Atherosclerotic Cardiovascular DiseasePhase 3PREVAILNCT05202509
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
A Phase 3 study testing Obicetrapib in people with Atherosclerotic Cardiovascular Disease, run by NewAmsterdam Pharma at 591 sites in 23 countries.
Trial summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Obicetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,541 participants
- Where
- 591 sitesin 23 countries
- Study dates
- 7 Feb 2022to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males \& females ≥ 18 years age.
- Established ASCVD including:
- Coronary artery disease
- Cerebrovascular disease
- Peripheral Artery disease
- On maximally tolerated lipid-modifying therapy
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- Fasting LDL-C ≥ 55 mg/dL
- Fasting triglycerides < 400 mg/dL
- Estimated glomerular filtration rate ≥ 30 mL/min
Who cannot join
- New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%
- Have been hospitalized for Heart Failure within 5 years prior to screening
- Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
- Uncontrolled hypertension
- Diagnosis of homozygous familial hypercholesterolemia (HoFH)
- Active liver disease
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- HbA1c ≥10%
- Thyroid Stimulating Hormone (TSH) > 1.5 times upper limit normal
- Creatine kinase > 3 times upper limit normal
- History of malignancy with surgery in past 3 years
- History of alcohol or drug abuse within past 5 years
- Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine
- Known allergy to study drug
- Participated in previous obicetrapib trial
- Taking gemfibrozil within 30 days screening
Trial locations and contacts
591 sites in 23 countries.
591 sites in 23 countries
United States199 sites
Biofortis, Inc
Addison, Illinois, 60101
New Mexico Clinical Research & Osteoporosis Center Inc.
Albuquerque, New Mexico, 87106
Advanced Cardiovascular LLC
Alexander City, Alabama, 35010
Cambridge Medical Trials
Alexandria, Louisiana, 71301
PharmaTex Research, LLC
Amarillo, Texas, 79109
Advanced Research Center
Anaheim, California, 92805
Community Health Network-Anderson
Anderson, Indiana, 46011
Northwest Heart Clinical research
Arlington Heights, Illinois, 60005
Javara Inc - Wake Forest Health Network Family Physicians - Sunset Avenue
Asheboro, North Carolina, 27203
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Central Texas Clinical Research
Austin, Texas, 78705
Accelemed Research Institute
Austin, Texas, 78745
Northeast Cardiology Associates
Bangor, Maine, 04401
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211
Ascension - Cardiology Specialists of Birmingham
Birmingham, Alabama, 35205
Central Alabama Research
Birmingham, Alabama, 35209
Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, 35243
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
Advanced Heart Care, LLC
Bridgewater, New Jersey, 08807
Burke Internal Medicine & Research
Burke, Virginia, 22015
Hope Clinical Research LLC
Canoga Park, California, 91303
East Coast Institute for Research - Canton
Canton, Georgia, 30114
Cary Research Group, LLC
Cary, North Carolina, 27518
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Javara Inc - Tryon Medical Partners LLC
Charlotte, North Carolina, 28210
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, 37404
Javara Inc - Healthy Steps
Chevy Chase, Maryland, 20815
IMA Clinical Research, PC
Chicago, Illinois, 60602
Meridian Clinical Research - Cincinnati, OH
Cincinnati, Ohio, 45219
Meridian Clinical Research - Springfield, OH
Cincinnati, Ohio, 45246
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756
Innovative Research of West Florida
Clearwater, Florida, 33756
Alpine Research Organization, Inc.
Clinton, Utah, 84015
Private Practice - O. Alejandro Brusco, MD FACE PA
Corpus Christi, Texas, 78414
West Broadway Clinic
Council Bluffs, Iowa, 51501
Cardiovascular Associates Research, LLC - Covington, LA
Covington, Louisiana, 70433
Clinical Research Collaborative, LLC
Cumberland, Rhode Island, 02864
Atlanta Heart Specialists
Cumming, Georgia, 30084
Javara Inc - Bridge Creek Family Medicine
Cypress, Texas, 77433
Southwest Family Medicine Associates
Dallas, Texas, 75325
Texas Health Research & Education Institute
Dallas, Texas, 76107
PriMed Clinical Research
Dayton, Ohio, 45419
Avail Clinical Research
DeLand, Florida, 32720
The Iowa Clinic - Cardiovascular Services
Des Moines, Iowa, 50266
Physicians' Research Options (PRO)
Draper, Utah, 84020
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Alta Pharmaceutical Research Center
Dunwoody, Georgia, 30338
Cardiology Care Clinic of Lake Oconee
Eatonton, Georgia, 31024
South Texas Research Institute
Edinburg, Texas, 78539
David Turbay, MD, PLLC
El Paso, Texas, 79905
