Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
NCT ID: NCT06492291
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
3000 participants
INTERVENTIONAL
2024-08-05
2028-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)
Enlicitide Decanoate
Oral tablet
Interventions
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Enlicitide Decanoate
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had an overall study intervention compliance ≥80% while participating in their parent study
Exclusion Criteria
* Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
* Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
* Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Alliance for Multispecialty Research, LLC ( Site 0027)
Daphne, Alabama, United States
G&L Research ( Site 0035)
Foley, Alabama, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
Phoenix, Arizona, United States
National Heart Institute-Research ( Site 0029)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0054)
Sacramento, California, United States
Velocity Clinical Research, Banning ( Site 0023)
San Bernardino, California, United States
Emerson Clinical Research Institute ( Site 0017)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0010)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0037)
Doral, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0056)
Fort Myers, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 0053)
Hallandale, Florida, United States
Jacksonville Center for Clinical Research ( Site 0025)
Jacksonville, Florida, United States
South Broward Research ( Site 0012)
Miramar, Florida, United States
Progressive Medical Research ( Site 0033)
Port Orange, Florida, United States
Clinical Research Trials of Florida ( Site 0006)
Tampa, Florida, United States
Clinical Site Partners, LLC dba Flourish Research ( Site 0004)
Winter Park, Florida, United States
East Coast Institute for Research, LLC ( Site 0020)
Macon, Georgia, United States
Healthcare Research Network - Chicago ( Site 0051)
Flossmoor, Illinois, United States
Synexus Clinical Research US - Evansville ( Site 0005)
Evansville, Indiana, United States
Midwest Institute For Clinical Research ( Site 0052)
Indianapolis, Indiana, United States
Alliance for Multispecialty Research, LLC ( Site 0001)
Lexington, Kentucky, United States
L-MARC Research Center ( Site 0011)
Louisville, Kentucky, United States
Velocity Clinical Research, Covington ( Site 0026)
Covington, Louisiana, United States
Velocity Clinical Research Rockville ( Site 0022)
Rockville, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
Troy, Michigan, United States
Velocity Clinical Research, Gulfport ( Site 0032)
Gulfport, Mississippi, United States
Healthcare Research Network - St. Louis ( Site 0040)
Hazelwood, Missouri, United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)
Lincoln, Nebraska, United States
Jubilee Clinical Research ( Site 0049)
Las Vegas, Nevada, United States
AB Clinical Trials ( Site 0002)
Las Vegas, Nevada, United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0043)
Albuquerque, New Mexico, United States
Velocity Clinical Research, Syracuse ( Site 0014)
East Syracuse, New York, United States
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)
New York, New York, United States
Lillestol Research ( Site 0030)
Fargo, North Dakota, United States
altoona center for clinical research ( Site 0024)
Duncansville, Pennsylvania, United States
Cardiology Consultants of Philadelphia Yardley ( Site 0021)
Yardley, Pennsylvania, United States
Velocity Clinical Research, Anderson ( Site 0015)
Anderson, South Carolina, United States
Piedmont Research Partners ( Site 0045)
Fort Mill, South Carolina, United States
Coastal Carolina Research Center ( Site 0055)
North Charleston, South Carolina, United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)
Rapid City, South Dakota, United States
Holston Medical Group ( Site 0034)
Kingsport, Tennessee, United States
Alliance for Multispecialty Research, LLC ( Site 0050)
Knoxville, Tennessee, United States
Velocity Clinical Research, Dallas ( Site 0028)
Dallas, Texas, United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)
