AzTrials
AzTrials

Coronary Heart DiseasePhase 3NCT00658515

A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

A Phase 3 study testing Dalcetrapib (RO4607381) and Evidence-based medical care for Acute Coronary Syndrome in people with Coronary Heart Disease, run by Hoffmann-La Roche at 1,089 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
Dalcetrapib (RO4607381) and Evidence-based medical care for Acute Coronary Syndrome
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15,871 participants
Where
1,089 sitesin 29 countries
Study dates
Apr 2008to Sep 2012
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, >=45 years of age;
  • recently hospitalized for ACS;
  • clinically stable;
  • receiving evidence-based medical and dietary management of dyslipidemia.

Who cannot join

  • uncontrolled diabetes;
  • clinically unstable;
  • severe anemia;
  • uncontrolled hypertension;
  • concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Trial locations and contacts

1,089 sites in 29 countries.

876 sites in 29 countries

United States300 sites

  • Study site

    Abington, Pennsylvania, 19001

  • Study site

    Aiken, South Carolina, 29801

  • Study site

    Akron, Ohio, 44304

  • Study site

    Akron, Ohio, 44307

  • Study site

    Albany, New York, 12211

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Allentown, Pennsylvania, 18105

  • Study site

    Alpena, Michigan, 49707

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Ames, Iowa, 50010

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, Indiana, 46060

  • Study site

    Ann Arbor, Michigan, 48105

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Athens, Ohio, 45701

  • Study site

    Atlanta, Georgia, 30303

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Atlanta, Georgia, 30312

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Austin, Texas, 78666

  • Study site

    Austin, Texas, 78756

  • Study site

    Aventura, Florida, 33180

  • Study site

    Bakersfield, California, 93308

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21202

  • Study site

    Baltimore, Maryland, 21218

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Baltimore, Maryland, 21239

  • Study site

    Bangor, Maine, 04401

  • Study site

    Bannockburn, Illinois, 60015

  • Study site

    Bartlesville, Oklahoma, 74006

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bel Air, Maryland, 21014

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Bellflower, California, 90706

  • Study site

    Beloit, Wisconsin, 53511

  • Study site

    Bend, Oregon, 97701

  • Study site

    Beverly Hills, California, 90210

  • Study site

    Biddeford, Maine, 04005

  • Study site

    Billerica, Massachusetts, 01821

  • Study site

    Billings, Montana, 59101

  • Study site

    Birmingham, Alabama, 35213

  • Study site

    Birmingham, Alabama, 35215

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bloomfield, Michigan, 48302

  • Study site

    Boise, Idaho, 83712

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Bridgewater, New Jersey, 08807

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn, New York, 11212

  • Study site

    Brooklyn, New York, 11229

  • Study site

    Bryn Mawr, Pennsylvania, 19010-3121

  • Study site

    Buena Park, California, 90621

  • Study site

    Buffalo, New York, 14203

  • Study site

    Buffalo, New York, 14215

  • Study site

    Burbank, California, 91505-4866

  • Study site

    Burke, Virginia, 22015

  • Study site

    Burlington, Wisconsin, 53105

  • Study site

    Cadillac, Michigan, 49601

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Canton, Ohio, 44708

  • Study site

    Carmichael, California, 95608

  • Study site

    Cary, North Carolina, 27511

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chaska, Minnesota, 55318

  • Study site

    Chicago, Illinois, 60616

  • Study site

    Chipley, Florida, 32428

  • Study site

    Cincinnati, Ohio, 45203-0542

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Clarksburg, West Virginia, 26301

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Clearwater, Florida, 33764

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Clifton, New Jersey, 07012

  • Study site

    Colonial Heights, Virginia, 23834

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, Maryland, 21044

  • Study site

    Columbia, Missouri, 65201

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Concord, North Carolina, 28025

  • Study site

    Corona, California, 92879

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Council Bluffs, Iowa, 51501

  • Study site

    Covington, Georgia, 30014

  • Study site

    Crystal River, Florida, 34429

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75243

  • Study site

    Dallas, Texas, 75390

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Danville, Virginia, 24541-4160

  • Study site

    Danville, Virginia, 24541

  • Study site

    Davenport, Iowa, 52803

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Dearborn, Michigan, 48124

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Deerfield Beach, Florida, 33442

  • Study site

    Delray Beach, Florida, 33445

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Denver, Colorado, 80218

  • Study site

    Denver, Colorado, 80220

  • Study site

    Detroit, Michigan, 48221

  • Study site

    Detroit, Michigan, 48235

  • Study site

    Downingtown, Pennsylvania, 19335

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Duluth, Minnesota, 55802

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Durham, North Carolina, 27710