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, 46514
Titan Medical Research - Oceanside
Encinitas, California, 92024
Eastern Shore Research Institute, LLC
Fairhope, Alabama, 36532
Lillestol Research LLC
Fargo, North Dakota, 58104
Aa Mrc, Llc
Flint, Michigan, 48504
Invesclinic
Fort Lauderdale, Florida, 33308
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707
Javara Inc - Texas Health Care Family Physicians
Fort Worth, Texas, 76132
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164
Mt. Olympus Medical Research
Friendswood, Texas, 77546
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, 38138
Healthy Heart Cardiology
Grand Rapids, Michigan, 49564
Prevea Health
Green Bay, Wisconsin, 54303
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, 27401
Medication Management, LLC
Greensboro, North Carolina, 28210
Clinical Investigation Specialists
Gurnee, Illinois, 60031
Mass General Brigham Pentucket Medical Associates - Haverhill
Haverhill, Massachusetts, 01830
Apex Medical Research
Hazel Crest, Illinois, 60429
Qway Research
Hialeah, Florida, 33010
New Generation of Medical Research
Hialeah, Florida, 33016
Abington Medical Specialists, P.C. dba AMS Cardiolog
Horsham, Pennsylvania, 19044
East Texas Cardiology, PA
Houston, Texas, 77002
Angiocardiac Care of Texas
Houston, Texas, 77025
Texas Heart Institute
Houston, Texas, 77030
Southwest Clinical Trials
Houston, Texas, 77074
BioStar Clinical Research
Houston, Texas, 77094
Texas Center for Drug Development
Houston, Texas, 77375
The Heart Center Research
Huntsville, Alabama, 35801
Hutchinson Clinic
Hutchinson, Kansas, 67502
Medstar Health Research Institute
Hyattsville, Maryland, 20782
Community Health Network
Indianapolis, Indiana, 46227
East Coast Institute for Research
Jacksonville, Florida, 32086
East Coast Institute for Research - Jacksonville Monroe St
Jacksonville, Florida, 32204
East Coast Institute for Research - Jacksonville University Blvd
Jacksonville, Florida, 32216
East Coast Institute for Research - Perimeter Park Court
Jacksonville, Florida, 32216
NSC Research
Johns Creek, Georgia, 30024
NEA Baptist clinic
Jonesboro, Arkansas, 72405
West Houston Area Clinical Trial Consultants, LLC
Katy, Texas, 77493
Clinical Investigation Specialists
Kenosha, Wisconsin, 53144
Holston Medical Group
Kingsport, Tennessee, 37660
New Phase Research & Development
Knoxville, Tennessee, 37909
East Coast Institute for Research- Lake City
Lake City, Florida, 32055
Milton Haber, M.D
Laredo, Texas, 78041
Sierra Clinical Research
Las Vegas, Nevada, 89106
AB Clinical Trials
Las Vegas, Nevada, 89119
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Clinical Trials of America, LLC - Lenoir, NC
Lenoir, North Carolina, 28645
The Research Group of Lexington, LLC
Lexington, Kentucky, 40503
Nexgen Research
Lima, Ohio, 45805
Clinical Trials Research
Lincoln, California, 95648
Meridian Clinical Research- Lincoln, NE
Lincoln, Nebraska, 68510
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
Torrance Clinical Research Institute Inc.
Lomita, California, 90717
American Institute of Research
Los Angeles, California, 90211
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213
Carient Heart & Vascular
Manassas, Virginia, 20109
SV Research
Marion, Ohio, 43302
Advanced Medical Research (AMR)
Maumee, Ohio, 43537
ActivMed Practices and Research - Methuen
Methuen, Massachusetts, 01844
Columbus Clinical Services
Miami, Florida, 33125
Finlay Medical Research Corp
Miami, Florida, 33126
A+ Research Inc
Miami, Florida, 33144
Ezy Medical Research
Miami, Florida, 33175
ProLive Medical Research
Miami, Florida, 33175
Med Research of Florida, LLC
Miami, Florida, 33186
Montana Medical Research, Inc.
Missoula, Montana, 59808
Mobile Heart Specialists
Mobile, Alabama, 36608
Diabetes and Endocrinology Consultants, P.C
Morehead City, North Carolina, 28557
Burke Primary Care
Morganton, North Carolina, 28655
McLaren Macomb Regional Medical Center
Mount Clemens, Michigan, 48043
Inspira Medical Centers
Mullica Hill, New Jersey, 08302
ASHA Clinical Research - Munster, LLC
Munster, Indiana, 46321
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, 46321
Syed Research Consultants
Muscle Shoals, Alabama, 35661
New Generation of Medical Research - Naples
Naples, Florida, 34104
BTC of New Bedford
New Bedford, Massachusetts, 02740
Advanced Research Institute Inc
New Port Richey, Florida, 34653
Mid-Hudson Medical Research, PLLC - New Windsor
New Windsor, New York, 12553
IMA Clinical Research PC and Affiliates- New York, NY
New York, New York, 10036
York Clinical Research LLC
Norfolk, Virginia, 23510
Lynn Institute of Norman
Norman, Oklahoma, 73072
DiGiovanna Institute for Medical Education and Research
North Massapequa, New York, 11758-1802
North Hills Medical Research, Inc.