Houston, Texas, United States
Clinical Trials of Texas, LLC ( Site 0016)
San Antonio, Texas, United States
Synexus Clinical Research US, Inc. ( Site 0003)
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City ( Site 0041)
West Jordan, Utah, United States
Manassas Clinical Research Center ( Site 0007)
Manassas, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0019)
Newport News, Virginia, United States
Alliance for Multispecialty Research, LLC ( Site 0008)
Norfolk, Virginia, United States
National Clinical Research, Inc ( Site 0044)
Richmond, Virginia, United States
Rainier Clinical Research Center ( Site 0013)
Renton, Washington, United States
CEDIC ( Site 0603)
CABA, Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate ( Site 0604)
Zárate, Buenos Aires, Argentina
Fundacion Estudios Clinicos ( Site 0601)
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)
CABA, , Argentina
CIPREC ( Site 0600)
CABA, , Argentina
Fundación Respirar ( Site 0606)
CABA, , Argentina
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
Camperdown, New South Wales, Australia
Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
Clayton, Victoria, Australia
Universidade Federal Do Ceara ( Site 0702)
Fortaleza, Ceará, Brazil
Instituto Dante Pazzanese de Cardiology ( Site 0701)
São Paulo, São Paulo, Brazil
Incor - Instituto do Coracao ( Site 0703)
São Paulo, , Brazil
The Medical Arts Health Research Group ( Site 0506)
North Vancouver, British Columbia, Canada
Cambridge Cardiac Care Centre ( Site 0502)
Cambridge, Ontario, Canada
North York Diagnostic and Cardiac Centre ( Site 0505)
North York, Ontario, Canada
Ecogene-21 ( Site 0500)
Chicoutimi, Quebec, Canada
Institut de Cardiologie de Montreal ( Site 0504)
Montreal, Quebec, Canada
Diex Recherche Trois-Rivieres ( Site 0503)
Trois-Rivières, Quebec, Canada
Clinical Research Chile SpA ( Site 0800)
Valdivia, Los Ríos Region, Chile
CDIEM ( Site 0801)
Providencia, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)
Santiago, Region M. de Santiago, Chile
Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University ( Site 6020)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 6021)
Chongqing, Chongqing Municipality, China
Guangdong Provincial People s Hospital ( Site 6004)
Guangzhou, Guangdong, China
Zhujiang Hospital ( Site 6029)
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital ( Site 6079)
Huizhou, Guangdong, China
The University of Hong Kong-Shenzhen Hospital ( Site 6018)
Shenzhen, Guangdong, China
Jingzhou Central Hospital ( Site 6076)
Jingzhou, Hubei, China
Wuhan Fourth Hospital ( Site 6056)
Wuhan, Hubei, China
Hunan Provincial People's Hospital ( Site 6017)
Changsha, Hunan, China
Changzhou Second People's Hospital ( Site 6073)
Changzhou, Jiangsu, China
Northern Jiangsu People s Hospital ( Site 6008)
Yangzhou, Jiangsu, China
The Third Hospital of Nanchang - Fuhe ( Site 6078)
Nanchang, Jiangxi, China
Siping Central People's Hospital ( Site 6011)
Siping, Jilin, China
Xianyang Hospital of Yan'an University ( Site 6040)
Xianyang, Shaanxi, China
Chengdu Second Municipal People's Hospital ( Site 6032)
Chengdu, Sichuan, China
Lishui City People s Hospital ( Site 6002)
Lishui, Zhejiang, China
Fundación Centro de Investigación Clínica CIC ( Site 0904)
Medellín, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0900)
Barranquilla, Atlántico, Colombia
Clinica de la Costa S.A.S. ( Site 0901)
Barranquilla, Atlántico, Colombia
Salud SURA Calle 100 ( Site 0905)
Bogotá, Cundinamarca, Colombia
Healthy Medical Center S.A.S ( Site 0902)
Zipaquirá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0903)
Cali, Valle del Cauca Department, Colombia
Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
Brno, Brno-mesto, Czechia
Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
Brno, Brno-mesto, Czechia
Institut Klinicke a Experimentalni Mediciny ( Site 3601)
Prague, Praha 4, Czechia
Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
Helsinki, Uusimaa, Finland
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)
Montpellier, Herault, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 5004)
Saint-Herblain, Loire-Atlantique, France
