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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05202509
Other study ID # TA-8995-304
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 7, 2022
Est. completion date November 2026

Study information

Verified date June 2024
Source NewAmsterdam Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9541
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males & females = 18 years age. - Established ASCVD including: - Coronary artery disease - Cerebrovascular disease - Peripheral Artery disease - On maximally tolerated lipid-modifying therapy - Fasting LDL-C = 55 mg/dL - Fasting triglycerides < 400 mg/dL - Estimated glomerular filtration rate = 30 mL/min Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Obicetrapib
10mg obicetrapib tablet
Placebo
Placebo tablet to resemble obicetrapib

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide
Australia Flinders Medical Centre Bedford Park
Australia Campbelltown Hospital Campbelltown
Australia The Prince Charles Hospital Chermside
Australia Monash Health Clayton
Australia Bridge Family Practice Halls Creek
Australia Austin Health Heidelberg
Australia Baker Heart and Diabetes Institute Melbourne
Australia The Alfred Hospital Melbourne
Australia Redcliffe Hospital Redcliffe
Australia Western Health Saint Albans
Australia Griffith University Southport
Australia Wollongong Hospital (Illawarra Shoalhaven Local Health District) Wollongong
Australia The Queen Elizabeth Hospital (TQEH) - SA Health Woodville South
Australia Dr Heart Pty Ltd at Cholesterol Care Australia Woolloongabba
Bulgaria MHAT Aytos EOOD Department of Internal Diseases Aytos
Bulgaria Medical Center Doctor Staykov EOOD Burgas
Bulgaria UMHAT Deva Maria Burgas
Bulgaria Medical Center Viva Feniks Dobrich
Bulgaria MHAT Sveti Ivan Rilski Gorna Oryahovitsa
Bulgaria MHAT Haskovo AD Haskovo
Bulgaria MHAT City Clinic - Sveti Georgi EOOD Montana
Bulgaria Medical Center - Cordis OOD Pleven
Bulgaria MHAT Heart and Brain Pleven Pleven
Bulgaria Medical Center for Rehabilitation and Sports Medicine I - Plovdiv EOOD Plovdiv
Bulgaria UMHAT Sveti Georgi EA Plovdiv
Bulgaria Medical Center Rusemed EOOD Ruse
Bulgaria SHATC Medica Cor EAD Ruse
Bulgaria Multiprofile Hospital for Active Treatment (MHAT)- Silistra Silistra
Bulgaria MHAT Dr. Ivan Seliminski AD Sliven
Bulgaria "Medical Center Medic" OOD Sofia
Bulgaria DCC "Ascendent" Sofia
Bulgaria Diagnostic and Consulting Center 22 - Sofia Sofia
Bulgaria Diagnostic consultative center 24 Sofia
Bulgaria Diagnostic Consulting Center Convex EOOD Sofia
Bulgaria MC Doctor Kalchev OOD Sofia
Bulgaria Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD Sofia
Bulgaria Medical Centre Medcross Sofia
Bulgaria MHAT Sveta Sofia EOOD Sofia
Bulgaria Multiprofile Hospital for Active Treatment National Cardiology Hospital Sofia
Bulgaria National Multiprofile Transport Hospital Tsar Boris Treti - Cardiology Clinic Sofia
Bulgaria CardioArt Medical Center Stara Zagora
Bulgaria Medical Center Zara - Med Stara Zagora
Bulgaria UMHAT Prof. Dr. Stoyan Kirkovich Stara Zagora
Bulgaria Diagnostic Consultative Center Chaika Varna
Bulgaria Medical Center Plazmamed Clinic Varna
Bulgaria Specialized Hospital for Active Treatment of Cardiology Varna
Bulgaria Medical Center Medica Plus OOD Veliko Tarnovo
Bulgaria Medical Center Nevromedics Veliko Tarnovo
Bulgaria Medical Center Velingrad 2017 EOOD Velingrad
Canada Brampton Clinical Trials Brampton
Canada Ecogene-21 Chicoutimi Quebec
Canada LMC Diabetes & Endocrinology Ltd. - Thornhill Concord Ontario
Canada Medical Arts Health Research Group - Kamloops Kamloops British Columbia
Canada Centre de recherche clinique de Laval Laval
Canada KMH Cardiology & Diagnostic Centres - Mississauga Mississauga
Canada Medical Arts Health Research Group - North Vancouver North Vancouver British Columbia
Canada Dr. James Cha Oshawa Ontario
Canada The Medical Arts Health Research Group - Penticton Penticton British Columbia
Canada Kawartha Cardiology Clinical Trials Peterborough Ontario
Canada Institut Universitaire de Cardiologie et de Pneumologie De Quebec Quebec
Canada CardioVasc HR Saint-Jean-sur-Richelieu Quebec
Canada Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Estrie -Centre hospitalier universitaire de Sherbrooke (CHUS) Sherbrooke Quebec