North Richland Hills, Texas, 76180
Amicis Research Center-Northridge
Northridge, California, 91324
Amicis Research
Northridge, California, 91324
Valley Clinical Trials, Inc
Northridge, California, 91325
Cardiology Associates of Fairfield County
Norwalk, Connecticut, 06905
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, 60657
Ocala Research Institute
Ocala, Florida, 34471
Lynn Health Science Institute - East
Oklahoma City, Oklahoma, 73111
South Carolina Clinical Research LLC
Orangeburg, South Carolina, 29118
Ormond Beach Clinical Research LLC
Ormond Beach, Florida, 32174
Research Integrity
Owensboro, Kentucky, 42303
Tapia Internal Medicine Clinic
Paris, Texas, 75460
Linq Research, LLC
Pearland, Texas, 60602
Elite Clinical Studies
Phoenix, Arizona, 85018
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, 28374
Preferred Primary Care Physicians Group - Pleasant Hills
Pittsburgh, Pennsylvania, 15236
Styde Research
Plano, Texas, 75093
Cardiovascular Research of Knoxville
Powell, Tennessee, 37849
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
Rapid City, South Dakota, 57701
Dominion Medical Associates
Richmond, Virginia, 23219
Advanced Cardiology Associates
Rochester Hills, Michigan, 49546
Optimal Research, LLC
Rockville, Maryland, 32763
Endocrine Research Solutions, Inc
Roswell, Georgia, 30076
Heart and Vascular Center at Methodist Hospital
Saint Louis Park, Minnesota, 55416
Wasatch Clinical Research
Salt Lake City, Utah, 84102
Sun Research Institute
San Antonio, Texas, 78215
San Antonio Premier Internal Medicine
San Antonio, Texas, 78220
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio, Texas, 78249
Headlands Research
Sarasota, Florida, 34243
Saratoga Clinical Research
Saratoga Springs, New York, 12866
Javara Inc - SouthCoast Health
Savannah, Georgia, 31406
Syed Research Consultants
Sheffield, Alabama, 35660
Sherman Clinical Research
Sherman, Texas, 75092
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681
Louisiana Heart Center
Slidell, Louisiana, 70458
Frontier Clinical Research
Smithfield, Pennsylvania, 15478
Cardio Metabolic Institute
Somerset, New Jersey, 08873
Revival Research Institute
Southgate, Michigan, 48195
IMA Clinical Research - St. Louis, MO
St Louis, Missouri, 63117
St. Louis Heart and Vascular Cardiology
St Louis, Missouri, 63136
Piedmont Healthcare - Statesville
Statesville, North Carolina, 28625
Stephenville Medical & Surgical Clinic
Stephenville, Texas, 76401
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona, 85375
Herman Clinical Research
Suwanee, Georgia, 30024
MultiCare Institute for Research and Innovation- Tacoma
Tacoma, Washington, 98405
Universal Research Group LLC
Tacoma, Washington, 98405
BayCare Health System
Tampa, Florida, 33614
JSV Clinical Research Study, Inc
Tampa, Florida, 33634
Chear Center LLC
The Bronx, New York, 10455
Javara Inc - Highland Woods Health
The Woodlands, Texas, 77382
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90502
Oakland Medical Research Center
Troy, Michigan, 48085
Arcturus Healthcare
Troy, Michigan, 48098
Eclipse Clinical Research
Tucson, Arizona, 85745
Meridian Clinical Research- Endwell, NY
Vestal, New York, 13760
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Clinical Trials of America
West Monroe, Louisiana, 71291
Southgate Medical Group
West Seneca, New York, 14224
Great Lakes Medical Research, LLC
Westfield, New York, 14787
Kansas Nephrology Research Institute
Wichita, Kansas, 67214
West Houston Area Clinical Trial Consultants
Wichita, Kansas, 67226
Wilmington Health Associates
Wilmington, North Carolina, 28412
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Clinical Research of Central Florida
Winter Haven, Florida, 33880
Penn State Health Medical Group- Berks Cardiology
Wyomissing, Pennsylvania, 19610
Michigan Heart
Ypsilanti, Michigan, 48197
Southern Clinical Research, LLC
Zachary, Louisiana, 70791
Poland48 sites
CENTRUM MEDYCZNE INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796
Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna
Bydgoszcz, 85231
DIAB Serwis Popenda Spólka Jawna
Chorzów, 41-500
NZOZ Twoje Zdrowie EL Sp. z o.o.
Elblag, 82-300
Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Adam Grzybowski
Gdansk, 80-262
Uniwersyteckie Centrum Kliniczne, I Klinika Kardiologii
Gdansk
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
Gdynia, 81-157
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki
Centrum Medyczne Pratia Katowice
Katowice, 40-081
SALVIA Lekston i Madej s.j.
Katowice, 40-675
Silmedic Sp. z o.o.
Katowice
Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska
Krakow, 30-082
Pratia MCM Krakow
Krakow, 30-510
Krakowski Szpital Specjalistyczny im. Jana Pawla II - Oddzial Kliniczny Kardiologii Interwencyjnej z Pododdzialem Intenyswengo Nadzoru Kardiologicznego
Krakow, 31-202
Centrum Medyczne ZDROWA
Krakow, 31-216
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501
ETG Lodz - Santa Sp. z. o.o.
