Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
NewAmsterdam Pharma
Study ID
NCT05202509
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obicetrapib — DRUG
    10mg obicetrapib tablet
  • Placebo — DRUG
    Placebo tablet to resemble obicetrapib

Study Details

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.

Key Dates

Start date
Feb 7, 2022
Status verified
Jun 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
9,541 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: obicetrapib 10mg
    one 10mg tablet, once daily.
  • Placebo Comparator: Placebo
    one placebo tablet, once daily

Primary Outcome Measure

Major Adverse Cardiovascular Effect (MACE) [ Time Frame: 30 months after last participant randomized ]

Locations (199)

FacilityCityStateZIPSite coordinators
Advanced Cardiovascular LLCAlexander CityAlabama35010-
Ascension - Cardiology Specialists of BirminghamBirminghamAlabama35205-
Cardiovascular Associates of the Southeast, LLCBirminghamAlabama35243-
Central Alabama ResearchBirminghamAlabama35209-
Eastern Shore Research Institute, LLCFairhopeAlabama36532-
The Heart Center ResearchHuntsvilleAlabama35801-
Mobile Heart SpecialistsMobileAlabama36608-
Syed Research ConsultantsMuscle ShoalsAlabama35661-
Syed Research ConsultantsSheffieldAlabama35660-
Elite Clinical StudiesPhoenixArizona85018-
Clinical Research Institute of Arizona, LLCSun City WestArizona85375-
Eclipse Clinical ResearchTucsonArizona85745-
NEA Baptist clinicJonesboroArkansas72405-
Cardiology and Medicine ClinicLittle RockArkansas72204-
Advanced Research CenterAnaheimCalifornia92805-
Westside Medical Associates of Los AngelesBeverly HillsCalifornia90211-
Hope Clinical Research LLCCanoga ParkCalifornia91303-
Titan Medical Research - OceansideEncinitasCalifornia92024-
Clinical Trials ResearchLincolnCalifornia95648-
Torrance Clinical Research Institute Inc.LomitaCalifornia90717-
American Institute of ResearchLos AngelesCalifornia90211-
Amicis ResearchNorthridgeCalifornia91324-
Amicis Research Center-NorthridgeNorthridgeCalifornia91324-
Valley Clinical Trials, IncNorthridgeCalifornia91325-
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorranceCalifornia90502-
Cardiology Associates of Fairfield CountyNorwalkConnecticut06905-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Clearwater Cardiovascular and Interventional ConsultantsClearwaterFlorida33756-
Innovative Research of West FloridaClearwaterFlorida33756-
Avail Clinical ResearchDeLandFlorida32720-
InvesclinicFort LauderdaleFlorida33308-
New Generation of Medical ResearchHialeahFlorida33016-
Qway ResearchHialeahFlorida33010-
East Coast Institute for ResearchJacksonvilleFlorida32086-
East Coast Institute for Research - Jacksonville Monroe StJacksonvilleFlorida32204-
East Coast Institute for Research - Jacksonville University BlvdJacksonvilleFlorida32216-
East Coast Institute for Research - Perimeter Park CourtJacksonvilleFlorida32216-
East Coast Institute for Research- Lake CityLake CityFlorida32055-
A+ Research IncMiamiFlorida33144-
Columbus Clinical ServicesMiamiFlorida33125-
Ezy Medical ResearchMiamiFlorida33175-
Finlay Medical Research CorpMiamiFlorida33126-
Med Research of Florida, LLCMiamiFlorida33186-
ProLive Medical ResearchMiamiFlorida33175-
New Generation of Medical Research - NaplesNaplesFlorida34104-
Advanced Research Institute IncNew Port RicheyFlorida34653-
Ocala Research InstituteOcalaFlorida34471-
Ormond Beach Clinical Research LLCOrmond BeachFlorida32174-
Headlands ResearchSarasotaFlorida34243-
BayCare Health SystemTampaFlorida33614-
JSV Clinical Research Study, IncTampaFlorida33634-
Cardiology Partners Clinical Research InstituteWellingtonFlorida33449-
Clinical Research of Central FloridaWinter HavenFlorida33880-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
East Coast Institute for Research - CantonCantonGeorgia30114-
Atlanta Heart SpecialistsCummingGeorgia30084-
Alta Pharmaceutical Research CenterDunwoodyGeorgia30338-
Cardiology Care Clinic of Lake OconeeEatontonGeorgia31024-