Canada KMH Cardiology & Diagnostic Centres - Hamilton Stoney Creek Ontario
Canada Diex Recherche Trois-Rivieres, Inc Trois-Rivières Quebec
Canada Discovery Clinical Services, Ltd Victoria
Canada Diex Recherche Victoriaville Victoriaville Quebec
Canada Winnipeg Clinic Winnipeg Manitoba
China Peking University First Hospital Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu
China The First People's Hospital of Changde City Changde
China The Second People's Hospital of Changzhou Changzhou
China Affiliated Hospital of Chifeng University Chifeng
China Daqing People's Hospital Daqing
China Shunde Hospital of Southern Medical University Foshan
China Guangdong Provincial People's Hospital Guangzhou
China Heilongjiang Provincial Hospital Harbin
China The First affiliated Hospital of Nanyang Medical College Nanyang
China The First Affiliated Hospital of Nanyang Medical College - 2nd site Nanyang
China Ningbo First Hospital Ningbo
China Panjin Liaoyou Gem Flower Hospital Panjin
China Pingxiang People's Hospital Pingxiang
China People's Hospital of Tianjin Tianjin
China Tianjin Fourth Central Hospital Tianjin
China Xi'an Gaoxin Hospital Xi'an
China Xianyang Hospital of Yan 'an University Xianyang
China The Third Affiliatied Hospital of Xinxiang Medical University Xinxiang
China Zibo City Linzi District People's Hospital Zibo
Croatia General Hospital Karlovac Karlovac
Croatia Special Hospital for Medical Rehabilitation Krapinske Toplice Krapinske Toplice
Croatia General Hospital Dr Josip Bencevic Slavonski Brod
Croatia Polyclinic Solmed Zagreb
Croatia University Hospital Center Zagreb Zagreb
Czechia Hornicka nemocnice s poliklinikou Bilina s.r.o. Bílina
Czechia Medicus Services SRO Brandýs Nad Labem
Czechia Amkardia sro Brno
Czechia Centrum pro zdravi - kardiologie s.r.o. Brno
Czechia Kardiologicka ambulance Brno s.r.o. Brno
Czechia Nemocnice Havlickuv Brod, p.o. Havlickuv Brod
Czechia Cevni ambulance - MATMED s.r.o. Hodonin
Czechia MUDr. Tomas Edelsberger - diabetologicka ambulance Krnov
Czechia Lunacor s.r.o. - Centrum pro choroby srdce a cev Kromeríž
Czechia KARDIOLOGIE - LIBEREC s.r.o. Liberec
Czechia InterKardio ML s.r.o. Mariánské Lázne
Czechia Edumed s.r.o. Náchod
Czechia PreventaMed s.r.o. Olomouc
Czechia CCR Ostrava s.r.o. Ostrava
Czechia Lunacor, s.r.o. - Centrum pro choroby srdce a cev - Otrokovice Otrokovice
Czechia Kardiologie COR s.r.o. Prague
Czechia Ustredni vojenska nemocnice Prague
Czechia Fakultní nemocnice v Motole Praha
Czechia Vseobecna fakultni nemocnice v Praze Praha
Czechia Krajska nemocnice T. Bati Zlín
Denmark Aalborg University Hospital Aalborg
Denmark Amager Hospital Copenhagen
Denmark Sydvestjysk Hospital Esbjerg
Denmark Godstrup Regional Hospital (Gødstrup) Herning
Denmark Bispebjerg Hospital Kobenhavn
Denmark Viborg Regional Hospital Viborg
Finland StudyCor Oy Jyväskylä
Finland Satucon Oy Kuopio Kuopio
Finland Turku University Hospital Turku
Georgia Health Ltd Batumi
Georgia JSC Evex Hospitals - Batumi Referral Hospital Batumi
Georgia Kutaisi Primary Health Care Center #1 Kutaisi
Georgia Bokhua Memorial Cardiovascular Center LTD Tbilisi
Georgia Cardioclinic Digomi Medical Center- Tbilisi
Georgia David Metreveli Medical Centre Lt Tbilisi
Georgia Emergency Cardiology Center by Academician G. Chapidze Ltd Tbilisi
Georgia JSC Curatio Tbilisi
Georgia LTD Adapti Tbilisi
Georgia Ltd Georgian-Dutch Hospital Tbilisi
Georgia LTD Israeli -Georgian Medical Research Clinic Healthycore Tbilisi
Georgia Ltd Tbilisi Heart Center Tbilisi
Georgia LTD Vitamed Tbilisi
Georgia Mediclub Georgia Tbilisi
Georgia Multiprofile Clinic Consilium Medulla LTD Tbilisi
Georgia National Center for Diabetes Research Tbilisi
Georgia Tbilisi Heart and Vascular Clinic Ltd Tbilisi
Georgia The First Medical Center LTD Tbilisi
Georgia VivaMedi Tbilisi
Germany Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair Bad Homburg
Germany Diabetespraxis Dr. Braun Berlin
Germany Franziskus Hospital Berlin Berlin
Germany kfgn | Site Operations & Services GmbH - Berlin-Mitte Berlin
Germany Kardiologisch-Angiologische Praxis - Herzzentrum Bremen Bremen
Germany MVZ am Küchwald GmbH Chemnitz
Germany Gemeinschaftspraxis Diabeteszentrum Dortmund Dortmund
Germany St Johannes Hospital Dortmund Dortmund
Germany Kfgn | Site Operations & Services GmbH - Dresden Dresden
Germany Universitaetsklinikum Carl Gustav Carus Dresden Dresden