Lodz, 90-302
FutureMeds Lodz
Lodz, 91-363
INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych
Lodz, 93-338
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
Lodz, 94-255
Clinical Best Solutions - Lublin
Lublin, 20-078
KO - MED Centra Kliniczne Lublin II
Lublin, 20-362
ETG Lublin - Pro Life Medica Sp. z o.o
Lublin, 20-412
Szpital Sw. Anny w Miechowie
Miechów, 32-086
Pomorskie Centra Kardiologiczne Sp. z o.o., SKA - Mragowo
Mrągowo
ZOZ w Olawie, Oddzial Chorob Wewnetrznych
Oława, 55-200
Futuremeds Olsztyn
Olsztyn, 10-010
Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik
Ostrowiec Świętokrzyski
Centrum Medyczne OMEDICA Jaroslaw Opiela i Beata Opiela s. j.
Poznan, 60-111
NZOZ Neuro-Kard - Ilkowski i Partnerzy Spólka Partnerska Lekarzy
Poznan, 61-853
Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia
Ruda Śląska, 41-710
ETG Siedlce- Lukmed 2 Sp. z o.o.
Siedlce, 08-110
ETG Skierniewice - ClinMedica Research Sp. z o.o.
Skierniewice, 96-100
NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych
Sopot, 81-423
Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
Staszów
Osrodek Badan Klinicznych LabMed Agnieszka Karczmarczyk, Filip Karczmarczyk Spólka Cywilna
Szczecin, 71-526
Prywatny Gabinet Lekarski Jacek Gessek
Torun, 87-100
FutureMeds Warszawa Centrum
Warsaw, 00-215
ETG Warszawa- MCM Polimedica 2 Sp. z o.o.
Warsaw, 02-793
FutureMeds Targowek
Warsaw, 03-291
Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
Warsaw
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Poradnia Prewencji i Leczenia Chorob Metabolicznych, Zaklad Epidemiologii, Prewencji Chorób Ukladu Krazeni
Warsaw
FutureMeds Sp. z o.o
Wroclaw, 50-088
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
Wroclaw, 50-981
Wroclawska Grupa Medyczna Pankiewicz Spolka Jawna
Wroclaw, 53-149
ETG Zamosc - Pro Life Medica Sp. z o.o
Zamość, 22 - 400
KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu
Zamość, 22-400
Bulgaria35 sites
MHAT Aytos EOOD Department of Internal Diseases
Aytos, 8500
Medical Center Doctor Staykov EOOD
Burgas, 8000
UMHAT Deva Maria
Burgas
Medical Center Viva Feniks
Dobrich, 9300
MHAT Sveti Ivan Rilski
Gorna Oryahovitsa, 5100
MHAT Haskovo AD
Haskovo, 6300
MHAT City Clinic - Sveti Georgi EOOD
Montana, 3400
Medical Center - Cordis OOD
Pleven, 5800
MHAT Heart and Brain Pleven
Pleven, 5800
Medical Center for Rehabilitation and Sports Medicine I - Plovdiv EOOD
Plovdiv, 4002
UMHAT Sveti Georgi EA
Plovdiv, 4002
Medical Center Rusemed EOOD
Rousse, 7000
SHATC Medica Cor EAD
Rousse, 7013
Multiprofile Hospital for Active Treatment (MHAT)- Silistra
Silistra
MHAT Dr. Ivan Seliminski AD
Sliven, 8800
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
Sofia, 1000
MHAT Sveta Sofia EOOD
Sofia, 1000
Diagnostic and Consulting Center 22 - Sofia
Sofia, 1113
DCC "Ascendent"
Sofia, 1202
Diagnostic consultative center 24
Sofia, 1231
National Multiprofile Transport Hospital Tsar Boris Treti - Cardiology Clinic
Sofia, 1233
Medical Centre Medcross
Sofia, 1309
Diagnostic Consulting Center Convex EOOD
Sofia, 1680
MC Doctor Kalchev OOD
Sofia, 1700
"Medical Center Medic" OOD
Sofia
Multiprofile Hospital for Active Treatment National Cardiology Hospital
Sofia
CardioArt Medical Center
Stara Zagora, 6000
Medical Center Zara - Med
Stara Zagora, 6003
UMHAT Prof. Dr. Stoyan Kirkovich
Stara Zagora, 6003
Diagnostic Consultative Center Chaika
Varna, 9000
Medical Center Plazmamed Clinic
Varna, 9000
Specialized Hospital for Active Treatment of Cardiology
Varna, 9020
Medical Center Medica Plus OOD
Veliko Tarnovo, 5006
Medical Center Nevromedics
Veliko Tarnovo
Medical Center Velingrad 2017 EOOD
Velingrad, 4600
Germany32 sites
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
Bad Homburg
kfgn | Site Operations & Services GmbH - Berlin-Mitte
Berlin, 10117
Franziskus Hospital Berlin
Berlin, 10787
Diabetespraxis Dr. Braun
Berlin, 13187
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
Bremen
MVZ am Küchwald GmbH
Chemnitz
Gemeinschaftspraxis Diabeteszentrum Dortmund
Dortmund
St Johannes Hospital Dortmund
Dortmund
Kfgn | Site Operations & Services GmbH - Dresden
Dresden, 1069
