DyslipidemiaPhase 3FOURIER OLENCT02867813

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

A Phase 3 study testing Evolocumab in people with Dyslipidemia, run by Amgen at 198 sites in 7 countries.

Completed

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

Trial summary

The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD). Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Dyslipidemia
What is being tested?: Evolocumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,035 participants
Where: 198 sitesin 7 countries
Study dates: 2 Sep 2016to 21 Mar 2022
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has provided informed consent before initiation of any study-specific activities/procedures
Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.

Who cannot join

Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded

Trial locations and contacts

198 sites in 7 countries.

Country

City, postcode or hospital

198 sites in 7 countries

United States144 sites

Research Site
Addison, Illinois, 60101
Research Site
Athens, Georgia, 30606
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Atlanta, Georgia, 30342
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Auburn, Maine, 04210
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Augusta, Georgia, 30909
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Aurora, Colorado, 80012
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Austin, Texas, 78758
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Baltimore, Maryland, 21204
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Bangor, Maine, 04401
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Banning, California, 92220
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Belleville, Illinois, 62220
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Biddeford, Maine, 04005
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Birmingham, Alabama, 35294
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Boynton Beach, Florida, 33472
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Brooklyn, New York, 11206
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Burke, Virginia, 22015
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Calabash, North Carolina, 28467
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Camp Hill, Pennsylvania, 17011
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Canton, Ohio, 44710
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Chambersburg, Pennsylvania, 17201
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Charleston, South Carolina, 29407
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Charlotte, North Carolina, 28204
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Chicago, Illinois, 60616
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Cincinnati, Ohio, 45219
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Clearwater, Florida, 33756
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Coeur d'Alene, Idaho, 83814
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Colorado Springs, Colorado, 80909
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Columbia, Maryland, 21044
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Columbus, Ohio, 43201
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Columbus, Ohio, 43215
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Cortlandt Manor, New York, 10567
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Crystal River, Florida, 34429
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Dayton, Ohio, 45414
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Daytona Beach, Florida, 32117
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Denver, Colorado, 80218
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Dunwoody, Georgia, 30338
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Elyria, Ohio, 44035
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Evansville, Indiana, 47714
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Falls Church, Virginia, 22042
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Fargo, North Dakota, 58122
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Federal Way, Washington, 98003
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Gainesville, Georgia, 30501
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Germantown, Tennessee, 38138
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Grandville, Michigan, 49418
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Green Bay, Wisconsin, 54301
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Greensboro, North Carolina, 27408
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Hammond, Louisiana, 70403
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Haverhill, Massachusetts, 01830
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Hickory, North Carolina, 28601
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High Point, North Carolina, 27262
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Hollywood, Florida, 33021
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Hollywood, Florida, 33024
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Houston, Texas, 77025
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32216
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Jerseyville, Illinois, 62052
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Kalispell, Montana, 59901
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64128
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Kerrville, Texas, 78028
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Lansing, Michigan, 48912
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Largo, Florida, 33777
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Las Vegas, Nevada, 89148
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Layton, Utah, 84041
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Lexington, Kentucky, 40503
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Lincoln, Nebraska, 68506
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Littleton, Colorado, 80120
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Long Beach, California, 90807
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Marion, Ohio, 43302
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Memphis, Tennessee, 38104
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Meridian, Idaho, 83642
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Metairie, Louisiana, 70006
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Miami, Florida, 33173
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Moncks Corner, South Carolina, 29461
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Monroe, Louisiana, 71201
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Mooresville, North Carolina, 28117
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Munster, Indiana, 46321
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Muskegon, Michigan, 49444
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Nashville, Tennessee, 37203
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Natchitoches, Louisiana, 71457
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New Hyde Park, New York, 11042
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New Port Richey, Florida, 34653
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New Windsor, New York, 12553
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New York, New York, 10029
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Newton, Massachusetts, 02459
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North Myrtle Beach, South Carolina, 29582
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Oceanside, California, 92056
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Old Point Station, South Carolina, 29707
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Oxnard, California, 93030
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Palm Springs, California, 92262
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Pawtucket, Rhode Island, 02860
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Pensacola, Florida, 32501
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Philadelphia, Pennsylvania, 19152
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Phoenix, Arizona, 85018
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Pittsburgh, Pennsylvania, 15206
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Plano, Texas, 75023
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Plano, Texas, 75024
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Ponte Vedra Beach, Florida, 32081
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Port Charlotte, Florida, 33952
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Portland, Oregon, 97225
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Pryor, Oklahoma, 74361
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23294
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Rochester, New York, 14609
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Roseville, California, 95661
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Saginaw, Michigan, 48601
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Saint Cloud, Minnesota, 56303
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Saint Paul, Minnesota, 55102
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Salisbury, Maryland, 21804
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San Antonio, Texas, 78229
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San Diego, California, 92161
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San Pedro, California, 90732
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Sandusky, Ohio, 44870
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Sarasota, Florida, 34232
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Sarasota, Florida, 34239
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Savannah, Georgia, 31406
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Seattle, Washington, 98195
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Slidell, Louisiana, 70458
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Springfield, Ohio, 45505
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St Louis, Missouri, 63128
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St. Petersburg, Florida, 33713
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Statesville, North Carolina, 28625
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Suffolk, Virginia, 23435
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Suwanee, Georgia, 30024
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Tabor City, North Carolina, 28463
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Tarzana, California, 91356
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Toledo, Ohio, 43615
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Torrance, California, 90502
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74133
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Tupelo, Mississippi, 38801
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Valley Village, California, 91607
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Voorhees Township, New Jersey, 08043
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Waterloo, Iowa, 50702
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West Jordan, Utah, 84088
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West Seneca, New York, 14224
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Wichita, Kansas, 67203
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Wichita Falls, Texas, 76301
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Williamsville, New York, 14221
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Willoughby, Ohio, 44094
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Wilmington, North Carolina, 28401
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Winston-Salem, North Carolina, 27103