Germany ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH Elsterwerda
Germany Katholisches Krankenhaus St. Johann Nepomuk Erfurt
Germany Klinisches Forschungszentrum Dr. Hagemann Essen
Germany Studienzentrum Bocholderstrasse Essen
Germany Zentrum für Klinische Studien (diabetes-falkensee.de) Falkensee
Germany ClinPhenomics CVC GmbH Frankfurt
Germany Diabeteszentrum Hamburg West (DZHW) / Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle Hamburg
Germany St. Josefskrankenhaus Heidelberg GmbH Heidelberg
Germany Universitaetsklinikum Schleswig-Holstein Campus Kiel Kiel
Germany Velocity Clinical Research Leipzig GmBH Leipzig
Germany Diabetologikum DDG Ludwigshafe Ludwigshafen
Germany Kliniken Maria Hilf GmbH Krankenhaus St. Franziskus Monchengladbach
Germany CDG Studienambulanz Dr. Hartard München
Germany Klinikum München Klinik Neuperlach München
Germany Praxis Drs. Haggenmiller/Jeserich Nuernberg
Germany RED-Institut GmbH Oldenburg In Holstein
Germany Praxis Reinfeld Mitte Reinfeld
Germany Herz Kreislauf Zentrum - Klinikum Hersfeld Rotenburg GmbH Rotenburg
Germany Studienzentrum Brinkum Stuhr
Germany Gemeinschaftspraxis Dr. med. Josef und Dr. med. Wilma Grosskopf Wallerfing
Germany Forschungszentrum Ruhr Witten
Germany INFO-MED Leipzig GmbH Zwenkau
Hungary Lausmed Kft Baja
Hungary Tagore Medical Center Balatonfüred
Hungary Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo Békéscsaba
Hungary Clinexpert Kft. Budapest
Hungary Del-pesti Centrumkorhaz Budapest
Hungary High Tech Medical Kft Budapest
Hungary MED-TIMA Kft Budapest
Hungary Obudai Egeszsegugyi Centrum - Budapest Budapest
Hungary Qualiclinic Kft Budapest
Hungary Semmelweis Egyetem - Szent Rokus Klinikai Tomb Budapest
Hungary Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika Budapest
Hungary Belinus Bt Debrecen
Hungary CRU Hungary Kft. Encs
Hungary Pharma4 Trial Kft Gyongyos
Hungary BKS Research Kft. Hatvan
Hungary Porcika Klinik Hodmezovasarhely
Hungary Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Kistarcsai Flor Ferenc Korhaz Kistarcsa
Hungary Pest M. Flór F. Kórház V. Belgy. Oszt Kistarcsa
Hungary IPR Hungary Kft Miskolc
Hungary Medifarma-98 Kft Nyiregyhaza
Hungary dr Vasas Szilard Haziorvosi Rendelo Nyíregyháza
Hungary dr Nagy Laszlo Kardiologiai Maganrendeles es Klinikai Vizsgalohely Orosháza
Hungary Coromed SMO Kft Pecs
Hungary Obudai Egeszsegugyi Centrum - Zalaegerszeg Zalaegerszeg
Israel Barzilai Medical Center Ashkelon
Israel Bnai Zion Medical Center Haifa
Israel Rambam Health Care Campus Haifa
Israel The Lady Davis Carmel Medical Center Haifa
Israel Hadassah Hebrew University Medical Center - Cardiology - The Heart Institute Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Galilee Medical Cente Nahariyya
Israel Rabin Medical Center, Beilinson Hospital Petach Tikva
Israel Rabin Medical Center, Beilinson Hospital - Internal Medicine B Petach Tikva
Israel The BARUCH PADEH Medical Center, Poriya Poriyya
Israel Kaplan Medical Center Re?ovot
Israel Ziv Medical Center Safed
Israel Shamir Medical Center (Assaf Harofeh) Zerifin
Italy Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna Ferrara
Italy IRCCS Ospedale San Raffaele Milano
Italy Azienda Ospedaliera Universitaria Federico II Napoli
Italy Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Istituto Clinico Humanitas Rozzano
Italy Azienda Ospedaliera Santa Maria di Terni Terni
Japan Chiba University Hospital Chiba
Japan New Tokyo Heart Clinic Chiba
Japan Japan Community Health Care Organization Kyushu Hospital Fukuoka
Japan Kokura Memorial Hospital Fukuoka
Japan National Hospital Organization Takasaki General Medical Center Gunma
Japan Hiroshima Prefectural Hospital Hiroshima
Japan Hiroshima University Hospital Hiroshima
Japan Hyogo Prefectural Harima-Himeji General Medical Center Hyogo
Japan Ishikawa Prefectural Central Hospital Ishikawa
Japan Komatsu Municipal Hospital Ishikawa
Japan Public Central Hospital of Matto lshikawa Ishikawa
Japan Showa University Northern Yokohama Hospital Kanagawa
Japan Yokohama Minami Kyousai Hospital Kanagawa
Japan Niigata University Medical & Dental Hospital Niigata
Japan The Sakakibara Heart Institute of Okayama Okayama
Japan National Cerebral and Cardiovascular Center Research Institute Osaka
Japan Osaka Medical and Pharmaceutical University Hospital Osaka
Japan Saiseikai Senri Hospital Osaka
Japan Sakurabashi Watanabe Hospital Osaka