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden
ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH
Elsterwerda, 4910
Katholisches Krankenhaus St. Johann Nepomuk
Erfurt
Klinisches Forschungszentrum Dr. Hagemann
Essen
Studienzentrum Bocholderstrasse
Essen
Zentrum für Klinische Studien (diabetes-falkensee.de)
Falkensee
ClinPhenomics CVC GmbH
Frankfurt, 60596
Diabeteszentrum Hamburg West (DZHW) / Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
Hamburg
St. Josefskrankenhaus Heidelberg GmbH
Heidelberg, 69115
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Velocity Clinical Research Leipzig GmBH
Leipzig, 4103
Diabetologikum DDG Ludwigshafe
Ludwigshafen
Kliniken Maria Hilf GmbH Krankenhaus St. Franziskus
Mönchengladbach, 41063
CDG Studienambulanz Dr. Hartard
München
Klinikum München Klinik Neuperlach
München
Praxis Drs. Haggenmiller/Jeserich
Nuremberg
RED-Institut GmbH
Oldenburg in Holstein, 23758
Praxis Reinfeld Mitte
Reinfeld
Herz Kreislauf Zentrum - Klinikum Hersfeld Rotenburg GmbH
Rotenburg (Wümme), 36199
Studienzentrum Brinkum
Stuhr
Gemeinschaftspraxis Dr. med. Josef und Dr. med. Wilma Grosskopf
Wallerfing
Forschungszentrum Ruhr
Witten, 58455
INFO-MED Leipzig GmbH
Zwenkau, 4442
United Kingdom27 sites
Ulster Hospital
Belfast
FutureMeds - Soho Road Health Centre
Birmingham, B21 9RY
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Waterloo Medical Centre
Blackpool, FY4 3AD
University Hospital of Wales
Cardiff, CF14 4XW
FutureMeds - Ely Bridge Surgery
Cardiff, CF5 4AD
Darlington Memorial Hospital
Durham, DL3 6HX
Panthera - London North
Enfield, EN3 4GS
Fowey River Practice
Fowey, PL23 1DT
Panthera - Glasgow
Glasgow, G51 4LB
Futuremeds - CPS Research
Glasgow
Hounslow Medical Centre
Hounslow, TW3 3ET
St. Bartholomew's Hospital
London, EC1M 6BQ
The Good Practice
London, SW10 0LR
Chelsea and Westminster Hospital
London, TW7 6AF
Luton and Dunstable University Hospital
Luton, LU4 0DZ
FutureMeds - Bridle Road Clinic
Metropolitan Borough of Wirral, CH62 6EE
Atlantic Medical Group
Penzance, Cornwall, TR18 3DX
Mounts Bay Medical
Penzance, Cornwall, TR19 7HU
Beacon Medical Group
Plymouth, PL7 2QP
Craigavon Area Hospital
Portadown
Panthera - Preston
Preston, PR2 9QB
Panthera - Manchester
Rochdale, OL11 4AU
Queens Hospital
Romford
Panthera - Sheffield
Sheffield, S2 5FX
Sandwell General Hospital
West Bromwich
Worcestershire Royal Hospital
Worcester, WR5 1DD
Hungary25 sites
Lausmed Kft
Baja
Tagore Medical Center
Balatonfüred, 8230
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
Békéscsaba, 5600
Qualiclinic Kft
Budapest, 1036
Semmelweis Egyetem - Szent Rokus Klinikai Tomb
Budapest, 1085
Del-pesti Centrumkorhaz
Budapest, 1097
MED-TIMA Kft
Budapest, 1132
Obudai Egeszsegugyi Centrum - Budapest
Budapest, H-1036
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, H-1122
Clinexpert Kft.
Budapest
High Tech Medical Kft
Budapest
Belinus Bt
Debrecen, 4025
CRU Hungary Kft.
Encs, H-3860
Pharma4 Trial Kft
Gyöngyös
BKS Research Kft.
Hatvan, 3000
Porcika Klinik
Hódmezővásárhely
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár
Pest M. Flór F. Kórház V. Belgy. Oszt
Kistarcsa, H- 2143
Kistarcsai Flor Ferenc Korhaz
Kistarcsa
IPR Hungary Kft
Miskolc
dr Vasas Szilard Haziorvosi Rendelo
Nyíregyháza, 4405
Medifarma-98 Kft
Nyíregyháza, H-4400
dr Nagy Laszlo Kardiologiai Maganrendeles es Klinikai Vizsgalohely
Orosháza, 5900
Coromed SMO Kft
Pécs
Obudai Egeszsegugyi Centrum - Zalaegerszeg
Zalaegerszeg, 8900
Slovakia24 sites
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
Banská Bystrica, 974 01
Alian, s.r.o., Kardiologicka ambulancia
Bardejov, 085 01
DIADA s.r.o.
Bardejov, 085 01
Thyreomedical s.r.o.
Bardejov
Medispektrum s.r.o., Diabetologicka a metabolicka ambulancia
Bratislava
Univerzitna nemocnica Bratislava
Bratislava
Kardiologicka ambulancia NsP, n.o.
Brezno, 977 01
JM-INTERNA, s.r.o., Ambulancia vnutorneho lekarstva
Dolný Kubín
Cardio D&R, S.R.O. Kosice
Košice, 040 22
Human-Care s.r.o
Košice, 4001
Medical group Kosice, s.r.o. - Kardiologicka a Interna ambulancia
Košice, 4001
KardioLEV s. r. o.
Levoča, 054 01
Kardiomed s.r.o.
Lučenec, 984 01
KARDIO 1 s.r.o.