  • Study site

    East Bridgewater, Massachusetts, 02333

  • Study site

    East Orange, New Jersey, 07018

  • Study site

    Easton, Pennsylvania, 18042

  • Study site

    Edgewater, New Jersey, 07020

  • Study site

    Elizabeth, Florida, 07202

  • Study site

    Elizabeth City, North Carolina, 27909

  • Study site

    Elizabethtown, Kentucky, 42701

  • Study site

    Elkhart, Indiana, 46514

  • Study site

    Elmer, New Jersey, 08318

  • Study site

    Encinitas, California, 92024

  • Study site

    Erie, Pennsylvania, 16502

  • Study site

    Evanston, Illinois, 60202

  • Study site

    Evansville, Indiana, 47710

  • Study site

    Everett, Washington, 98201

  • Study site

    Fairfield, Michigan, 45014

  • Study site

    Falls Church, Virginia, 22042

  • Study site

    Falls Church, Virginia, 22044

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Feasterville, Pennsylvania, 19053

  • Study site

    Fishers, Indiana, 46038

  • Study site

    Fishkill, New York, 12524

  • Study site

    Flint, Michigan, 48504

  • Study site

    Flint, Michigan, 48532

  • Study site

    Flushing, New York, 11355

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fort Wayne, Indiana, 46805

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Franklin, Indiana, 46131

  • Study site

    Fremont, Nebraska, 68025

  • Study site

    Fresno, California, 93720

  • Study site

    Fresno, California, 93721

  • Study site

    Fullerton, California, 92835

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Gainesville, Florida, 32608

  • Study site

    Gainesville, Florida, 32610-0277

  • Study site

    Galax, Virginia, 24333

  • Study site

    Glendale, California, 91204

  • Study site

    Glendale, California, 91206

  • Study site

    Grand Island, Nebraska, 68803

  • Study site

    Great Falls, Montana, 59405

  • Study site

    Greeley, Colorado, 80631

  • Study site

    Green Bay, Wisconsin, 54301

  • Study site

    Green Bay, Wisconsin, 54303

  • Study site

    Greenfield, Indiana, 46140

  • Study site

    Greenville, New Jersey, 29605

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Guilford, Connecticut, 06437

  • Study site

    Gulfport, Mississippi, 39503

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Haddon Heights, New Jersey, 08035

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Hammond, Indiana, 46320-1942

  • Study site

    Hartford, Connecticut, 06115

  • Study site

    Haverhill, Massachusetts, 01830

  • Study site

    Havertown, Pennsylvania, 19083

  • Study site

    Hawaiian Gardens, California, 90716

  • Study site

    Hawthorne, New Jersey, 07506

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Hinsdale, Illinois, 60521

  • Study site

    Hollywood, California, 90028

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    Hopewell, Virginia, 23860

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houston, Texas, 77005

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77070

  • Study site

    Houston, Texas, 77090

  • Study site

    Hudson, Florida, 34667

  • Study site

    Humble, Texas, 77338

  • Study site

    Hyannis, Massachusetts, 02601

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Indianapolis, Indiana, 46250

  • Study site

    Indianapolis, Indiana, 46254

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Inglewood, California, 90301

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jackson, Tennessee, 38301

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Jacksonville Beach, Florida, 32250

  • Study site

    Johnson City, New York, 13790

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kalamazoo, Michigan, 49007

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Kalispell, Montana, 59901

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Killeen, Texas, 76549

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Knoxville, South Dakota, 37920

  • Study site

    Knoxville, Tennessee, 37917

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    La Crosse, Wisconsin, 54601-4795

  • Study site

    La Jolla, California, 92093

  • Study site

    La Mesa, California, 91942

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lake Charles, Louisiana, 70601

  • Study site

    Lake Havasu City, Arizona, 86403

  • Study site

    Lakeland, Florida, 33805

  • Study site

    Lancaster, Pennsylvania, 17603

  • Study site

    Langhorne, Pennsylvania, 19047

  • Study site

    Lansing, Michigan, 48909

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Layton, Utah, 84041

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Lexington, Tennessee, 38351

  • Study site

    Libertyville, Illinois, 60048

  • Study site

    Limerick, Pennsylvania, 19468

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    Linden, New Jersey, 07036

  • Study site

    Little Rock, Arkansas, 72204

  • Study site

    Littleton, Colorado, 80120

  • Study site

    Liverpool, New York, 13088

  • Study site

    Loma Linda, California, 92354

  • Study site

    Lomita, California, 90717

  • Study site

    Long Beach, California, 90822

  • Study site

    Los Alamitos, California, 90720

  • Study site

    Los Angeles, California, 90015

  • Study site

    Los Angeles, California, 90034

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Angeles, California, 90048

  • Study site

    Los Banos, California, 93635

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Loveland, Colorado, 80538

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Madison, Wisconsin, 53713

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Manassas, Virginia, 20109

  • Study site

    Manchester, New Hampshire, 03102

  • Study site

    Mansfield, Ohio, 44827

  • Study site

    Marianna, Florida, 32446

  • Study site

    Marion, Ohio, 43302

  • Study site

    Marrero, Louisiana, 70072

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Mather, California, 95655

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Melrose Park, Illinois, 60160

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Merrillville, Indiana, 46410