Japan Nihon University Itabashi Hospital Tokyo
Japan Tokyo Saiseikai Central Hospital Tokyo
Jordan Abdali Hospital Amman
Jordan Istishari Hospital Amman
Jordan Irbid Specialty Hospital Irbid
Jordan Pharmaceutical Research Center -Jordan University of Science & Technology/King Abdulla University Hospital - Cardiology Irbid
Latvia Latgales Medical Center Daugavpils
Latvia SIA ANIO Daugavpils
Latvia D. Saulites-Kandevicas Private Practice Liepaja
Latvia Pauls Stradins Clinical University Hospital Riga Riga
Latvia Vidzemes Hospital Valmiera
Netherlands Academic Medical Center - Department of Vascular Medicine Amsterdam
Netherlands Ziekenhuis Rijnstate Arnhem
Netherlands Rode Kruis Ziekenhuis Beverwijk
Netherlands Reinier de Graaf Gasthuis Delft
Netherlands HMC Westeinde Den Haag
Netherlands Het Van Weel-Bethesda Ziekenhuis Dirksland
Netherlands Albert Schweitzer Ziekenhuis - Location Dordrecht Dordrecht
Netherlands Ziekenhuis Gelderse Vallei Ede
Netherlands Maxima Medisch Centrum Eindhoven
Netherlands Groene Hart Ziekenhuis Gouda
Netherlands St. Jansdal Ziekenhuis Harderwijk
Netherlands Elkerliek Ziekenhuis - Locatie Helmond Helmond
Netherlands Treant Zorggroep Hoogeveen
Netherlands Leids Universitair Medisch Centrum Leiden
Netherlands Canisius-Wilhelmina Ziekenhuis (CWZ) Nijmegen
Netherlands Stichting Radboud Universitair Medisch Centrum Nijmegen
Netherlands Franciscus Gasthuis & Vlietland - Locatie Gasthuis Rotterdam
Netherlands Diakonessenhuis - Locatie Utrecht Utrecht
Netherlands VieCuri Medisch Centrum Venlo
Netherlands Zaans Medisch Centrum Zaandam
Netherlands Albert Schweitzer Ziekenhuis - Location Zwijndrecht Zwijndrecht
Poland CENTRUM MEDYCZNE INTERCOR Sp. z o.o. Bydgoszcz
Poland Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna Bydgoszcz
Poland Centrum Medyczne Pratia Bydgoszcz Bydgoszcz
Poland DIAB Serwis Popenda Spólka Jawna Chorzów
Poland NZOZ Twoje Zdrowie EL Sp. z o.o. Elblag
Poland Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Adam Grzybowski Gdansk
Poland Uniwersyteckie Centrum Kliniczne, I Klinika Kardiologii Gdansk
Poland Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman Gdynia
Poland Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II Grodzisk Mazowiecki
Poland Centrum Medyczne Pratia Katowice Katowice
Poland SALVIA Lekston i Madej s.j. Katowice
Poland Silmedic Sp. z o.o. Katowice
Poland Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska Krakow
Poland Pratia MCM Krakow Krakow
Poland Centrum Medyczne ZDROWA Kraków
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II - Oddzial Kliniczny Kardiologii Interwencyjnej z Pododdzialem Intenyswengo Nadzoru Kardiologicznego Kraków
Poland Krakowskie Centrum Medyczne Sp. z o.o. Kraków
Poland ETG Lodz - Santa Sp. z. o.o. Lódz
Poland FutureMeds Lodz Lódz
Poland Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus Lódz
Poland INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych Lódz
Poland Clinical Best Solutions - Lublin Lublin
Poland ETG Lublin - Pro Life Medica Sp. z o.o Lublin
Poland KO - MED Centra Kliniczne Lublin II Lublin
Poland Szpital Sw. Anny w Miechowie Miechów
Poland Pomorskie Centra Kardiologiczne Sp. z o.o., SKA - Mragowo Mragowo
Poland ZOZ w Olawie, Oddzial Chorob Wewnetrznych Olawa
Poland Futuremeds Olsztyn Olsztyn
Poland Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik Ostrowiec Swietokrzyski
Poland Centrum Medyczne OMEDICA Jaroslaw Opiela i Beata Opiela s. j. Poznan
Poland NZOZ Neuro-Kard - Ilkowski i Partnerzy Spólka Partnerska Lekarzy Poznan
Poland Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia Ruda Slaska
Poland ETG Siedlce- Lukmed 2 Sp. z o.o. Siedlce
Poland ETG Skierniewice - ClinMedica Research Sp. z o.o. Skierniewice
Poland NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych Sopot
Poland Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna Staszów
Poland Osrodek Badan Klinicznych LabMed Agnieszka Karczmarczyk, Filip Karczmarczyk Spólka Cywilna Szczecin
Poland Prywatny Gabinet Lekarski Jacek Gessek Torun
Poland ETG Warszawa- MCM Polimedica 2 Sp. z o.o. Warsaw
Poland Clinical Best Solutions Sp. z.o.o Spolka Komandytowa Warszawa
Poland FutureMeds Targowek Warszawa
Poland FutureMeds Warszawa Centrum Warszawa
Poland Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Poradnia Prewencji i Leczenia Chorob Metabolicznych, Zaklad Epidemiologii, Prewencji Chorób Ukladu Krazeni Warszawa