Lučenec, 98401
Interna a diabetologicka ambulancia - IN - DIA s.r.o., MUDr. Livia Tomasova
Lučenec
Univerzitna nemocnica Martin
Martin
Medi M and M sro
Moldava nad Bodvou
Kardiocentrum Nitra s.r.o.
Nitra, 949 01
Medical KG, s.r.o. - Ambulancia vnutorneho lekarstva
Piešťany, 92101
Medispol, s.r.o.
Prešov
Tatratrial s.r.o
Rožňava
Interna SK, s.r.o., Kardiologicka a interna ambulancia
Svidník, 8901
JAL s.r.o.
Trnava, 917 01
Medivasa, s.r.o., Angiologicka a kardiologicka ambulancia
Žilina, 1001
Japan21 sites
Chiba University Hospital
Chiba, 260-8677
New Tokyo Heart Clinic
Chiba, 271-0077
Kokura Memorial Hospital
Fukuoka, 802-8555
Japan Community Health Care Organization Kyushu Hospital
Fukuoka, 806-8501
National Hospital Organization Takasaki General Medical Center
Gunma, 370-0829
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
Hiroshima University Hospital
Hiroshima, 734-8551
Hyogo Prefectural Harima-Himeji General Medical Center
Hyōgo, 670-8560
Ishikawa Prefectural Central Hospital
Ishikawa, 920-8530
Komatsu Municipal Hospital
Ishikawa, 923-8560
Public Central Hospital of Matto lshikawa
Ishikawa, 924-8588
Showa University Northern Yokohama Hospital
Kanagawa, 224-8503
Yokohama Minami Kyousai Hospital
Kanagawa, 236-0037
Niigata University Medical & Dental Hospital
Niigata, 951-8510
The Sakakibara Heart Institute of Okayama
Okayama, 700-0804
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Saiseikai Senri Hospital
Osaka, 565-0862
National Cerebral and Cardiovascular Center Research Institute
Osaka, 565-8565
Osaka Medical and Pharmaceutical University Hospital
Osaka, 569-8686
Tokyo Saiseikai Central Hospital
Tokyo, 108-0073
Nihon University Itabashi Hospital
Tokyo, 173-8610
Netherlands21 sites
Academic Medical Center - Department of Vascular Medicine
Amsterdam, 1105AZ
Ziekenhuis Rijnstate
Arnhem, 6815 AD
Rode Kruis Ziekenhuis
Beverwijk, 1942 LE
Reinier de Graaf Gasthuis
Delft, 2625 AD
Het Van Weel-Bethesda Ziekenhuis
Dirksland, 3247 BW
Albert Schweitzer Ziekenhuis - Location Dordrecht
Dordrecht, 3331 LZ
Ziekenhuis Gelderse Vallei
Ede, 6716 RP
Maxima Medisch Centrum
Eindhoven, 5504 DB
Groene Hart Ziekenhuis
Gouda, 2803 HH
St. Jansdal Ziekenhuis
Harderwijk, 3844 DG
Elkerliek Ziekenhuis - Locatie Helmond
Helmond, 5707 HA
Treant Zorggroep
Hoogeveen, 7827
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Stichting Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, 6532 SZ
Franciscus Gasthuis & Vlietland - Locatie Gasthuis
Rotterdam, PM 3045
HMC Westeinde
The Hague, 2512 VA
Diakonessenhuis - Locatie Utrecht
Utrecht, 3582 KE
VieCuri Medisch Centrum
Venlo, 5912 BL
Zaans Medisch Centrum
Zaandam, 1502 DV
Albert Schweitzer Ziekenhuis - Location Zwijndrecht
Zwijndrecht, 3331 LZ
China20 sites
Peking University First Hospital
Beijing, 100034
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233017
The First People's Hospital of Changde City
Changde, 415003
The Second People's Hospital of Changzhou
Changzhou, 213164
Affiliated Hospital of Chifeng University
Chifeng, 24050
Daqing People's Hospital
Daqing, 163711
Shunde Hospital of Southern Medical University
Foshan, 528308
Guangdong Provincial People's Hospital
Guangzhou, 510080
Heilongjiang Provincial Hospital
Harbin, 150036
The First Affiliated Hospital of Nanyang Medical College - 2nd site
Nanyang, 473024
The First affiliated Hospital of Nanyang Medical College
Nanyang, 473024
Ningbo First Hospital
Ningbo, 315010
Panjin Liaoyou Gem Flower Hospital
Panjin, 124010
Pingxiang People's Hospital
Pingxiang, 337055
People's Hospital of Tianjin
Tianjin, 300121
Tianjin Fourth Central Hospital
Tianjin, 300143
Xi'an Gaoxin Hospital
Xi'an, 710075
Xianyang Hospital of Yan 'an University
Xianyang, 712099
The Third Affiliatied Hospital of Xinxiang Medical University
Xinxiang, 453000
Zibo City Linzi District People's Hospital
Zibo, 255499
Czechia20 sites
Hornicka nemocnice s poliklinikou Bilina s.r.o.
Bílina, 41801
Medicus Services SRO
Brandýs nad Labem, 250 01
Centrum pro zdravi - kardiologie s.r.o.
Brno, 60300
Kardiologicka ambulance Brno s.r.o.