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33137

  • Study site

    Miami, Florida, 33186

  • Study site

    Middletown, Ohio, 45005

  • Study site

    Midland, Michigan, 48670

  • Study site

    Midlothian, Virginia, 23114

  • Study site

    Midwest City, Oklahoma, 73110

  • Study site

    Milwaukee, Michigan, 53295

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53226

Other trials in United States

Canada69 sites

  • Study site

    Ajax, Ontario, L1S 7K8

  • Study site

    Brampton, Ontario, L6Z 4N5

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Calgary, Alberta, T2E 7C5

  • Study site

    Cambridge, Ontario, N1R 6V6

  • Study site

    Cambridge, Ontario, N1R 7R1

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Edmonton, Alberta, T6K 4C1

  • Study site

    Gatineau, Quebec, J8Y 6S9

  • Study site

    Granby, Quebec, J2G 8Z9

  • Study site

    Greater Sudbury, Ontario, P3E 2N8

  • Study site

    Greater Sudbury, Ontario, P3E 3B8

  • Study site

    Greenfield Park, Quebec, J4V 2G8

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kingston, Ontario, K7L 5G2

  • Study site

    Kitchener, Ontario, N2H5Z8

  • Study site

    Kitchener, Ontario, N2M 5N4

  • Study site

    Lachine, Quebec, H8S 2E4

  • Study site

    Laval, Quebec, H7M 3L9

  • Study site

    Longueuil, Quebec, J4M 2X1

  • Study site

    Mississauga, Ontario, L5B 2P7

  • Study site

    Moncton, New Brunswick, E1G 1A7

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H2K 4L5

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Study site

    Nanaimo, British Columbia, V9R 3G9

  • Study site

    New Westminster, British Columbia, V3L 3W4

  • Study site

    Newmarket, Ontario, L3Y 8C3

  • Study site

    Oshawa, Ontario, L1J 2J9

  • Study site

    Ottawa, Ontario, K1Y 4W7

  • Study site

    Québec, Quebec, G1J 1Z4

  • Study site

    Québec, Quebec, G1R 2J6

  • Study site

    Québec, Quebec, G1V 4M6

  • Study site

    Saint Georges-de-beauce, Quebec, G5Y 4T8

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Saint-Lambert, Quebec, J4P 2H4

  • Study site

    Saint-Léonard, Quebec, H1S 3A9

  • Study site

    Saskatoon, Saskatchewan, S7K 0H6

  • Study site

    Sherbrooke, Quebec, J1H 4J6

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Sherbrooke, Quebec, J1J 2E3

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • Study site

    St. John's, Newfoundland and Labrador, A1E 2E2

  • Study site

    Ste. Foy, Quebec, G1V 4G5

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Terrebonne, Quebec, J6V 2H2

  • Study site

    Thunder Bay, Ontario, P7B 2Z3

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5B 1W8

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Trois-Rivières, Quebec, G8T 7A1

  • Study site

    Trois-Rivières, Quebec, G8Z 4K4

  • Study site

    Val-d'Or, Quebec, J9P 3Y1

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Victoria, British Columbia, V8R 4R2

  • Study site

    Westmount, Quebec, H3Z 2M6

  • Study site

    Winnipeg, Manitoba, R2H 2A6

  • Study site

    Winnipeg, Manitoba, R8A 1R9

Other trials in Canada

Netherlands44 sites

  • Study site

    's-Hertogenbosch, 5223 GZ

  • Study site

    Alkmaar, 1815 JD

  • Study site

    Almelo, 7609 PP

  • Study site

    Amersfoort, 3818 ES

  • Study site

    Amstelveen, 1186 AH

  • Study site

    Amsterdam, 1061 AE

  • Study site

    Amsterdam, 1066 EC

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam, 1091 AC

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Arnhem, 6815 AD

  • Study site

    Blaricum, 1261 AN

  • Study site

    Breda, 4818 CK

  • Study site

    Capelle AD Yssel, 2906 ZC

  • Study site

    Delft, 2625 AD

  • Study site

    Den Helder, 1782GZ

  • Study site

    Deventer, 7415 CM

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Enschede, 7512 KZ

  • Study site

    Goes, 4462 RA

  • Study site

    Groningen, 9728 NZ

  • Study site

    Haarlem, 2035 RC

  • Study site

    Heerlen, 6419 PC

  • Study site

    Hengelo, 7555 DL

  • Study site

    Hilversum, 1213 HX

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Hoorn, 1625 HV

  • Study site

    Leiden, 2300 RC

  • Study site

    Leiderdorp, 2353 GA

  • Study site

    Maastricht, 6202 AZ

  • Study site

    Nieuwegein, 3430 EM

  • Study site

    Nijmegen, 6532 SZ

  • Study site

    Purmerend, 1441 RN

  • Study site

    Rotterdam, 3045 PM

  • Study site

    Rotterdam, 3075 EA

  • Study site

    Rotterdam, 3083 AN

  • Study site

    Sneek, 8601 ZK

  • Study site

    Stadskanaal, 9501 HE

  • Study site

    Tilburg, 5022 GC

  • Study site

    Tilburg, 5042 AD

  • Study site

    Utrecht, 3584 CX

  • Study site

    Weert, 6001 BE

  • Study site

    Zaandam, 1502 DV

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Poland41 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-435