Other trials in United States

Poland31 sites

Research Site
Bielsko-Biala, 43-316
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Bydgoszcz, 85-094
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Gdansk, 80-542
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Gdynia, 81-402
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Gdynia, 81-472
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Giżycko, 11-500
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Katowice, 40-084
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Kielce, 25-020
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Krakow, 30-082
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Krakow, 31-202
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Krakow, 31-216
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Lodz, 91-347
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Lublin, 20-857
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Nysa, 48-300
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Olsztyn, 10-010
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Płock, 09-402
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Poznan, 61-853
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Pszczyna, 43-200
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Puławy, 24-100
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Ruda Śląska, 41-709
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Skierniewice, 96-100
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Staszów, 28-200
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Świdnik, 21-040
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Tarnów, 33-100
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Torun, 87-100
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Warsaw, 02-097
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Warsaw, 02-507
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Warsaw, 04-628
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Włocławek, 87-800
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Wroclaw, 50-349
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Zamość, 22-400

Other trials in Poland

Czechia12 sites

Research Site
Brno, 603 00
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Brno, 625 00
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Brno, 638 00
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Jihlava, 586 33
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Liberec, 460 63
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Mohelnice, 789 85
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Ostrava, 728 80
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Ostrava-Dubina, 700 30
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Prague, 128 08
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Přerov, 750 02
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Pribram VIII, 261 01
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Znojmo, 669 02

Other trials in Czechia

Russia5 sites

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Moscow, 129090
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Saint Petersburg, 192289
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Saint Petersburg, 197022
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Saint Petersburg, 199106
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Saratov, 410054

Other trials in Russia

Hungary3 sites

Research Site
Békéscsaba, 5600
Research Site
Miskolc, 3529
Research Site
Nyíregyháza, 4400

Other trials in Hungary

Slovakia2 sites

Research Site
Košice, 040 22
Research Site
Svidník, 089 01

Other trials in Slovakia

Ukraine1 site

Research Site
Zaporizhzhya, 69600

Other trials in Ukraine

About this study

Official title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease

The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).

Read the detailed description

This is a multicenter, open-label extension study designed to assess the long-term safety of evolocumab in subjects who completed the FOURIER study,which is a randomized placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of FOURIER study.

Conditions: Dyslipidemia
Being tested: Evolocumab
Keywords: High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Medical subject headings: Dyslipidemias, Hypercholesterolemia

What participants receive

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

EvolocumabBiological
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.

Study groups in NCT02867813
Study group	Role	What they receive
evolocumab (AMG 145)	Experimental	All subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference. Receives: Biological: Evolocumab

What is being measured

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

Number of Participants Who Experienced an Adverse Event
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Measured: Up to 5 years

Secondary outcomes (2)

Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Measured: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Measured: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

Timeline

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

2 Sep 201621 Mar 2022

First posted16 Aug 2016 (estimated)
Study start2 Sep 2016
Primary completion21 Mar 2022
Study completion21 Mar 2022

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 (2)Papers the sponsor has linked to this study.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
More trials run by AmgenThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5,035 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02867813
Sponsor's protocol ID: 20130295
Other IDs: 2015-004780-36, 2015
Acronym: FOURIER OLE
Status last verified: Mar 2023
First submitted: 20 Jul 2016
Last updated: 7 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
PubMed 36031810
Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
PubMed 36779348

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
ClinicalTrials.gov ID: NCT02867813
Acronym / sponsor ID: FOURIER OLE / 20130295
Conditions: Dyslipidemia
Keywords: High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,035 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 2 Sep 2016 (actual)
Primary completion: 21 Mar 2022 (actual)
Study completion: 21 Mar 2022 (actual)
First posted: 16 Aug 2016 (estimated)
Results: Posted 28 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
evolocumab (AMG 145)	Experimental	Biological: EvolocumabAll subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference.

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject has provided informed consent before initiation of any study-specific activities/procedures
Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.

Key exclusion criteria (7 listed)

Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing

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
Evolocumabsubjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.	Biological	evolocumab (AMG 145)

Primary outcome

Number of Participants Who Experienced an Adverse Event
Time frame: Up to 5 years
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.

2 secondary outcomes

Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Time frame: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Time frame: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

Results and safety

Results posted to the registry on 28 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study	2,535	2,084
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study	2,500	2,090

Primary outcome: Number of Participants Who Experienced an Adverse Event

Time frame: Up to 5 years. Count of participants. Unit: Participants

Measure	Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study n = 2532	Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study n = 2499
Value	2144	2084

Population analysed: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to approximately 5 years during the OLE study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo in Parent Study	1,077 of 2,532 (42.5%)	956 of 2,532 (37.8%)	309 of 2,535
Evolocumab in Parent Study	1,045 of 2,499 (41.8%)	959 of 2,499 (38.4%)	287 of 2,500

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36031810O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
Background: PubMed 36779348Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.

MD study director

Amgen

198 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab in people with Dyslipidemia, run by Amgen at 198 sites in 7 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 2 inclusion and 7 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, Poland, Czechia, Russia, Hungary and 2 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. 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 28 Feb 2023). 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?

Number of Participants Who Experienced an Adverse Event (time frame: Up to 5 years). 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 NCT02867813, which also lists 2 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 7 Apr 2023.