Brno, 612 00
Amkardia sro
Brno
Nemocnice Havlickuv Brod, p.o.
Havlíčkův Brod
Cevni ambulance - MATMED s.r.o.
Hodonín
MUDr. Tomas Edelsberger - diabetologicka ambulance
Krnov
Lunacor s.r.o. - Centrum pro choroby srdce a cev
Kroměříž, 767 01
KARDIOLOGIE - LIBEREC s.r.o.
Liberec, 46014
InterKardio ML s.r.o.
Mariánské Lázně, 353 01
Edumed s.r.o.
Náchod, 551 01
PreventaMed s.r.o.
Olomouc, 779 00
CCR Ostrava s.r.o.
Ostrava, 702 00
Lunacor, s.r.o. - Centrum pro choroby srdce a cev - Otrokovice
Otrokovice, 765 02
Kardiologie COR s.r.o.
Prague, 106 00
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Fakultní nemocnice v Motole
Prague, 15006
Ustredni vojenska nemocnice
Prague, 169 02
Krajska nemocnice T. Bati
Zlín, 762 75
Georgia19 sites
Health Ltd
Batumi
JSC Evex Hospitals - Batumi Referral Hospital
Batumi
Kutaisi Primary Health Care Center #1
Kutaisi
Bokhua Memorial Cardiovascular Center LTD
Tbilisi
Cardioclinic Digomi Medical Center-
Tbilisi
David Metreveli Medical Centre Lt
Tbilisi
Emergency Cardiology Center by Academician G. Chapidze Ltd
Tbilisi
JSC Curatio
Tbilisi
LTD Adapti
Tbilisi
Ltd Georgian-Dutch Hospital
Tbilisi
LTD Israeli -Georgian Medical Research Clinic Healthycore
Tbilisi
Ltd Tbilisi Heart Center
Tbilisi
LTD Vitamed
Tbilisi
Mediclub Georgia
Tbilisi
Multiprofile Clinic Consilium Medulla LTD
Tbilisi
National Center for Diabetes Research
Tbilisi
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi
The First Medical Center LTD
Tbilisi
VivaMedi
Tbilisi
Canada18 sites
Brampton Clinical Trials
Brampton
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
LMC Diabetes & Endocrinology Ltd. - Thornhill
Concord, Ontario, L4K 4M2
Medical Arts Health Research Group - Kamloops
Kamloops, British Columbia, V2C 5T1
Centre de recherche clinique de Laval
Laval
KMH Cardiology & Diagnostic Centres - Mississauga
Mississauga
Medical Arts Health Research Group - North Vancouver
North Vancouver, British Columbia, V7M 2H4
Dr. James Cha
Oshawa, Ontario, L1J2K1
The Medical Arts Health Research Group - Penticton
Penticton, British Columbia, V2A 5L5
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec
CardioVasc HR
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Estrie -Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
KMH Cardiology & Diagnostic Centres - Hamilton
Stoney Creek, Ontario, L8J 3W2
Diex Recherche Trois-Rivieres, Inc
Trois-Rivières, Quebec, G9A 4P3
Discovery Clinical Services, Ltd
Victoria
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 6P6
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Spain16 sites
Hospital Universitario de A Coruna
A Coruña
Hospital General Universitario de Alicante Dr. Balmis
Alicante
Hospital Universitario Torrecardenas
Almería
Hospital del Mar
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario Virgen de las Nieves
Granada
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Clinico Universitario de Santiago
Santiago de Compostela
Hospital Universitario Virgen Macarena
Seville
Hospital Universitario Joan XXIII de Tarragona
Tarragona
Hospital Clinico Universitario de Valencia
Valencia
Hospital Alvaro Cunqueiro
Vigo
Hospital Universitario Miguel Servet
Zaragoza
Australia15 sites
Royal Adelaide Hospital
Adelaide
Flinders Medical Centre
Bedford Park, 5042
Campbelltown Hospital
Campbelltown
The Prince Charles Hospital
Chermside, 4032
Monash Health
Clayton, 3168
Bridge Family Practice
Halls Creek, 6210
Austin Health
Heidelberg, 3084
Baker Heart and Diabetes Institute
Melbourne, VIC 3004
The Alfred Hospital
Melbourne
Redcliffe Hospital
Redcliffe, 4020
Western Health
Saint Albans, VIC 3021
Griffith University
Southport, 4222
Wollongong Hospital (Illawarra Shoalhaven Local Health District)
Wollongong, 2500
The Queen Elizabeth Hospital (TQEH) - SA Health
Woodville South
Dr Heart Pty Ltd at Cholesterol Care Australia
Woolloongabba, 4102
Israel14 sites
Barzilai Medical Center
Ashkelon, 7830604
Bnai Zion Medical Center
Haifa, 3104802
Rambam Health Care Campus
Haifa, 3109601
The Lady Davis Carmel Medical Center
Haifa, 3436212
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Hebrew University Medical Center - Cardiology - The Heart Institute
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 44281
Galilee Medical Cente
Nahariya, 2210001
Rabin Medical Center, Beilinson Hospital - Internal Medicine B
Petah Tikva, 4941492
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492
The BARUCH PADEH Medical Center, Poriya
Poria – Neve Oved, 1520800
Kaplan Medical Center
Rehovot, 7610001
Ziv Medical Center
Safed, 1340305
Shamir Medical Center (Assaf Harofeh)
Tsrifin, 6093000
Italy7 sites
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Ferrara
IRCCS Ospedale San Raffaele
Milan
Azienda Ospedaliera Universitaria Federico II
Naples
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Istituto Clinico Humanitas
Rozzano
Azienda Ospedaliera Santa Maria di Terni
Terni
South Africa7 sites
Iatros International
Bloemfontein
Tiervlei Trial Centre (TTC)
Cape Town
TREAD Research - Department of Cardiology
Cape Town
WCR - Bara Cardiology