  • Study site

    Bydgoszcz, 85-826

  • Study site

    Elblag, 82-300

  • Study site

    Gdansk, 80-211

  • Study site

    Gdynia, 81-402

  • Study site

    Gdynia, 81-472

  • Study site

    Grodzisk Mazowiecki, 05-825

  • Study site

    Inowrocław, 88-100

  • Study site

    Katowice, 40-635

  • Study site

    Krakow, 30-069

  • Study site

    Krakow, 31-202

  • Study site

    Lodz, 91-425

  • Study site

    Lodz, 93-113

  • Study site

    Lublin, 20-089

  • Study site

    Nowa Sól, 67-100

  • Study site

    Płock, 09-400

  • Study site

    Poznan, 61-833

  • Study site

    Poznan, 61-848

  • Study site

    Puławy, 24-100

  • Study site

    Ruda Śląska, 41-703

  • Study site

    Siedlce, 08-110

  • Study site

    Sopot, 81-717

  • Study site

    Sosnowiec, 41-200

  • Study site

    Stalowa Wola, 37-450

  • Study site

    Starachowice, 27-200

  • Study site

    Świdnik, 21-040

  • Study site

    Szczecin, 70-111

  • Study site

    Tarnów, 33-100

  • Study site

    Torun, 87-100

  • Study site

    Wałbrzych, 58-309

  • Study site

    Warsaw, 00-217

  • Study site

    Warsaw, 02-507

  • Study site

    Warsaw, 02-637

  • Study site

    Warsaw, 03-242

  • Study site

    Warsaw, 96-100

  • Study site

    Wroclaw, 50-159

  • Study site

    Wroclaw, 50-420

  • Study site

    Wroclaw, 50-981

  • Study site

    Zamość, 22-400

  • Study site

    Zielona Góra, 65-046

Other trials in Poland

Brazil39 sites

  • Study site

    Aracaju, Sergipe, 49015400

  • Study site

    Belo Horizonte, Minas Gerais, 30110-068

  • Study site

    Belo Horizonte, Minas Gerais, 30140092

  • Study site

    Belo Horizonte, Minas Gerais, 30190-081

  • Study site

    Belo Horizonte, Minas Gerais, 30190-130

  • Study site

    Belo Horizonte, Minas Gerais, 31110-580

  • Study site

    Campina Grande do Sul, Paraná, 83430-000

  • Study site

    Campinas, São Paulo, 13060-803

  • Study site

    Campo Grande, Mato Grosso do Sul, 79070900

  • Study site

    Curitiba, Paraná, 80220-000

  • Study site

    Curitiba, Paraná, 80730150

  • Study site

    Fortaleza, Ceará, 60840285

  • Study site

    Goiânia, Goiás, 74223-130

  • Study site

    Maceió, Alagoas, 57051500

  • Study site

    Natal, Rio Grande do Norte, 59020-100

  • Study site

    Olinda, Pernambuco, 53030-010

  • Study site

    Pelotas, Rio Grande do Sul, 96015-290

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Study site

    Recife, Pernambuco, 50100-060

  • Study site

    Recife, Pernambuco, 52051-380

  • Study site

    Ribeirão Preto, São Paulo, 14048-900

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20221903

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20551030

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22240-006

  • Study site

    Salvador, Estado de Bahia, 40140000

  • Study site

    Santo André, São Paulo, 9190610

  • Study site

    Sao Jose Do Rio Preto, Santa Catarina, 15015-210

  • Study site

    Sao Jose Do Rio Preto, Santa Catarina, 15015205

  • Study site

    São José do Rio Preto, São Paulo, 15090-000

  • Study site

    São Paulo, São Paulo, 01323-020

  • Study site

    São Paulo, São Paulo, 01323-030

  • Study site

    São Paulo, São Paulo, 04012909

  • Study site

    São Paulo, São Paulo, 05403-000

  • Study site

    São Paulo, São Paulo, 22793-080

  • Study site

    Uberlândia, Minas Gerais, 38400-368

Other trials in Brazil

Argentina38 sites

  • Study site

    Almirante Brown, B1846DSK

  • Study site

    Bahía Blanca, B8000ILD

  • Study site

    Buenos Aires, 1039

  • Study site

    Buenos Aires, 1428

  • Study site

    Buenos Aires, 1431

  • Study site

    Buenos Aires, 1708

  • Study site

    Buenos Aires, 1722

  • Study site

    Buenos Aires, B1605DSX

  • Study site

    Buenos Aires, B2800JIR

  • Study site

    Buenos Aires, B7600FZN

  • Study site

    Buenos Aires, C1426ANZ

  • Study site

    Buenos Aires, C1437JCP

  • Study site

    Buenos Aires

  • Study site

    CABA, C1428DCO

  • Study site

    Capital Federal, C1093AAS

  • Study site

    Cipolletti, 8324

  • Study site

    Ciudad Autonoma Bs As, C1280AEB

  • Study site

    Ciudad Autónoma de Bs. As., C1437BZK

  • Study site

    Córdoba, 5016

