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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03071692
Other study ID # K-877-302
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 23, 2017
Est. completion date July 27, 2022

Study information

Verified date July 2023
Source Kowa Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: - nonfatal Myocardial Infarction (MI) - nonfatal ischemic stroke - coronary revascularization; or - Cardio Vascular (CV) death.


Description:

A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements. - Argentina - Brazil - Bulgaria - Canada - Colombia - Czech Republic - Denmark - France - Germany - Hungary - India - Israel - Japan - Mexico - Netherlands - Poland - Romania - Russian Federation - Slovakia - South Africa - Spain - Ukraine - United Kingdom - United States


Recruitment information / eligibility

Status Terminated
Enrollment 10544
Est. completion date July 27, 2022
Est. primary completion date July 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Fasting TG = 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest) 2. HDL-C = 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest) 3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (= 6.5% [48 mmol/mol]), elevated plasma glucose (fasting = 126 mg/dL [7.0 mmol/L], 2-hour = 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value = 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either 1. Age = 50 years if male or = 55 years if female (primary prevention cohort); OR 2. Age = 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following: - i. Prior MI or ischemic (non-hemorrhagic) stroke - ii. Coronary angiographic lesion of = 60% stenosis in a major epicardial vessel or = 50% left main stenosis - iii. Asymptomatic carotid disease with = 70% carotid artery stenosis - iv. Symptomatic carotid disease with = 50% carotid artery stenosis - v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index = 0.9 or other diagnostic testing [eg, toe-brachial index, angiogram, or other imaging study]) - vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy) Exclusion Criteria: 1. Current or planned use of fibrates or agents with PPAR-a agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-? agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed 2. Known sensitivity to PPAR-a agonists or tablet excipients 3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin > 100 mg/day or dietary supplements or prescription omega-3 fatty acids > 1 g/day 4. Type 1 diabetes mellitus