Poland 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu Wroclaw
Poland FutureMeds Sp. z o.o Wroclaw
Poland Wroclawska Grupa Medyczna Pankiewicz Spolka Jawna Wroclaw
Poland ETG Zamosc - Pro Life Medica Sp. z o.o Zamosc
Poland KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu Zamosc
Slovakia Medivasa, s.r.o., Angiologicka a kardiologicka ambulancia Žilina
Slovakia Stredoslovensky ustav srdcovych a cievnych chorob, a.s. Banská Bystrica
Slovakia Alian, s.r.o., Kardiologicka ambulancia Bardejov
Slovakia DIADA s.r.o. Bardejov
Slovakia Thyreomedical s.r.o. Bardejov
Slovakia Medispektrum s.r.o., Diabetologicka a metabolicka ambulancia Bratislava
Slovakia Univerzitna nemocnica Bratislava Bratislava
Slovakia Kardiologicka ambulancia NsP, n.o. Brezno
Slovakia JM-INTERNA, s.r.o., Ambulancia vnutorneho lekarstva Dolny Kubin
Slovakia Cardio D&R, S.R.O. Kosice Košice
Slovakia Human-Care s.r.o Kosice
Slovakia Medical group Kosice, s.r.o. - Kardiologicka a Interna ambulancia Kosice
Slovakia KardioLEV s. r. o. Levoca
Slovakia Interna a diabetologicka ambulancia - IN - DIA s.r.o., MUDr. Livia Tomasova Lucenec
Slovakia KARDIO 1 s.r.o. Lucenec
Slovakia Kardiomed s.r.o. Lucenec
Slovakia Univerzitna nemocnica Martin Martin
Slovakia Medi M and M sro Moldava nad Bodvou
Slovakia Kardiocentrum Nitra s.r.o. Nitra
Slovakia Medical KG, s.r.o. - Ambulancia vnutorneho lekarstva Pieštany
Slovakia Medispol, s.r.o. Presov
Slovakia Tatratrial s.r.o Roznava
Slovakia Interna SK, s.r.o., Kardiologicka a interna ambulancia Svidník
Slovakia JAL s.r.o. Trnava
South Africa Iatros International Bloemfontein
South Africa Tiervlei Trial Centre (TTC) Cape Town
South Africa TREAD Research - Department of Cardiology Cape Town
South Africa WCR - Bara Cardiology Johannesburg
South Africa Dr JM Engelbrecht Trial Site Somerset West
South Africa Helderberg Research Institute Somerset West
South Africa Mediclinic Victoria Tongaat
Spain Hospital Universitario de A Coruna A Coruna
Spain Hospital General Universitario de Alicante Dr. Balmis Alicante
Spain Hospital Universitario Torrecardenas Almeria
Spain Hospital del Mar Barcelona
Spain Hospital Universitari de Bellvitge Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital Universitario Reina Sofia Córdoba
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario Virgen de la Victoria Malaga
Spain Hospital Clinico Universitario de Santiago Santiago de Compostela
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitario Joan XXIII de Tarragona Tarragona
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Alvaro Cunqueiro Vigo
Spain Hospital Universitario Miguel Servet Zaragoza
United Kingdom Ulster Hospital Belfast
United Kingdom Birmingham Heartlands Hospital Birmingham
United Kingdom FutureMeds - Soho Road Health Centre Birmingham
United Kingdom Waterloo Medical Centre Blackpool
United Kingdom FutureMeds - Ely Bridge Surgery Cardiff
United Kingdom University Hospital of Wales Cardiff
United Kingdom Darlington Memorial Hospital Durham
United Kingdom Panthera - London North Enfield Town
United Kingdom Fowey River Practice Fowey
United Kingdom Futuremeds - CPS Research Glasgow
United Kingdom Panthera - Glasgow Glasgow
United Kingdom Hounslow Medical Centre Hounslow
United Kingdom Chelsea and Westminster Hospital London
United Kingdom St. Bartholomew's Hospital London
United Kingdom The Good Practice London
United Kingdom Luton and Dunstable University Hospital Luton
United Kingdom Atlantic Medical Group Penzance Cornwall
United Kingdom Mounts Bay Medical Penzance Cornwall
United Kingdom Beacon Medical Group Plymouth
United Kingdom Craigavon Area Hospital Portadown
United Kingdom Panthera - Preston Preston
United Kingdom Panthera - Manchester Rochdale
United Kingdom Queens Hospital Romford
United Kingdom Panthera - Sheffield Sheffield
United Kingdom Sandwell General Hospital West Bromwich
United Kingdom FutureMeds - Bridle Road Clinic Wirral
United Kingdom Worcestershire Royal Hospital Worcester
United States Biofortis, Inc Addison Illinois
United States New Mexico Clinical Research & Osteoporosis Center Inc. Albuquerque New Mexico
United States Advanced Cardiovascular LLC Alexander City Alabama
United States Cambridge Medical Trials Alexandria Louisiana
United States PharmaTex Research, LLC Amarillo Texas
United States Advanced Research Center Anaheim California
