumab and cardiovascular outcomes according to sex and lipoprotein(a) after acute coronary syndrome: a report from the ODYSSEY OUTCOMES study. J Clin Lipidol. 2024 Jul-Aug;18(4):e548-e561. doi: 10.1016/j.jacl.2024.04.122. Epub 2024 Apr 10.
PubMed 38960812Lawler PR, Manvelian G, Coppi A, Damask A, Cantor MN, Ferreira MAR, Paulding C, Banerjee N, Li D, Jorgensen S, Attre R, Carey DJ, Krebs K, Milani L, Hveem K, Damas JK, Solligard E, Stender S, Tybjaerg-Hansen A, Nordestgaard BG, Hernandez-Beeftink T, Rogne T, Flores C, Villar J, Walley KR, Liu VX, Fohner AE, Lotta LA, Kyratsous CA, Sleeman MW, Scemama M, DelGizzi R, Pordy R, Horowitz JE, Baras A, Martin GS, Steg PG, Schwartz GG, Szarek M, Goodman SG. Pharmacologic and Genetic Downregulation of Proprotein Convertase Subtilisin/Kexin Type 9 and Survival From Sepsis. Crit Care Explor. 2023 Nov 8;5(11):e0997. doi: 10.1097/CCE.0000000000000997. eCollection 2023 Nov.
PubMed 37954898Goodman SG, Steg PG, Poulouin Y, Bhatt DL, Bittner VA, Diaz R, Garon G, Harrington RA, Jukema JW, Manvelian G, Stipek W, Szarek M, White HD, Schwartz GG; ODYSSEY OUTCOMES Investigators. Long-Term Efficacy, Safety, and Tolerability of Alirocumab in 8242 Patients Eligible for 3 to 5 Years of Placebo-Controlled Observation in the ODYSSEY OUTCOMES Trial. J Am Heart Assoc. 2023 Sep 19;12(18):e029216. doi: 10.1161/JAHA.122.029216. Epub 2023 Sep 13. No abstract available.
PubMed 37702079Szarek M, Reijnders E, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Goodman SG, Harrington RA, Ruhaak LR, Schwertfeger M, Tsimikas S, White HD, Steg PG, Cobbaert C, Schwartz GG; ODYSSEY OUTCOMES Investigators. Relating Lipoprotein(a) Concentrations to Cardiovascular Event Risk After Acute Coronary Syndrome: A Comparison of 3 Tests. Circulation. 2024 Jan 16;149(3):192-203. doi: 10.1161/CIRCULATIONAHA.123.066398. Epub 2023 Aug 26.
PubMed 37632469Suc G, Schwartz GG, Goodman SG, Jukema JW, Manvelian G, Poulouin Y, Pordy R, Scemama M, Szarek M, Steg PG; ODYSSEY OUTCOMES Investigators. Effect of alirocumab on cataracts in patients with acute coronary syndromes. BMC Ophthalmol. 2023 Jun 16;23(1):279. doi: 10.1186/s12886-023-03012-1.
PubMed 37328736Schwartz GG, Szarek M, Bhatt DL, Bittner VA, Bujas-Bobanovic M, Diaz R, Fazio S, Fras Z, Goodman SG, Harrington RA, Jukema JW, Manvelian G, Pordy R, Ray KK, Scemama M, White HD, Steg PG; ODYSSEY OUTCOMES Investigators. Transiently achieved very low LDL-cholesterol levels by statin and alirocumab after acute coronary syndrome are associated with cardiovascular risk reduction: the ODYSSEY OUTCOMES trial. Eur Heart J. 2023 Mar 5;44(16):1408-17. doi: 10.1093/eurheartj/ehad144. Online ahead of print.
PubMed 36879424Hagstrom E, Steg PG, Szarek M, Bhatt DL, Bittner VA, Danchin N, Diaz R, Goodman SG, Harrington RA, Jukema JW, Liberopoulos E, Marx N, McGinniss J, Manvelian G, Pordy R, Scemama M, White HD, Zeiher AM, Schwartz GG; ODYSSEY OUTCOMES Investigators. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab. Circulation. 2022 Aug 30;146(9):657-672. doi: 10.1161/CIRCULATIONAHA.121.057807. Epub 2022 Jun 30.
PubMed 35770629Landmesser U, McGinniss J, Steg PG, Bhatt DL, Bittner VA, Diaz R, Dilic M, Goodman SG, Jukema JW, Loy M, Pecin I, Pordy R, Poulsen SH, Szarek M, White HD, Schwartz GG; ODYSSEY OUTCOMES Investigators. Achievement of ESC/EAS LDL-C treatment goals after an acute coronary syndrome with statin and alirocumab. Eur J Prev Cardiol. 2022 Oct 20;29(14):1842-1851. doi: 10.1093/eurjpc/zwac107.