Study Design


Intervention

Drug:
K-877
0.2mg tablet
Placebo
K-877 matching placebo tablet

Locations

Country Name City State
Argentina Hospital Interzonal General de Agudos Dr Jose Penna Bahia Blanca Buenos Aires
Argentina Hospital Italiano Regional del Sur Bahia Blanca Buenos Aires
Argentina Hospital Sirio Libanes Caba Ciudad Autonoma Buenos Aires
Argentina CCBR - Buenos Aires - AR Ciudad Autonoma Buenos Aires
Argentina CEDIC Centro de Investigaciones Clinicas Ciudad Autonoma Buenos Aires
Argentina Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada Ciudad Autonoma Buenos Aires
Argentina CIPREC Ciudad Autonoma Buenos Aires
Argentina Consultorio Dr. Litvak Bruno Ciudad Autonoma Buenos Aires
Argentina Fundacion Favaloro Ciudad Autonoma Buenos Aires
Argentina Hospital Italiano Ciudad Autonoma Buenos Aires Buenos Aires
Argentina Instituto Cardiovascular Buenos Aires Ciudad Autonoma Buenos Aires
Argentina Investigaciones Medicas IMOBA S.R.L Ciudad Autonoma Buenos Aires
Argentina Sanatorio Güemes Ciudad Autonoma de Bs. As. Ciudad Autonoma Buenos Aires
Argentina Centro Medico Viamonte SRL Ciudad Autonoma de Buenos Aires Ciudad Autonoma Buenos Aires
Argentina Clinica del Prado Cordoba
Argentina Hospital Privado Centro Medico de Cordoba S.A Cordoba
Argentina Inst. Privado de Inv. Clinicas de Cordoba Cordoba
Argentina Instituto Medico DAMIC Cordoba
Argentina Instituto de Cardiologia de Corrientes Corrientes
Argentina CICLO La Plata Buenos Aires
Argentina Centro de Investigaciones Medicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto de Investigaciones Clinicas Mar del Plata Buenos Aires
Argentina Prevencion Cardiovascular Salta Salta
Argentina Axismed S.R.L.- Clínica Mayo San Miguel de Tucuman Tucuman
Argentina Instituto Clinico Metabolico San Nicolas Buenos Aires
Argentina Instituto de Investigaciones Clinicas San Nicolas San Nicolas Buenos Aires
Argentina Centro Medico Luquez San Vicente Cordoba
Argentina Clinica Olivos Vicente Lopez Buenos Aires
Argentina CEMEDIC - Centro de Especialidades Medicas Villa Luro Ciudad Autonoma Buenos Aires
Brazil HUJBB-UFPA - Hospital Universitário João de Barros Barreto - Universidade Federal do Pará Belém Pará
Brazil CARDRESEARCH - Cardiologia Assistencial Belo Horizonte Minas Gerais
Brazil Hospital Felício Rocho Belo Horizonte Minas Gerais
Brazil Maestri e Kormann Consultoria Medico Científica LTDA Blumenau Santa Catarina
Brazil CECAP - Centro de Cardiologia Clínica Brasília Distrito Federal
Brazil Clínica de Endocrinologia e Metabologia Ltda. Brasília Distrito Federal
Brazil Hospital do Coração do Brasil Brasília Distrito Federal
Brazil Hospital Universitário de Brasília Brasília Distrito Federal
Brazil L2IP - Instituto de Pesquisas Clínicas Ltda. Brasília Distrito Federal
Brazil Sociedade Hospitalar Angelina Caron Campina Grande do Sul Paraná
Brazil IPCC - Instituto de Pesquisa Clínica de Campinas Campinas Sao Paulo
Brazil Loema - Instituto de Pesquisa Clínica Campinas Sao Paulo
Brazil Hospital Universitário Canoas Rio Grande Do Sul
Brazil Cline Research Center (Leite PS Consultoria Medica LTDA) Curitiba Paraná
Brazil Núcleo de Pesquisa Clínica S/S Curitiba Paraná
Brazil CARDIOINTERV Centro de Pesquisa S/S Goiânia Goiás
Brazil HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia Goiás
Brazil Via Médica Goiânia Goiás
Brazil Paraná Medical Research Center Maringá Paraná
Brazil Eurolatino Natal Pesquisas Médicas Ltda. Natal Rio Grande Do Norte
Brazil Hospital São Vicente de Paulo Passo Fundo Rio Grande Do Sul
Brazil Santa Casa de Misericórdia de Pelotas Pelotas Rio Grande Do Sul
Brazil Centro de Pesquisa Clínica Maimônides - Maimônides Day Hospital Porto Alegre Rio Grande Do Sul
Brazil Centro de Pesquisas em Diabetes Ltda. Porto Alegre Rio Grande Do Sul
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda. Rio de Janeiro Rio Do Janeiro
Brazil Centro de Pesquisa Médica Santa Maria Ltda. Santa Maria Rio Grande Do Sul
Brazil CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo Sao Paulo