  • Study site

    Córdoba, X5000AAC

  • Study site

    Córdoba, X5000JHQ

  • Study site

    Coronel Suárez, B7540GDH

  • Study site

    Corrientes, W3400AMZ

  • Study site

    Junín, B6000CMF

  • Study site

    La Plata, 1725

  • Study site

    Mar del Plata, 7600

  • Study site

    Mar del Plata, B7600FEN

  • Study site

    Mendoza, 5500

  • Study site

    Quilmes, 1878

  • Study site

    Rosario, 2000

  • Study site

    Rosario, S2000CVD

  • Study site

    Salta, A4406CLA

  • Study site

    San Isidro, B1642AKG

  • Study site

    San Justo, 1754

  • Study site

    San Martin, 1650

  • Study site

    San Miguel de Tucumán, 4000

  • Study site

    San Salvador de Jujuy, Y4600ABF

  • Study site

    Santa Fe, 3000

Other trials in Argentina

Germany38 sites

  • Study site

    Bad Krozingen, 79189

  • Study site

    Bad Rothenfelde, 49124

  • Study site

    Bad Segeberg, 23795

  • Study site

    Berlin, 10115

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 10249

  • Study site

    Berlin, 12157

  • Study site

    Berlin, 12559

  • Study site

    Berlin, 13353

  • Study site

    Berlin, 14050

  • Study site

    Bielefeld, 33604

  • Study site

    Bochum, 44787

  • Study site

    Bochum, 44789

  • Study site

    Burg, 03096

  • Study site

    Coburg, 96450

  • Study site

    Darmstadt, 64283

  • Study site

    Dortmund, 44137

  • Study site

    Duisburg, 47137

  • Study site

    Essen, 45122

  • Study site

    Frankfurt, 65929

  • Study site

    Frankfurt am Main, 60594

  • Study site

    Führt, 90766

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20099

  • Study site

    Heidelberg, 69120

  • Study site

    Homburg/Saar, 66421

  • Study site

    Langen, 63225

  • Study site

    Limburg, 65552

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68167

  • Study site

    Mönchengladbach, 41063

  • Study site

    Neuss, 41464

  • Study site

    Northeim, 37154

  • Study site

    Rüdersdorf, 15562

  • Study site

    Ulm, 89081

  • Study site

    Villingen-Schwenningen, 78048

  • Study site

    Witten, 58455

  • Study site

    Wuppertal, 42117

Other trials in Germany

China36 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100034

  • Study site

    Beijing, 100037

  • Study site

    Beijing, 100044

  • Study site

    Beijing, 100088

  • Study site

    Beijing, 100101

  • Study site

    Beijing, 10029

  • Study site

    Changsha, 410013

  • Study site

    Dalian, 116027

  • Study site

    Daqing, 163001

  • Study site

    Guangzhou, 510120

  • Study site

    Guangzhou

  • Study site

    Hangzhou, 310003

  • Study site

    Hangzhou, 310009

  • Study site

    Hangzhou, 310016

  • Study site

    Harbin, 150086

  • Study site

    Jinan, 250033

  • Study site

    Lanzhou, 730000

  • Study site

    Lanzhou, 730030

  • Study site

    Nanchang, 330006

  • Study site

    Nanjing, 210029

  • Study site

    Nanjing, 210036

  • Study site

    Shanghai, 200003

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200065

  • Study site

    Shanghai, 200233

  • Study site

    Shenyang, 110004

  • Study site

    Shenyang, 110016

  • Study site

    Shijiazhuang, 05000

  • Study site

    Shijiazhuang, 050082

  • Study site

    Suzhou, 215004

  • Study site

    Suzhou, 215006

  • Study site

    Wenzhou, 325000

  • Study site

    Wuhan, 430060

  • Study site

    Wuhan, 430071

  • Study site

    Xi'an, 710061

Other trials in China

United Kingdom27 sites

  • Study site

    Airdrie, ML6 0JS

  • Study site

    Barnet, EN5 3DJ

  • Study site

    Belfast, BT47 6SB

  • Study site

    Birmingham, B18 7QH

  • Study site

    Birmingham, B75 7RR

  • Study site

    Blackpool, FY3 8NR

  • Study site

    Bradford, BD9 6RJ

  • Study site

    Cambridge, CB1 8RN

  • Study site

    Chertsey, KT16 0PZ

  • Study site

    Edinburgh, EH16 4SB

  • Study site

    Glasgow, G11 6NK

  • Study site

    Glasgow, G31 2ER

  • Study site

    Glasgow, G51 4TF

  • Study site

    Larbert, FK5 4WR

  • Study site

    Leicester, LE3 9QP

  • Study site

    London, E11 1NR

  • Study site

    London, EC1M 6BQ

  • Study site

    Luton, LU4 0DZ

  • Study site

    Manchester, M13 9WL

  • Study site