NSC ResearchJohns CreekGeorgia30024-
Endocrine Research Solutions, IncRoswellGeorgia30076-
Javara Inc - SouthCoast HealthSavannahGeorgia31406-
Herman Clinical ResearchSuwaneeGeorgia30024-
Biofortis, IncAddisonIllinois60101-
Northwest Heart Clinical researchArlington HeightsIllinois60005-
IMA Clinical Research, PCChicagoIllinois60602-
Clinical Investigation SpecialistsGurneeIllinois60031-
Apex Medical ResearchHazel CrestIllinois60429-
Advocate Health and Hospitals CorporationOakbrook TerraceIllinois60657-
Community Health Network-AndersonAndersonIndiana46011-
Midwest Cardiovascular Research and Education FoundationElkhartIndiana46514-
Community Health NetworkIndianapolisIndiana46227-
ASHA Clinical Research - Munster, LLCMunsterIndiana46321-
Cardiovascular Research of Northwest Indiana, LLCMunsterIndiana46321-
West Broadway ClinicCouncil BluffsIowa51501-
The Iowa Clinic - Cardiovascular ServicesDes MoinesIowa50266-
Hutchinson ClinicHutchinsonKansas67502-
Kansas Nephrology Research InstituteWichitaKansas67214-
West Houston Area Clinical Trial ConsultantsWichitaKansas67226-
The Research Group of Lexington, LLCLexingtonKentucky40503-
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)LouisvilleKentucky40213-
Research IntegrityOwensboroKentucky42303-
Cambridge Medical TrialsAlexandriaLouisiana71301-
Cardiovascular Associates Research, LLC - Covington, LACovingtonLouisiana70433-
Louisiana Heart CenterSlidellLouisiana70458-
Clinical Trials of AmericaWest MonroeLouisiana71291-
Southern Clinical Research, LLCZacharyLouisiana70791-
Northeast Cardiology AssociatesBangorMaine04401-
Javara Inc - Healthy StepsChevy ChaseMaryland20815-
Medstar Health Research InstituteHyattsvilleMaryland20782-
Optimal Research, LLCRockvilleMaryland32763-
Mass General Brigham Pentucket Medical Associates - HaverhillHaverhillMassachusetts01830-
ActivMed Practices and Research - MethuenMethuenMassachusetts01844-
BTC of New BedfordNew BedfordMassachusetts02740-
Aa Mrc, LlcFlintMichigan48504-
Healthy Heart CardiologyGrand RapidsMichigan49564-
McLaren Macomb Regional Medical CenterMount ClemensMichigan48043-
Advanced Cardiology AssociatesRochester HillsMichigan49546-
Revival Research InstituteSouthgateMichigan48195-
Arcturus HealthcareTroyMichigan48098-
Oakland Medical Research CenterTroyMichigan48085-
Michigan HeartYpsilantiMichigan48197-
Heart and Vascular Center at Methodist HospitalSaint Louis ParkMinnesota55416-
IMA Clinical Research - St. Louis, MOSt LouisMissouri63117-
St. Louis Heart and Vascular CardiologySt LouisMissouri63136-
Montana Medical Research, Inc.MissoulaMontana59808-
Meridian Clinical Research- Lincoln, NELincolnNebraska68510-
AB Clinical TrialsLas VegasNevada89119-
Advanced Biomedical Research of AmericaLas VegasNevada89123-
Sierra Clinical ResearchLas VegasNevada89106-
Advanced Heart Care, LLCBridgewaterNew Jersey08807-
Inspira Medical CentersMullica HillNew Jersey08302-
Cardio Metabolic InstituteSomersetNew Jersey08873-
New Mexico Clinical Research & Osteoporosis Center Inc.AlbuquerqueNew Mexico87106-
Mid-Hudson Medical Research, PLLC - New WindsorNew WindsorNew York12553-
IMA Clinical Research PC and Affiliates- New York, NYNew YorkNew York10036-
DiGiovanna Institute for Medical Education and ResearchNorth MassapequaNew York11758-1802-
Saratoga Clinical ResearchSaratoga SpringsNew York12866-
Chear Center LLCThe BronxNew York10455-
Meridian Clinical Research- Endwell, NYVestalNew York13760-
Southgate Medical GroupWest SenecaNew York14224-
Great Lakes Medical Research, LLCWestfieldNew York14787-
Javara Inc - Wake Forest Health Network Family Physicians - Sunset AvenueAsheboroNorth Carolina27203-
Cary Research Group, LLCCaryNorth Carolina27518-
Javara Inc - Tryon Medical Partners LLCCharlotteNorth Carolina28210-
The Presbyterian Hospital DBA Novant Health Heart and Vascular InstituteCharlotteNorth Carolina28204-
Medication Management, LLCGreensboroNorth Carolina28210-
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone HealthGreensboroNorth Carolina27401-