Brazil Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto Sao Paulo
Brazil ISPEM - Instituto São José dos Campos em Pesquisas Médicas São José dos Campos Sao Paulo
Brazil CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos São Paulo Sao Paulo
Brazil Clínica Paulista de Doenças Cardiovasculares Ltda. São Paulo Sao Paulo
Brazil CPCLIN - Centro de Pesquisas Clínicas Ltda. São Paulo Sao Paulo
Brazil CPQuali Pesquisa Clínica Ltda. São Paulo Sao Paulo
Brazil Dr. Consulta São Paulo Sao Paulo
Brazil Hospital das Clínicas da Faculdade de Medicina da USP São Paulo Sao Paulo
Brazil Incor - Instituto do Coração - HCFMUSP São Paulo Sao Paulo
Brazil IMC - Instituto de Moléstias Cardiovasculares Tatuí Tatuí Sao Paulo
Brazil Santa Casa de Votuporanga Votuporanga Sao Paulo
Bulgaria MHAT 'Puls' AD Blagoevgrad
Bulgaria MHAT - Blagoevgrad, EOOD Blagoevgrad
Bulgaria MHAT "Yuliya Vrevska - Byala", EOOD Byala
Bulgaria MHAT-Haskovo, AD Haskovo
Bulgaria MHAT "Higia", AD - Pazardzhik Pazardzhik
Bulgaria MHAT - Pazardzhik AD Pazardzhik
Bulgaria MHAT "Sv. Pantaleymon - Pleven", OOD Pleven
Bulgaria SHATC Pleven EAD Pleven
Bulgaria UMHAT 'Dr. Georgi Stranski', EAD Pleven
Bulgaria UMHAT "Kaspela", EOOD Plovdiv
Bulgaria UMHAT "Sv. Georgi", EAD Plovdiv
Bulgaria MC Rusemed ltd. Ruse
Bulgaria Acibadem City Clinic Tokuda Hospital Ead Sofia
Bulgaria DCC "Alexandrovska", EOOD Sofia
Bulgaria Diagnostic Consultation Center CONVEX EOOD Sofia
Bulgaria Diagnostic Consultative Center II - Sofia OOD Sofia
Bulgaria Fifth MHAT - Sofia EAD Sofia
Bulgaria Fourth MHAT - Sofia EAD Sofia
Bulgaria MC "Synexus - Sofia", EOOD Sofia
Bulgaria MC Start - d-r Todor Dimitrov EOOD Sofia
Bulgaria Medical Center Kalimat Sofia
Bulgaria MHAT "Lyulin", EAD Sofia
Bulgaria MHAT - "National Heart Hospital" EAD Sofia
Bulgaria NMTH "Tsar Boris III" Sofia
Bulgaria UMHAT "Alexandrovska" EAD Sofia
Bulgaria UMHAT "SofiaMed", OOD Sofia
Bulgaria UMHAT 'Sveta Anna' AD Sofia
Bulgaria UMHAT 'Tsaritsa Yoanna - ISUL', EAD Sofia
Bulgaria MC "Orfey", EOOD Stara Zagora
Bulgaria SHATC "Cardiolife", OOD Varna
Bulgaria SHATC - Varna, EOOD Varna
Bulgaria MHAT "Sv. Panteleymon", AD Yambol
Canada LMC Clinical Research Inc. (Barrie) Barrie Ontario
Canada Aggarwal and Associates Ltd Brampton Ontario
Canada LMC Clinical Research Inc. (Brampton) Brampton Ontario
Canada JBN Medical Diagnostic Services Inc. Burlington Ontario
Canada LMC Clinical Research dba Manna Research Inc. Burlington North Burlington Ontario
Canada LMC Clinical Research Inc. (Calgary) Calgary Alberta
Canada Cambridge Cardiac Care Centre Cambridge Ontario
Canada Joanne F. Liutkus Medicine Professional Corporation Cambridge Ontario
Canada Saul Vizel Professional Medicine Corporation Cambridge Ontario
Canada Ecogene-21 Chicoutimi Quebec
Canada LMC Clinical Research Inc. (Thornhill) Concord Ontario
Canada ALTA Clinical Research Inc. Edmonton Alberta
Canada Royal Alexandra Hospital, CK Hui Heart Centre Edmonton Alberta
Canada LMC Clinical Research Inc. (Etobicoke) Etobicoke Ontario
Canada ViaCar Recherche Clinique Inc Greenfield Park Quebec
Canada Dawson Road Family Medical Clinic Guelph Ontario
Canada Clinique de Cardiologie de Levis Lévis Quebec
Canada Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud Longueuil Quebec
Canada LMC Clinical Research dba Manna Research Inc. Mirabel Mirabel Quebec
Canada Applied Medical Informatics Research Inc. Montreal Quebec
Canada CHUM Hôtel-Dieu Montreal Quebec
Canada Clinique Santé Cardio MC Montréal Quebec
Canada LMC Clinical Research Inc. (Ottawa) Nepean Ontario
Canada Fraser Clinical Trials Inc. New Westminster British Columbia
Canada LMC Clinical Research Inc. (Oakville) Oakville Ontario
Canada James Cha, MD Oshawa Ontario
Canada The Ottawa Hospital - Riverside Campus Ottawa Ontario
Canada Kawartha Cardiology Clinical Trials Peterborough Ontario
Canada Clinique des maladies Lipidiques de Quebec Quebec
Canada DIEX Recherche Quebec Inc. Quebec
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec Quebec
Canada ALPHA Recherche Clinique Québec Quebec