PubMed 35708715
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01663402
- Acronym / sponsor ID
- EFC11570
- Conditions
- Atherosclerotic Cardiovascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,924 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Oct 2012 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Posted 18 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.
Secondary Objectives:
- To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the effect of alirocumab on lipid parameters.
Detailed description
18924 number of participants aged >= 40 years old were randomized in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: LMTPlacebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months. |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Experimental | Drug: Alirocumab, Drug: LMTAlirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recently (< 52 weeks) hospitalized for ACS.
Key exclusion criteria (4 listed)
- Age < 40 years.
- ACS event occurring more than 52 weeks prior to randomization visit.
- LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlirocumabAlso: SAR236553, REGN727, Praluent®Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector. | Drug | Alirocumab 75 mg Q2W/Up to 150 mg Q2W |
| PlaceboPlacebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector. | Drug | Placebo |
| LMTStatins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated. | Drug | Alirocumab 75 mg Q2W/Up to 150 mg Q2W, Placebo |
Primary outcome
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.
12 secondary outcomes
Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Time frame: From randomization up to 64 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41321238Tsimikas S, Szarek M, Cobbaert CM, Romijn F, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Yuan C, Gong XM, Goodman SG, White HD, Witztum JL, Steg PG, Schwartz GG; ODYSSEY OUTCOMES Investigators. Oxidized Phospholipids, Lipoprotein(a), and Cardiovascular Outcomes After Acute Coronary Syndrome. Circulation. 2025 Dec 16;152(24):1666-1678. doi: 10.1161/CIRCULATIONAHA.125.073855. Epub 2025 Dec 1.
- Derived from this study: PubMed 40995631Reijnders E, Bossuyt PM, Jukema JW, Ruhaak LR, Romijn FPHTM, Szarek M, Trompet S, Bhatt DL, Bittner VA, Diaz R, Fazio S, Stevanovic I, Goodman SG, Harrington RA, White HD, Steg PG, Schwartz GG, Cobbaert CM. Multiplex Apolipoprotein Panel Improves Cardiovascular Event Prediction and Cardiovascular Outcome by Identifying Patients Who Benefit From Targeted PCSK9 Inhibitor Therapy. Arterioscler Thromb Vasc Biol. 2025 Nov;45(11):2111-2123. doi: 10.1161/ATVBAHA.124.322336. Epub 2025 Sep 25.
- Derived from this study: PubMed 40847481Geba GP, Mohammadi KA, Damask A, Paulding C, Lotta LA, Hindy G, Pordy R, Manvelian G, Shapiro MD, Bittner VA, Bhatt DL, Szarek M, Schwartz GG, Steg PG, Fazio S. Effect of PCSK9 Inhibition With Alirocumab in Patients With Probable Familial Hypercholesterolemia or Type III Hyperlipoproteinemia: Results From the ODYSSEY OUTCOMES Trial. J Am Heart Assoc. 2025 Sep 2;14(17):e041190. doi: 10.1161/JAHA.124.041190. Epub 2025 Aug 22.
- Derived from this study: PubMed 40193536Steg PG, Szarek M, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Goodman SG, Harrington RA, White HD, Zeiher AM, Schwartz GG; ODYSSEY OUTCOMES Investigators. Relation of Low-Density Lipoprotein Cholesterol, High-Sensitivity C-Reactive Protein, and Lipoprotein(a) Each to Future Cardiovascular Events and Death After Acute Coronary Syndrome on High-Intensity Statin Therapy: An Analysis of the Placebo Arm of ODYSSEY OUTCOMES. Circulation. 2025 Apr 8;151(14):1047-1050. doi: 10.1161/CIRCULATIONAHA.124.071269. Epub 2025 Apr 7. No abstract available.
- Derived from this study: PubMed 39687787Geba GP, Chen R, Talapatra K, Brackin T, Mohammadi KA, Pordy R, Manvelian G, Maron DJ, Schwartz GG, Szarek M, Steg PG, Fazio S. Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES. Am J Prev Cardiol. 2024 Nov 26;20:100900. doi: 10.1016/j.ajpc.2024.100900. eCollection 2024 Dec.