Hospices Civils de Lyon - Hopital Louis Pradel-Service d'endocrinologie, de diabétologie et des mal ( Site 5000)
Bron, Rhone, France
Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1510)
Dresden, Saxony, Germany
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1528)
Hohenmölsen, Saxony-Anhalt, Germany
Zentralklinik Bad Berka ( Site 1531)
Bad Berka, Thuringia, Germany
Velocity Clinical Research GmbH Berlin ( Site 1503)
Berlin, , Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534)
Berlin, , Germany
Queen Mary Hospital-Medical ( Site 3300)
Hksar, , Hong Kong
Prince of Wales Hospital ( Site 3304)
Shatin, , Hong Kong
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
Szeged, Csongrád megye, Hungary
Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
Debrecen, , Hungary
Hillel Yaffe Medical Center ( Site 1731)
Hadera, , Israel
Rambam Health Care Campus ( Site 1739)
Haifa, , Israel
Rambam Health Care Campus ( Site 1742)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 1735)
Jerusalem, , Israel
Hadassah Medical Center ( Site 1732)
Jerusalem, , Israel
Hadassah Medical Center ( Site 1741)
Jerusalem, , Israel
Hadassah Medical Center-Heart Institute ( Site 1734)
Jerusalem, , Israel
Meir Medical Center. ( Site 1737)
Kfar Saba, , Israel
Rabin Medical Center ( Site 1738)
Petah Tikva, , Israel
Rabin Medical Center ( Site 1740)
Petah Tikva, , Israel
Sheba Medical Center ( Site 1733)
Ramat Gan, , Israel
Clalit Health Services - Sakhnin Community Clinic ( Site 1730)
Sakhnin, , Israel
Yitzhak Shamir Medical Center. ( Site 1736)
Ẕerifin, , Israel
Fondazione Policlinico Tor Vergata ( Site 1809)
Rome, Lazio, Italy
Centro Cardiologico Monzino ( Site 1804)
Milan, Milano, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
Turin, Piedmont, Italy
Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
Rome, Roma, Italy
Azienda Ospedaliera Garibaldi ( Site 1810)
Catania, , Italy
Hirohata Naika Clinic ( Site 3513)
Kitakyushu, Fukuoka, Japan
Nakakinen clinic ( Site 3510)
Naka, Ibaraki, Japan
Noritake Clinic ( Site 3512)
Ushiku, Ibaraki, Japan
National Hospital Organization Kanazawa Medical Center ( Site 3508)
Kanazawa, Ishikawa-ken, Japan
Hirano Medical Clinic ( Site 3522)
Morioka, Iwate, Japan
Shirai Healthcare Clinic Izumichuou ( Site 3527)
Sendai, Miyagi, Japan
Rinku General Medical Center ( Site 3503)
Izumisano, Osaka, Japan
Shiraiwa Medical Clinic ( Site 3514)
Kashihara, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
Suita-shi, Osaka, Japan
Saitama Medical University Hospital ( Site 3506)
Iruma, Saitama, Japan
Teramoto Medical and Dental Clinic ( Site 3507)
Bunkyo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic ( Site 3505)
Chuo-ku, Tokyo, Japan
Fukuwa Clinic ( Site 3504)
Chuo-ku, Tokyo, Japan
Teikyo University Hospital ( Site 3500)
Itabashi-ku, Tokyo, Japan
Kato Clinic of Internal Medicine ( Site 3509)
Katsushika-ku, Tokyo, Japan
Kanno Naika ( Site 3511)
Mitaka, Tokyo, Japan
Sugawara Clinic ( Site 3519)
Nerima-ku, Tokyo, Japan
Shin Clinic ( Site 3517)
Ōta-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
Shinjuku-ku, Tokyo, Japan
Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
Hiroshima, , Japan
Mishuku Hospital ( Site 3524)
Tokyo, , Japan
Mitsukoshi Health and Welfare Foundation ( Site 3521)
Tokyo, , Japan
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador -Unidad de Investigación de Enfermedade ( Site 1071)
Mexico City, Mexico City, Mexico
Radboudumc-internal medicine ( Site 1952)
Nijmegen, Gelderland, Netherlands
Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
Amsterdam, North Holland, Netherlands
Dijklander Ziekenhuis ( Site 1953)
Hoorn, North Holland, Netherlands
Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
Utrecht, , Netherlands
Pacific Clinical Research Network - Rotorua ( Site 2902)
Rotorua, Bay of Plenty, New Zealand
New Zealand Clinical Research (Christchurch) ( Site 2901)
Christchurch, Canterbury, New Zealand
Nordlandssykehuset ( Site 2041)
Bodø, Nordland, Norway
Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040)
Oslo, , Norway
Changi General Hospital ( Site 3211)
Singapore, Central Singapore, Singapore
IATROS International ( Site 2204)
Bloemfontein, Free State, South Africa
Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)
Johannesburg, Gauteng, South Africa
Soweto Clinical Trials Centre ( Site 2203)
Soweto, Gauteng, South Africa
TREAD Research ( Site 2201)
Cape Town, Western Cape, South Africa
Tiervlei Trial Centre ( Site 2205)
Cape Town, Western Cape, South Africa
University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2200)
Cape Town, Western Cape, South Africa
Wonju Severance Christian Hospital ( Site 3008)
Wŏnju, Kang-won-do, South Korea
Chonnam National University Hospital ( Site 3014)
Gwangju, Kwangju-Kwangyokshi, South Korea
Seoul National University Bundang Hospital ( Site 3005)
Seongnam, Kyonggi-do, South Korea
Ajou University Hospital ( Site 3006)
Suwon, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 3011)
Cheongju-si, North Chungcheong, South Korea
Dong-A University Hospital-Cardiology ( Site 3013)
Busan, Pusan-Kwangyokshi, South Korea
Pusan National University Hospital-Internal Medicine ( Site 3012)
Busan, Pusan-Kwangyokshi, South Korea
Inje University Haeundae Paik Hospital ( Site 3010)
Haeundae-gu, Pusan-Kwangyokshi, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
Daegu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 3001)
Seoul, , South Korea
Kangbuk Samsung Hospital ( Site 3009)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System ( Site 3002)
Seoul, , South Korea
Asan Medical Center ( Site 3004)
Seoul, , South Korea
Samsung Medical Center-cardiology ( Site 3000)
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
Seoul, , South Korea
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2358)
Málaga, Andalusia, Spain
EBA CENTELLES ( Site 2319)
Centelles, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 2362)
Barcelona, Catalonia, Spain
Hospital de Figueres ( Site 2361)
Figueres, Gerona, Spain
Hospital Abente y Lago ( Site 2356)
A Coruña, La Coruna, Spain
Hospital San Rafael de Coruna ( Site 2363)
A Coruña, La Coruna, Spain
CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
Santiago de Compostela, La Coruna, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 2344)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
Alcorcón, Madrid, Comunidad de, Spain
Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
Castilleja de la Cuesta, Sevilla, Spain
Hospital Universitari Sant Joan de Reus ( Site 2329)
Reus, Tarragona, Spain
HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
Valencia, Valenciana, Comunitat, Spain
EAP Sardenya ( Site 2357)
Barcelona, , Spain
Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2311)
Madrid, , Spain
Hospital Universitario Virgen Macarena-Cardiology ( Site 2352)
Seville, , Spain
Mackay Memorial Hospital -Tamsui Branch ( Site 3109)
New Taipei City, New Taipei, Taiwan
Chi Mei Medical Center ( Site 3104)
Tainan City, Tainan, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital ( Site 3110)
Taipei City, Taipei, Taiwan
Changhua Christian Hospital ( Site 3101)
Changhua, , Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 3100)
Taipei, , Taiwan
Taipei Medical University Hospital ( Site 3108)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 3106)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 3105)
Taoyuan District, , Taiwan
Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
Bornova, İzmir, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 2500)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi University-Cardiology ( Site 2510)
Eskişehir, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522)
Kayseri, , Turkey (Türkiye)
Kocaeli Üniversitesi-Cardiology ( Site 2516)
Kocaeli, , Turkey (Türkiye)
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001)
London, England, United Kingdom
Royal Free Hospital ( Site 4000)
London, England, United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2023-504922-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-3950
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2051240110
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-0616-019
Identifier Type: OTHER
Identifier Source: secondary_id
0616-019
Identifier Type: -
Identifier Source: org_study_id
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