Canada Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis Québec Quebec
Canada Recherche Clinique Sigma Inc. Québec Quebec
Canada The Bailey Clinic Red Deer Alberta
Canada LMC Clinical Research Inc. (Montreal) Saint-Laurent Quebec
Canada Scarborough Cardiology Research Scarborough Ontario
Canada Recherche Médicale St-Jérôme Inc. St-Jérôme Quebec
Canada Centre Medical des Carrieres St-Marc-des-Carrieres Quebec
Canada Health Sciences Centre St. John's Newfoundland and Labrador
Canada Janik Research Sudbury Ontario
Canada Surrey Memorial Hospital Surrey British Columbia
Canada Humber River Hospital Toronto Ontario
Canada LMC Clinical Research dba Manna Research Inc. Toronto Toronto Ontario
Canada LMC Clinical Research Inc. (Bayview) Toronto Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada BC Diabetes As Operated by Dr. TG Elliott, Inc. Vancouver British Columbia
Canada Discovery Clinical Services Ltd. Victoria British Columbia
Canada Rivergrove Medical Clinic Winnipeg Manitoba
Canada Saint Boniface General Hospital Winnipeg Manitoba
Canada Winnipeg Clinic Winnipeg Manitoba
Colombia Centro de Investigacion Medico Asistencial S.A.S Barranquilla
Colombia IPS Centro Cientifico Asistencial S.A.S Barranquilla
Colombia Dexa Diab Servicios Médicos Limitada. Bogota
Colombia Solano y Terront Servicios Médicos Ltda. Bogota
Colombia Centro Cardiovascular Aristides Sotomayor Santa Lucia S.A.S. - IPS ASTALUC S.A.S. IPS Cartagena
Colombia Fundación Centro de Investigaciones Biomédicas Riescard Espinal
Colombia Fundación Oftalmológica de Santander - FOSCAL Floridablanca
Colombia Centro de Investigación Clínica CIC Medellin
Czechia Medicentrum Beroun spol. s.r.o. Beroun
Czechia Fakultni nemocnice u sv. Anny v Brne Brno
Czechia Nemocnice Milosrdnych bratri Brno
Czechia EDUMED s.r.o Broumov
Czechia Poliklinika Chocen a.s. Chocen
Czechia Ordinace pro choroby srdce s.r.o. Chomutov
Czechia MUDr. Jan Hubac s.r.o. Chrudim
Czechia Nemocnice Havlickuv Brod p.o. Havlickuv Brod
Czechia Kardio-Pisova s.r.o. Hradec Kralove
Czechia MUDr. Tomas Edelsberger Krnov
Czechia EDUMED s.r.o Nachod
Czechia Agentura Science Pro Spol. s.r.o. Olomouc
Czechia PreventaMed s.r.o. Olomouc
Czechia CCR Ostrava s.r.o. Ostrava
Czechia Corintez s.r.o. Prague
Czechia Synexus Czech s.r.o. Praha
Czechia Nemocnice na Frantisku Praha 1
Czechia MUDr. Jan KVASNICKA CSc. Angiologie kardiologie a interna Praha 10
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia ResTrial s.r.o. Praha 8
Czechia MUDr.Eva Mandakova MBA Rakovnik
Czechia Nemocnice Slany Slany
Czechia AeskuLab k.s. Teplice
Czechia Kardiologicka ambulance MUDr. Ferkl s.r.o. Trutnov
Czechia Clinical Trials Services s.r.o Uherske Hradiste
Czechia MUDr. Nina Zemkova s.r.o. Uherske Hradiste
Denmark Ålborg Universitets Hospital Aalborg
Denmark Bioclinica Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Bioclinica Ballerup
Denmark Amager-Hvidovre Hospital Copenhagen S
Denmark Sydvestjyds Sygehus Esbjerg Esbjerg
Denmark Amager-Hvidovre Hospital Glostrup
Denmark Herlev og Gentofte Hospital Hellerup
Denmark Herlev og Gentofte Hospital Herlev
Denmark Regionshospitalet Herning-Hospitalsenheden Vest Herning
Denmark Holbæk Sygehus Holbæk
Denmark Sjællands Universitetshospital Roskilde
Denmark OUH Svendborg
Denmark Bioclinica Vejle
France CHU Tours - Hôpital Trousseau Chambray Les Tours Indre Et Loire
France CHU Nantes - Hopital Nord Laënnec Nantes cedex 01 Loire Atlantique
France Hôpital Bichat - Claude Bernard Paris cedex 18 Paris
Germany Neurologische Praxis Dr. Schoell & Kollegen Bad Homburg Hessen
Germany Diabetespraxis Prenzlauer Allee Berlin
Germany Institut fuer klinische Forschung und Entwicklung Berlin GmbH Berlin
Germany Studienzentrum Rankestrasse Berlin
Germany Synexus Clinical Research GmbH Berlin
Germany Synexus Clinical Research GmbH Bochum Nordrhein Westfalen
Germany Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch Dortmund Nordrhein Westfalen
Germany Kardiologische Praxis Gemeinschaftspraxis Dortmund Nordrhein Westfalen
Germany Klinikum Bielefeld gem. GmbH Dortmund Nordrhein Westfalen