- Derived from this study: PubMed 39239905Reijnders E, Romijn FPHTM, Arslan F, Georges JJJ, Pieterse MM, Schipper ER, Didden-Buitendijk S, Martherus-Bultman MC, Smit NPM, Diederiks NM, Treep MM, Jukema JW, Cobbaert CM, Ruhaak LR. Quality Assurance for Multiplex Quantitative Clinical Chemistry Proteomics in Large Clinical Trials. J Appl Lab Med. 2024 Nov 4;9(6):949-963. doi: 10.1093/jalm/jfae092.
- Derived from this study: PubMed 39232634Zahger D, Schwartz GG, Du W, Szarek M, Bhatt DL, Bittner VA, Budaj AJ, Diaz R, Goodman SG, Jukema JW, Kiss RG, Harrington RA, Moriarty PM, Scemama M, Manvelian G, Pordy R, White HD, Zeiher AM, Fazio S, Geba GP, Steg PG; ODYSSEY OUTCOMES Investigators. Triglyceride Levels, Alirocumab Treatment, and Cardiovascular Outcomes After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Sep 10;84(11):994-1006. doi: 10.1016/j.jacc.2024.06.035.
- Derived from this study: PubMed 38960812Bittner VA, Schwartz GG, Bhatt DL, Chua T, De Silva HA, Diaz R, Goodman SG, Harrington RA, Jukema JW, McGinniss J, Pordy R, Garon G, Scemama M, White HD, Steg PG, Szarek M; ODYSSEY OUTCOMES Investigators. Alirocumab and cardiovascular outcomes according to sex and lipoprotein(a) after acute coronary syndrome: a report from the ODYSSEY OUTCOMES study. J Clin Lipidol. 2024 Jul-Aug;18(4):e548-e561. doi: 10.1016/j.jacl.2024.04.122. Epub 2024 Apr 10.
- Derived from this study: PubMed 37954898Lawler PR, Manvelian G, Coppi A, Damask A, Cantor MN, Ferreira MAR, Paulding C, Banerjee N, Li D, Jorgensen S, Attre R, Carey DJ, Krebs K, Milani L, Hveem K, Damas JK, Solligard E, Stender S, Tybjaerg-Hansen A, Nordestgaard BG, Hernandez-Beeftink T, Rogne T, Flores C, Villar J, Walley KR, Liu VX, Fohner AE, Lotta LA, Kyratsous CA, Sleeman MW, Scemama M, DelGizzi R, Pordy R, Horowitz JE, Baras A, Martin GS, Steg PG, Schwartz GG, Szarek M, Goodman SG. Pharmacologic and Genetic Downregulation of Proprotein Convertase Subtilisin/Kexin Type 9 and Survival From Sepsis. Crit Care Explor. 2023 Nov 8;5(11):e0997. doi: 10.1097/CCE.0000000000000997. eCollection 2023 Nov.
- Derived from this study: PubMed 37702079Goodman SG, Steg PG, Poulouin Y, Bhatt DL, Bittner VA, Diaz R, Garon G, Harrington RA, Jukema JW, Manvelian G, Stipek W, Szarek M, White HD, Schwartz GG; ODYSSEY OUTCOMES Investigators. Long-Term Efficacy, Safety, and Tolerability of Alirocumab in 8242 Patients Eligible for 3 to 5 Years of Placebo-Controlled Observation in the ODYSSEY OUTCOMES Trial. J Am Heart Assoc. 2023 Sep 19;12(18):e029216. doi: 10.1161/JAHA.122.029216. Epub 2023 Sep 13. No abstract available.
- Derived from this study: PubMed 37632469Szarek M, Reijnders E, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Goodman SG, Harrington RA, Ruhaak LR, Schwertfeger M, Tsimikas S, White HD, Steg PG, Cobbaert C, Schwartz GG; ODYSSEY OUTCOMES Investigators. Relating Lipoprotein(a) Concentrations to Cardiovascular Event Risk After Acute Coronary Syndrome: A Comparison of 3 Tests. Circulation. 2024 Jan 16;149(3):192-203. doi: 10.1161/CIRCULATIONAHA.123.066398. Epub 2023 Aug 26.
- Derived from this study: PubMed 37328736Suc G, Schwartz GG, Goodman SG, Jukema JW, Manvelian G, Poulouin Y, Pordy R, Scemama M, Szarek M, Steg PG; ODYSSEY OUTCOMES Investigators. Effect of alirocumab on cataracts in patients with acute coronary syndromes. BMC Ophthalmol. 2023 Jun 16;23(1):279. doi: 10.1186/s12886-023-03012-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1,388 sites in 57 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alirocumab and LMT in people with Atherosclerotic Cardiovascular Disease, run by Sanofi at 1,388 sites in 57 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,388 sites in United States, China, India, Argentina, Russia and 52 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study (time frame: From randomization up to 64 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01663402, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.