    Middlesbrough, TS4 3BW

  • Study site

    Middlesex, UB1 3HW

  • Study site

    Nottingham, NG5 1PB

  • Study site

    Nuneaton, CV10 7DJ

  • Study site

    Paisley, PA2 9PN

  • Study site

    Peterborough, PE3 6DA

  • Study site

    Stockport, SK2 7JE

  • Study site

    Swansea, SA6 6NL

Other trials in United Kingdom

Czechia23 sites

  • Study site

    Brno, 656 91

  • Study site

    České Budějovice, 370 87

  • Study site

    Chrudim, 537 25

  • Study site

    Hradec Králové, 500 05

  • Study site

    Jihlava, 586 01

  • Study site

    Jindřichův Hradec, 377 38

  • Study site

    Karlovy Vary, 36066

  • Study site

    Kroměříž, 761 01

  • Study site

    Náchod, 547 01

  • Study site

    Ostrava - Fifejdy, 72880

  • Study site

    Pardubice, 53002

  • Study site

    Prague, 100 34

  • Study site

    Prague, 128 08

  • Study site

    Prague, 140 21

  • Study site

    Prague, 150 30

  • Study site

    Prague, 169 02

  • Study site

    Semily, 513 31

  • Study site

    Slaný, 274 01

  • Study site

    Tábor, 390 03

  • Study site

    Teplice, 415 01

  • Study site

    Trutnov, 541 01

  • Study site

    Zlín, 762 75

  • Study site

    Znojmo, 669 02

Other trials in Czechia

France22 sites

  • Study site

    Angers, 49033

  • Study site

    Bron, 69677

  • Study site

    Colmar, 68003

  • Study site

    Dijon, 21034

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13285

  • Study site

    Marseille, 13385

  • Study site

    Montfermeil, 93370

  • Study site

    Paris, 75475

  • Study site

    Paris, 75571

  • Study site

    Paris, 75674

  • Study site

    Paris, 75877

  • Study site

    Paris, 75908

  • Study site

    Pessac, 33604

  • Study site

    Poitiers, 86021

  • Study site

    Roubaix, 59056

  • Study site

    Saint-Herblain, 44800

  • Study site

    Strasbourg, 67010

  • Study site

    Strasbourg, 67091

  • Study site

    Tourcoing, 59208

  • Study site

    Valenciennes, 59322

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Israel22 sites

  • Study site

    Afula, 18101

  • Study site

    Beersheba, 84101

  • Study site

    Giv‘atayim, 53583

  • Study site

    Hadera, 38100

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 3109601

  • Study site

    Haifa, 31096

  • Study site

    Haifa, 34362

  • Study site

    Jerusalem, 91031

  • Study site

    Jerusalem, 91120

  • Study site

    Jerusalem, 91240

  • Study site

    Kfar Saba, 44281

  • Study site

    Nahariya, 22100

  • Study site

    Nazareth, 16100

  • Study site

    Petah Tikva, 49100

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tel Aviv, 64239

  • Study site

    Tel HaShomer, 52661

  • Study site

    Tiberias, 15208

  • Study site

    Tsrifin, 70300

Other trials in Israel

Italy22 sites

  • Study site

    Bergamo, Lombardy, 24128

  • Study site

    Carpi, Emilia-Romagna, 41012

  • Study site

    Caserta, Campania, 81100

  • Study site

    Castelnuovo, Tuscany, 55032

  • Study site

    Chieti, Abruzzo, 66100

  • Study site

    Como, Lombardy, 22020

  • Study site

    Forlì, Emilia-Romagna, 47100

  • Study site

    Genoa, Liguria, 16128

  • Study site

    Milan, Lombardy, 20138

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Naples, Campania, 80131

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Pesaro, The Marches, 61100

  • Study site

    Piacenza, Emilia-Romagna, 29100

  • Study site

    Rome, Lazio, 00152

  • Study site

    Rome, Lazio, 00184

  • Study site

    Rozzano, Lombardy, 20089

  • Study site

    S. Bonifacio, Veneto, 37047

  • Study site

    Treviso, Veneto, 31100

  • Study site

    Turin, Piedmont, 10126

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Spain22 sites

  • Study site

    Alicante, 03010

  • Study site

    Almería, 04009

  • Study site

    Barcelona, 08003

  • Study site

    Figueres, Girona, 17600

  • Study site

    Guadalajara, 19002

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Lugo, 27004

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28046

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Sant Joan d'Alacant, Alicante, 3550

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Santiago de Compostela, LA Coruña, 15706