United States Community Health Network-Anderson Anderson Indiana
United States Northwest Heart Clinical research Arlington Heights Illinois
United States Javara Inc - Wake Forest Health Network Family Physicians - Sunset Avenue Asheboro North Carolina
United States Atlanta Diabetes Associates Atlanta Georgia
United States Accelemed Research Institute Austin Texas
United States Central Texas Clinical Research Austin Texas
United States Northeast Cardiology Associates Bangor Maine
United States Westside Medical Associates of Los Angeles Beverly Hills California
United States Ascension - Cardiology Specialists of Birmingham Birmingham Alabama
United States Cardiovascular Associates of the Southeast, LLC Birmingham Alabama
United States Central Alabama Research Birmingham Alabama
United States Excel Medical Clinical Trials Boca Raton Florida
United States Advanced Heart Care, LLC Bridgewater New Jersey
United States Chear Center LLC Bronx New York
United States Burke Internal Medicine & Research Burke Virginia
United States Hope Clinical Research LLC Canoga Park California
United States East Coast Institute for Research - Canton Canton Georgia
United States Cary Research Group, LLC Cary North Carolina
United States Javara Inc - Tryon Medical Partners LLC Charlotte North Carolina
United States The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute Charlotte North Carolina
United States Chattanooga Research & Medicine, PLLC Chattanooga Tennessee
United States Javara Inc - Healthy Steps Chevy Chase Maryland
United States IMA Clinical Research, PC Chicago Illinois
United States Meridian Clinical Research - Cincinnati, OH Cincinnati Ohio
United States Meridian Clinical Research - Springfield, OH Cincinnati Ohio
United States Clearwater Cardiovascular and Interventional Consultants Clearwater Florida
United States Innovative Research of West Florida Clearwater Florida
United States Alpine Research Organization, Inc. Clinton Utah
United States Private Practice - O. Alejandro Brusco, MD FACE PA Corpus Christi Texas
United States West Broadway Clinic Council Bluffs Iowa
United States Cardiovascular Associates Research, LLC - Covington, LA Covington Louisiana
United States Clinical Research Collaborative, LLC Cumberland Rhode Island
United States Atlanta Heart Specialists Cumming Georgia
United States Javara Inc - Bridge Creek Family Medicine Cypress Texas
United States Southwest Family Medicine Associates Dallas Texas
United States Texas Health Research & Education Institute Dallas Texas
United States PriMed Clinical Research Dayton Ohio
United States Avail Clinical Research DeLand Florida
United States The Iowa Clinic - Cardiovascular Services Des Moines Iowa
United States Physicians' Research Options (PRO) Draper Utah
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Alta Pharmaceutical Research Center Dunwoody Georgia
United States Cardiology Care Clinic of Lake Oconee Eatonton Georgia
United States South Texas Research Institute Edinburg Texas
United States David Turbay, MD, PLLC El Paso Texas
United States Midwest Cardiovascular Research and Education Foundation Elkhart Indiana
United States Titan Medical Research - Oceanside Encinitas California
United States Eastern Shore Research Institute, LLC Fairhope Alabama
United States Lillestol Research LLC Fargo North Dakota
United States Aa Mrc, Llc Flint Michigan
United States Invesclinic Fort Lauderdale Florida
United States Piedmont Research Partners, LLC Fort Mill South Carolina
United States Javara Inc - Texas Health Care Family Physicians Fort Worth Texas
United States Valley Institute of Research - Fort Worth Fort Worth Texas
United States Mt. Olympus Medical Research Friendswood Texas
United States Stern Cardiovascular Foundation, Inc Germantown Tennessee
United States Healthy Heart Cardiology Grand Rapids Michigan
United States Prevea Health Green Bay Wisconsin
United States Medication Management, LLC Greensboro North Carolina
United States Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health Greensboro North Carolina
United States Clinical Investigation Specialists Gurnee Illinois
United States Mass General Brigham Pentucket Medical Associates - Haverhill Haverhill Massachusetts
United States Apex Medical Research Hazel Crest Illinois
United States New Generation of Medical Research Hialeah Florida