Clinical Trials of America, LLC - Lenoir, NCLenoirNorth Carolina28645-
Diabetes and Endocrinology Consultants, P.CMorehead CityNorth Carolina28557-
Burke Primary CareMorgantonNorth Carolina28655-
Pinehurst Medical Clinic, Inc.PinehurstNorth Carolina28374-
Piedmont Healthcare - StatesvilleStatesvilleNorth Carolina28625-
Wilmington Health AssociatesWilmingtonNorth Carolina28412-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Lillestol Research LLCFargoNorth Dakota58104-
Meridian Clinical Research - Cincinnati, OHCincinnatiOhio45219-
Meridian Clinical Research - Springfield, OHCincinnatiOhio45246-
PriMed Clinical ResearchDaytonOhio45419-
Nexgen ResearchLimaOhio45805-
SV ResearchMarionOhio43302-
Advanced Medical Research (AMR)MaumeeOhio43537-
Lynn Institute of NormanNormanOklahoma73072-
Lynn Health Science Institute - EastOklahoma CityOklahoma73111-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Abington Medical Specialists, P.C. dba AMS CardiologHorshamPennsylvania19044-
Preferred Primary Care Physicians Group - Pleasant HillsPittsburghPennsylvania15236-
Frontier Clinical ResearchSmithfieldPennsylvania15478-
Penn State Health Medical Group- Berks CardiologyWyomissingPennsylvania19610-
Clinical Research Collaborative, LLCCumberlandRhode Island02864-
Piedmont Research Partners, LLCFort MillSouth Carolina29707-
South Carolina Clinical Research LLCOrangeburgSouth Carolina29118-
Hillcrest Clinical ResearchSimpsonvilleSouth Carolina29681-
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, IncRapid CitySouth Dakota57701-
Chattanooga Research & Medicine, PLLCChattanoogaTennessee37404-
Stern Cardiovascular Foundation, IncGermantownTennessee38138-
Holston Medical GroupKingsportTennessee37660-
New Phase Research & DevelopmentKnoxvilleTennessee37909-
Cardiovascular Research of KnoxvillePowellTennessee37849-
PharmaTex Research, LLCAmarilloTexas79109-
Accelemed Research InstituteAustinTexas78745-
Central Texas Clinical ResearchAustinTexas78705-
Private Practice - O. Alejandro Brusco, MD FACE PACorpus ChristiTexas78414-
Javara Inc - Bridge Creek Family MedicineCypressTexas77433-
Southwest Family Medicine AssociatesDallasTexas75325-
Texas Health Research & Education InstituteDallasTexas76107-
South Texas Research InstituteEdinburgTexas78539-
David Turbay, MD, PLLCEl PasoTexas79905-
Javara Inc - Texas Health Care Family PhysiciansFort WorthTexas76132-
Valley Institute of Research - Fort WorthFort WorthTexas76164-
Mt. Olympus Medical ResearchFriendswoodTexas77546-
Angiocardiac Care of TexasHoustonTexas77025-
BioStar Clinical ResearchHoustonTexas77094-
East Texas Cardiology, PAHoustonTexas77002-
Southwest Clinical TrialsHoustonTexas77074-
Texas Center for Drug DevelopmentHoustonTexas77375-
Texas Heart InstituteHoustonTexas77030-
West Houston Area Clinical Trial Consultants, LLCKatyTexas77493-
Milton Haber, M.DLaredoTexas78041-
North Hills Medical Research, Inc.North Richland HillsTexas76180-
Tapia Internal Medicine ClinicParisTexas75460-
Linq Research, LLCPearlandTexas60602-
Styde ResearchPlanoTexas75093-
Bandera Family HealthCare Research, LLC (BFHC)San AntonioTexas78249-
San Antonio Premier Internal MedicineSan AntonioTexas78220-
Sun Research InstituteSan AntonioTexas78215-
Sherman Clinical ResearchShermanTexas75092-
Stephenville Medical & Surgical ClinicStephenvilleTexas76401-
Javara Inc - Highland Woods HealthThe WoodlandsTexas77382-
Alpine Research Organization, Inc.ClintonUtah84015-
Physicians' Research Options (PRO)DraperUtah84020-
Wasatch Clinical ResearchSalt Lake CityUtah84102-
Burke Internal Medicine & ResearchBurkeVirginia22015-
Carient Heart & VascularManassasVirginia20109-
York Clinical Research LLCNorfolkVirginia23510-
Dominion Medical AssociatesRichmondVirginia23219-
MultiCare Institute for Research and Innovation- TacomaTacomaWashington98405-
Universal Research Group LLCTacomaWashington98405-
Prevea HealthGreen BayWisconsin54303-
Clinical Investigation SpecialistsKenoshaWisconsin53144-

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