  • Study site

    Seville, Sevilla, 41071

  • Study site

    Tarragona, 43007

  • Study site

    Valencia, 46014

  • Study site

    Valladolid, 47005

  • Study site

    Vigo, Pontevedra, 36214

  • Study site

    Vitoria-Gasteiz, Alava, 01006

Other trials in Spain

Hungary18 sites

  • Study site

    Baja, 6500

  • Study site

    Békéscsaba, 5600

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1096

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1115

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1135

  • Study site

    Budapest, H - 1041

  • Study site

    Debrecen, 4032

  • Study site

    Kalocsa, 6300

  • Study site

    Kecskemét, 6000

  • Study site

    Pécs, 7624

  • Study site

    Sopron, 9400

  • Study site

    Szeged, 6720

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szekszárd, 7100

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Australia16 sites

  • Study site

    Bedford Park, South Australia, 5042

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Cairns, Queensland, 4870

  • Study site

    Chermside, Queensland, 4032

  • Study site

    Coffs Harbour, New South Wales, 2450

  • Study site

    Concord, New South Wales, 2137

  • Study site

    Epping, New South Wales, 3076

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Joondalup, Western Australia, 6027

  • Study site

    Kingswood, New South Wales, 2747

  • Study site

    Milton, Queensland, 4064

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Sale, Victoria, 3850

  • Study site

    Wollongong, New South Wales, 2500

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea15 sites

  • Study site

    Busan, 602-715

  • Study site

    Daegu, 700-712

  • Study site

    Daegu, 705-717

  • Study site

    Gangwon-do, 24289

  • Study site

    Gangwon-Do, 200-704

  • Study site

    Gwangju, 61469

  • Study site

    Gyeonggi-do, 10380

  • Study site

    Gyeonggi-do, 10475

  • Study site

    Incheon, 405-760

  • Study site

    Kyonggi-do, 411-719

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 134-791

  • Study site

    Seoul, 140-73

  • Study site

    Seoul, 156-707

Other trials in South Korea

South Africa14 sites

  • Study site

    Alberton, 1449

  • Study site

    Bloemfontein, 9301

  • Study site

    Boksburg, 1459

  • Study site

    Durban, 4001

  • Study site

    Durban, 4091

  • Study site

    Johannesburg, 2000

  • Study site

    Johannesburg, 2013

  • Study site

    Johannesburg, 2157

  • Study site

    Kuilsriver, 7580

  • Study site

    Lyttelton, Pretoria, 0157

  • Study site

    Panorama, 7500

  • Study site

    Pinelands, 7405

  • Study site

    Pretoria, 0040

  • Study site

    Somerset West, 7130

Other trials in South Africa

Denmark10 sites

  • Study site

    Frederiksberg, 2000

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Herning, 7400

  • Study site

    Hillerød, 3400

  • Study site

    København S, 2300

  • Study site

    Køge, 4600

  • Study site

    Kolding, 6000

  • Study site

    Roskilde, 4000

  • Study site

    Svendborg, 5700

Other trials in Denmark

Belgium9 sites

  • Study site

    Aalst, 9300

  • Study site

    Bruges, 8000

  • Study site

    Brussels, 1180

  • Study site

    Brussels, 1200

  • Study site

    Genk, 3600

  • Study site

    Ghent, 9000

  • Study site

    La Louvière, 7100

  • Study site

    Roeselare, 8800

  • Study site

    Tienen, 3300

Other trials in Belgium

Slovakia9 sites

  • Study site

    Banská Bystrica, 974 01

  • Study site

    Bardejov, 08501

  • Study site

    Bratislava, 813 69

  • Study site

    Bratislava, 826 06

  • Study site

    Dolný Kubín, 02601

  • Study site

    Martin, 036 59

  • Study site

    Nitra, 949 01

  • Study site

    Rimavská Sobota, 979 01

  • Study site

    Žilina, 012 07

Other trials in Slovakia

New Zealand8 sites

  • Study site

    Auckland, 1023

  • Study site

    Auckland

  • Study site

    Christchurch, 8011

  • Study site

    Dunedin

  • Study site

    Hamilton, 3240

  • Study site

    Nelson, 7001

  • Study site

    New Plymouth, 4620

  • Study site

    Wellington, 6012

Other trials in New Zealand

Puerto Rico8 sites

  • Study site

    Aguas Buenas, 00703

  • Study site

    Caguas, 00725

  • Study site

    Manati, 00674

  • Study site

    Ponce, 00716

  • Study site

    Ponce, 00717

  • Study site

    Rio Grande, 00745

  • Study site

    San Juan, 00921

  • Study site

    Toa Baja, 00949

Other trials in Puerto Rico

Austria7 sites

  • Study site

    Feldkirch, 6807

  • Study site

    Graz, 8020

  • Study site

    Graz, 8036

  • Study site

    Linz, 4010

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1100

  • Study site

    Vienna, 1140

Other trials in Austria

Switzerland7 sites

  • Study site

    Fribourg, 1708

  • Study site

    Geneva, 1211

  • Study site

    Kreuzlingen, 8280

  • Study site

    Lucerne, 6000

  • Study site

    Lugano, 6900

  • Study site

    Münsterlingen, 8596

  • Study site

    Wolhusen, 6110

Other trials in Switzerland

Sweden5 sites

  • Study site

    Falun, 79182

  • Study site

    Gothenburg, 416 85