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United States Abington Medical Specialists, P.C. dba AMS Cardiolog Horsham Pennsylvania
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United States BioStar Clinical Research Houston Texas
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United States The Heart Center Research Huntsville Alabama
United States Hutchinson Clinic Hutchinson Kansas
United States Medstar Health Research Institute Hyattsville Maryland
United States Community Health Network Indianapolis Indiana
United States East Coast Institute for Research Jacksonville Florida
United States East Coast Institute for Research - Jacksonville Monroe St Jacksonville Florida
United States East Coast Institute for Research - Jacksonville University Blvd Jacksonville Florida
United States East Coast Institute for Research - Perimeter Park Court Jacksonville Florida
United States NSC Research Johns Creek Georgia
United States NEA Baptist clinic Jonesboro Arkansas
United States West Houston Area Clinical Trial Consultants, LLC Katy Texas
United States Clinical Investigation Specialists Kenosha Wisconsin
United States Holston Medical Group Kingsport Tennessee
United States New Phase Research & Development Knoxville Tennessee
United States East Coast Institute for Research- Lake City Lake City Florida
United States Milton Haber, M.D Laredo Texas
United States AB Clinical Trials Las Vegas Nevada
United States Advanced Biomedical Research of America Las Vegas Nevada
United States Sierra Clinical Research Las Vegas Nevada
United States Clinical Trials of America, LLC - Lenoir, NC Lenoir North Carolina
United States The Research Group of Lexington, LLC Lexington Kentucky
United States Nexgen Research Lima Ohio
United States Clinical Trials Research Lincoln California
United States Meridian Clinical Research- Lincoln, NE Lincoln Nebraska
United States Cardiology and Medicine Clinic Little Rock Arkansas
United States Torrance Clinical Research Institute Inc. Lomita California
United States American Institute of Research Los Angeles California
United States Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Louisville Kentucky
United States Carient Heart & Vascular Manassas Virginia
United States SV Research Marion Ohio
United States Advanced Medical Research (AMR) Maumee Ohio
United States ActivMed Practices and Research - Methuen Methuen Massachusetts
United States A+ Research Inc Miami Florida
United States Columbus Clinical Services Miami Florida
United States Ezy Medical Research Miami Florida
United States Finlay Medical Research Corp Miami Florida
United States Med Research of Florida, LLC Miami Florida
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United States Montana Medical Research, Inc. Missoula Montana
United States Mobile Heart Specialists Mobile Alabama
United States Diabetes and Endocrinology Consultants, P.C Morehead City North Carolina
United States Burke Primary Care Morganton North Carolina
United States McLaren Macomb Regional Medical Center Mount Clemens Michigan
United States Inspira Medical Centers Mullica Hill New Jersey
United States ASHA Clinical Research - Munster, LLC Munster Indiana
United States Cardiovascular Research of Northwest Indiana, LLC Munster Indiana
United States Syed Research Consultants Muscle Shoals Alabama
United States New Generation of Medical Research - Naples Naples Florida
United States BTC of New Bedford New Bedford Massachusetts
United States Advanced Research Institute Inc New Port Richey Florida
United States Mid-Hudson Medical Research, PLLC - New Windsor New Windsor New York
United States IMA Clinical Research PC and Affiliates- New York, NY New York New York
United States York Clinical Research LLC Norfolk Virginia
United States Lynn Institute of Norman Norman Oklahoma
United States DiGiovanna Institute for Medical Education and Research North Massapequa New York
United States North Hills Medical Research, Inc. North Richland Hills Texas
United States Amicis Research Northridge California
United States Amicis Research Center-Northridge Northridge California
United States Valley Clinical Trials, Inc Northridge California
United States Cardiology Associates of Fairfield County Norwalk Connecticut
United States Advocate Health and Hospitals Corporation Oakbrook Terrace Illinois
United States Ocala Research Institute Ocala Florida