Johannesburg, 2013
Dr JM Engelbrecht Trial Site
Somerset West
Helderberg Research Institute
Somerset West
Mediclinic Victoria
Tongaat
Denmark6 sites
Aalborg University Hospital
Aalborg, 9000
Bispebjerg Hospital
Copenhagen, 2000
Amager Hospital
Copenhagen, 2300
Sydvestjysk Hospital
Esbjerg, 6700
Godstrup Regional Hospital (Gødstrup)
Herning, 7400
Viborg Regional Hospital
Viborg, 8800
Croatia5 sites
General Hospital Karlovac
Karlovac, 47000
Special Hospital for Medical Rehabilitation Krapinske Toplice
Krapinske Toplice, 49217
General Hospital Dr Josip Bencevic
Slavonski Brod, 35000
Polyclinic Solmed
Zagreb, 10000
University Hospital Center Zagreb
Zagreb, 10000
Latvia5 sites
Latgales Medical Center
Daugavpils, 5417
SIA ANIO
Daugavpils
D. Saulites-Kandevicas Private Practice
Liepāja
Pauls Stradins Clinical University Hospital Riga
Riga, 1002
Vidzemes Hospital
Valmiera, 4201
Jordan4 sites
Abdali Hospital
Amman
Istishari Hospital
Amman
Irbid Specialty Hospital
Irbid
Pharmaceutical Research Center -Jordan University of Science & Technology/King Abdulla University Hospital - Cardiology
Irbid
Finland3 sites
StudyCor Oy
Jyväskylä, 40620
Satucon Oy Kuopio
Kuopio
Turku University Hospital
Turku, 20521
About this study
Official title: Placebo Controlled, Double Blind, Randomized Cardiovascular Outcome Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With ASCVD Not Adequately Controlled Despite Maximally Tolerated Lipid Modifying Therapies
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.
Read the detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Obicetrapib, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObicetrapibDrug
10mg obicetrapib tablet
PlaceboDrug
Placebo tablet to resemble obicetrapib
| Study group | Role | What they receive |
|---|---|---|
| obicetrapib 10mg | Experimental | one 10mg tablet, once daily. Receives: Drug: Obicetrapib |
| Placebo | Placebo comparator | one placebo tablet, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Effect (MACE)
To evaluate the effect of obicetrapib on the risk of MACE
Measured: 30 months after last participant randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start7 Feb 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-Controlled, Double-Blind, Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Marc Ditmarsch, MD, Study director, NewAmsterdam Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202509
- Sponsor's protocol ID
- TA-8995-304
- Acronym
- PREVAIL
- Status last verified
- Jun 2024
- First submitted
- 22 Nov 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled, Double Blind, Randomized Cardiovascular Outcome Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With ASCVD Not Adequately Controlled Despite Maximally Tolerated Lipid Modifying Therapies
- ClinicalTrials.gov ID
- NCT05202509
- Acronym / sponsor ID
- PREVAIL / TA-8995-304
- Conditions
- Atherosclerotic Cardiovascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,541 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Monash University
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.
Detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-Controlled, Double-Blind, Randomized
| Arm | Type | Receives |
|---|---|---|
| obicetrapib 10mg | Experimental | Drug: Obicetrapibone 10mg tablet, once daily. |
| Placebo | Placebo comparator | Drug: Placeboone placebo tablet, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males \& females ≥ 18 years age.
- Established ASCVD including:
- Coronary artery disease
- Cerebrovascular disease
- Peripheral Artery disease
Key exclusion criteria (15 listed)
- New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%
- Have been hospitalized for Heart Failure within 5 years prior to screening
- Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
- Uncontrolled hypertension
- Diagnosis of homozygous familial hypercholesterolemia (HoFH)
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 |
|---|---|---|
| Obicetrapib10mg obicetrapib tablet | Drug | obicetrapib 10mg |
| PlaceboPlacebo tablet to resemble obicetrapib | Drug | Placebo |
Primary outcome
Major Adverse Cardiovascular Effect (MACE)
Time frame: 30 months after last participant randomized
To evaluate the effect of obicetrapib on the risk of MACE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Marc Ditmarsch, MD study director
NewAmsterdam Pharma
591 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Obicetrapib in people with Atherosclerotic Cardiovascular Disease, run by NewAmsterdam Pharma at 591 sites in 23 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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 591 sites in United States, Poland, Bulgaria, Germany, United Kingdom and 18 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?
This study is still under way. Results are not available in the source record yet.
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?
Major Adverse Cardiovascular Effect (MACE) (time frame: 30 months after last participant randomized). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.