  • Study site

    Stockholm, 11883

  • Study site

    Stockholm, 18288

  • Study site

    Västerås, 72189

Other trials in Sweden

Finland3 sites

  • Study site

    Jyväskylä, 40620

  • Study site

    Kotka, 48100

  • Study site

    Kuopio, 70211

Other trials in Finland

Ireland3 sites

  • Study site

    Dublin, 7

  • Study site

    Dublin, 8

  • Study site

    Dublin, 9

Other trials in Ireland

Grenada1 site

  • Study site

    Toulouse, 31059

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Being tested
Dalcetrapib (RO4607381), Evidence-based medical care for Acute Coronary Syndrome, Placebo
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dalcetrapib (RO4607381)Drug

    600mg po daily

  • Evidence-based medical care for Acute Coronary SyndromeDrug

    As prescribed

  • PlaceboDrug

    po daily

Study groups in NCT00658515
Study groupRoleWhat they receive
Dalcetrapib (RO4607381)ExperimentalNot described
Receives: Drug: Dalcetrapib (RO4607381); Drug: Evidence-based medical care for Acute Coronary Syndrome
PlaceboPlacebo comparatorNot described
Receives: Drug: Evidence-based medical care for Acute Coronary Syndrome; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Cardiovascular Mortality and Morbidity

    Number of cardiovascular events per patient per year

    Measured: From date of randomization to first event up to 48 months

Secondary outcomes (3)

  1. Composite Endpoint:All Cause Mortality

    Measured: Throughout Study, up to 53 Months

  2. Change From Baseline for HDL Cholesterol

    Measured: At 53 Months

  3. Adverse Events, Lab Parameters, Vital Signs, ECG

    Measured: Throughout Study, up to 53 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15,871 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00658515
Sponsor's protocol ID
NC20971
Other IDs
2007-005103-18
Status last verified
Dec 2019
First submitted
28 Mar 2008
Last updated
3 Jan 2020

Publications

  • Schwartz GG, Leiter LA, Ballantyne CM, Barter PJ, Black DM, Kallend D, Laghrissi-Thode F, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Preiss D, Shah PK, Tardif JC, Kittelson J. Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease. Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6.

    PubMed 32144166

  • Salahuddin T, Kittelson J, Tardif JC, Shah PK, Olsson AG, Nicholls SJ, Leitersdorf E, Leiter LA, Kallend D, Black DM, Barter PJ, Ballantyne CM, Schwartz GG. Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial. Am Heart J. 2020 Mar;221:60-66. doi: 10.1016/j.ahj.2019.12.003. Epub 2019 Dec 16.

    PubMed 31927126

  • Schwartz GG, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Shah PK, Tardif JC, Kittelson J. Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):164-168. doi: 10.1001/jamacardio.2017.3833.

    PubMed 29071331

  • Pitts R, Gunzburger E, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, Nicholls SJ, Shah PK, Tardif JC, Olsson AG, McMurray JJ, Kittelson J, Schwartz GG. Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure. J Am Heart Assoc. 2017 Jan 10;6(1):e004119. doi: 10.1161/JAHA.116.004119.

    PubMed 28073769

  • Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.

    PubMed 27418594

  • Schwartz GG, Abt M, Bao W, DeMicco D, Kallend D, Miller M, Mundl H, Olsson AG. Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol. 2015 Jun 2;65(21):2267-75. doi: 10.1016/j.jacc.2015.03.544.

    PubMed 26022813

  • Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.

    PubMed 25583994

  • Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS; dal-OUTCOMES Investigators. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5.

    PubMed 23126252

  • Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

    PubMed 22345126

  • Derks M, Abt M, Parr G, Meneses-Lorente G, Young AM, Phelan M. No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opin Investig Drugs. 2010 Oct;19(10):1135-45. doi: 10.1517/13543784.2010.509342.

    PubMed 20738227

  • Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J; dal-OUTCOMES Committees and Investigators. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017.

    PubMed 19958854

  • Stein EA, Stroes ES, Steiner G, Buckley BM, Capponi AM, Burgess T, Niesor EJ, Kallend D, Kastelein JJ. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 Jul 1;104(1):82-91. doi: 10.1016/j.amjcard.2009.02.061.

    PubMed 19576325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dalcetrapib (RO4607381) and Evidence-based medical care for Acute Coronary Syndrome in people with Coronary Heart Disease, run by Hoffmann-La Roche at 1,089 sites in 29 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 4 inclusion and 5 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,089 sites in United States, Canada, Netherlands, Poland, Brazil and 24 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 3 Jan 2020). 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?

Incidence of Cardiovascular Mortality and Morbidity (time frame: From date of randomization to first event up to 48 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 NCT00658515, which also lists 12 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 3 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in