United States Lynn Health Science Institute - East Oklahoma City Oklahoma
United States South Carolina Clinical Research LLC Orangeburg South Carolina
United States Ormond Beach Clinical Research LLC Ormond Beach Florida
United States Research Integrity Owensboro Kentucky
United States Tapia Internal Medicine Clinic Paris Texas
United States Linq Research, LLC Pearland Texas
United States Elite Clinical Studies Phoenix Arizona
United States Pinehurst Medical Clinic, Inc. Pinehurst North Carolina
United States Preferred Primary Care Physicians Group - Pleasant Hills Pittsburgh Pennsylvania
United States Styde Research Plano Texas
United States Cardiovascular Research of Knoxville Powell Tennessee
United States Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc Rapid City South Dakota
United States Dominion Medical Associates Richmond Virginia
United States Advanced Cardiology Associates Rochester Hills Michigan
United States Optimal Research, LLC Rockville Maryland
United States Endocrine Research Solutions, Inc Roswell Georgia
United States IMA Clinical Research - St. Louis, MO Saint Louis Missouri
United States St. Louis Heart and Vascular Cardiology Saint Louis Missouri
United States Heart and Vascular Center at Methodist Hospital Saint Louis Park Minnesota
United States Wasatch Clinical Research Salt Lake City Utah
United States Bandera Family HealthCare Research, LLC (BFHC) San Antonio Texas
United States San Antonio Premier Internal Medicine San Antonio Texas
United States Sun Research Institute San Antonio Texas
United States Headlands Research Sarasota Florida
United States Saratoga Clinical Research Saratoga Springs New York
United States Javara Inc - SouthCoast Health Savannah Georgia
United States Syed Research Consultants Sheffield Alabama
United States Sherman Clinical Research Sherman Texas
United States Hillcrest Clinical Research Simpsonville South Carolina
United States Louisiana Heart Center Slidell Louisiana
United States Frontier Clinical Research Smithfield Pennsylvania
United States Cardio Metabolic Institute Somerset New Jersey
United States Revival Research Institute Southgate Michigan
United States Piedmont Healthcare - Statesville Statesville North Carolina
United States Stephenville Medical & Surgical Clinic Stephenville Texas
United States Clinical Research Institute of Arizona, LLC Sun City West Arizona
United States Herman Clinical Research Suwanee Georgia
United States MultiCare Institute for Research and Innovation- Tacoma Tacoma Washington
United States Universal Research Group LLC Tacoma Washington
United States BayCare Health System Tampa Florida
United States JSV Clinical Research Study, Inc Tampa Florida
United States Javara Inc - Highland Woods Health The Woodlands Texas
United States Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center Torrance California
United States Arcturus Healthcare Troy Michigan
United States Oakland Medical Research Center Troy Michigan
United States Eclipse Clinical Research Tucson Arizona
United States Meridian Clinical Research- Endwell, NY Vestal New York
United States Cardiology Partners Clinical Research Institute Wellington Florida
United States Clinical Trials of America West Monroe Louisiana
United States Southgate Medical Group West Seneca New York
United States Great Lakes Medical Research, LLC Westfield New York
United States Kansas Nephrology Research Institute Wichita Kansas
United States West Houston Area Clinical Trial Consultants Wichita Kansas
United States Wilmington Health Associates Wilmington North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Clinical Research of Central Florida Winter Haven Florida
United States Penn State Health Medical Group- Berks Cardiology Wyomissing Pennsylvania
United States Michigan Heart Ypsilanti Michigan
United States Southern Clinical Research, LLC Zachary Louisiana

Sponsors (2)

Lead Sponsor Collaborator
NewAmsterdam Pharma Monash University

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Denmark,  Finland,  Georgia,  Germany,  Hungary,  Israel,  Italy,  Japan,  Jordan,  Latvia,  Netherlands,  Poland,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiovascular Effect (MACE) To evaluate the effect of obicetrapib on the risk of MACE 30 months after last participant randomized
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