Germany St. Johannes Hospital Dortmund Nordrhein Westfalen
Germany ZKS-Südbrandenburg -center for clinical studies Südbrandenburg GmbH Elsterwerda Brandenburg
Germany Katholisches Krankenhaus "St. Johann Nepomuk" Erfurt Thueringen
Germany ClinPhenomics GmbH & Co KG Frankfurt Hessen
Germany Synexus Clinical Research GmbH Frankfurt Hessen
Germany Universitaetsklinikum Freiburg Freiburg Baden Wuerttemberg
Germany Gemeinschaftspraxis fuer innere Medizin und Diabetologie Hamburg
Germany Gemeinschaftspraxis Dr. Klein/ Minnich Kuenzing Bayern
Germany Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut Leipzig Sachsen
Germany Synexus Clinical Research GmbH Leipzig Sachsen
Germany Deutsches Herzzentrum Muenchen Muenchen Bayern
Germany Klinikum der Universitaet Muenchen Muenchen Bayern
Germany GP Dr. Haggenmiller, PD Dr. Michael Jeserich Naumburg Bayern
Germany Dr. Uwe Böckmann / Birgit Jacobs - Diabeteszentrum Neumünster Neumünster Schleswig Holstein
Germany RED - Institut GmbH Oldenburg Schleswig Holstein
Germany Klinische Forschung Schwerin GmbH Schwerin Mecklenburg Vorpommern
Germany Zentrum fuer Praevention und Rehabilitation Siegen Nordrhein Westfalen
Germany Praxis fuer Praevention und Therapie Villingen-Schwenningen Baden Wuerttemberg
Hungary Lausmed Kft. Baja
Hungary Principal SMO Kft. Baja
Hungary DRC Gyogyszervizsgalo Kozpont Kft. Balatonfured
Hungary Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Bekescsaba
Hungary Belgyogyaszati es Kardiologiai Maganrendelo Bekescsaba
Hungary Clinexpert Kft. Budapest
Hungary CSALADGYOGYASZ Kft. Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Synexus Magyarorszag Kft. Budapest
Hungary Borvo Clinic Kft. Debrecen
Hungary Debreceni Egyetem Debrecen
Hungary Meditoll Kft. Godollo
Hungary Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza Gyula
Hungary Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Gyula DRS Gyula
Hungary BKS Research Kft. Hatvan
Hungary Z+P MED Egeszsegugyi, Kereskedelmi es Szolgaltato Bt. Kalocsa
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Selye Janos Korhaz Komarom
Hungary IPR Hungary Kft. Miskolc
Hungary Kanizsai Dorottya Korhaz Nagykanizsa
Hungary BORBANYA PRAXIS Kft. Nyiregyhaza
Hungary Medifarma-98 Kft. Nyiregyhaza
Hungary Dr. Nagy Laszlo Kardiologiai Maganrendeles Oroshaza
Hungary Da Vinci Maganklinika Pecs
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar
Hungary Tolna Megyei Balassa Janos Korhaz Szekszard
Hungary Csolnoky Ferenc Korhaz Veszprem
Hungary Zala Megyei Szent Rafael Korhaz Zalaegerszeg
India Ahmedabad Bariatrics and Cosmetics Pvt Ltd. Ahmedabad Gujarat
India S. A. L. Hospital & Medical Institute Ahmedabad Gujarat
India Fortis Hospitals Ltd. Bangalore Karnataka
India K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka
India Institute of Medical Sciences and SUM Hospital Bhubaneshwar Orissa
India Institute of Cardiovascular Diseases Madras Medical Mission Chennai Tamilnadu
India SRM Institutes for Medical Sciences Chennai Tamilnadu
India Maharaja Agrasen Hospital Delhi
India Medanta The Medicity Gurgaon Haryana
India GNRC Hospital Guwahati Assam
India Eternal Heart Care Centre Jaipur Rajasthan
India IPGMER and SSKM Hospital Kolkata West Bengal
India KRM Hospital & Research Centre Lucknow Uttar Pradesh
India JSS Hospital Mysuru Karnataka
India DDMM Heart Institute Nadiad Gujarat
India Meditrina Institute Of Medical Sciences Nagpur Maharashtra
India Supe Heart & Diabetes Hospital & Research Centre Nashik Maharashtra
India Vijaya Super Speciality Hospital Nellore Andhra Pradesh
India Fortis Flight Lieutenant Rajan Dhall Hospital New Delhi Delhi
India Loknayak Hospital New Delhi Delhi
India Sir Gangaram Hospital New Delhi Delhi
India 7-Orange Hospital Pimpri-Chinchwad Maharashtra
India King Edward Memorial Hospital Research Centre Pune Maharashtra
India Shree Multispecialty Hospital Pune Maharashtra
India BAPS Pramukhswami Hospital Surat Gujarat
India Shri B. D. Mehta Mahavir Heart Institute Surat Gujarat
India Medical College Thiruvananthapuram Kerala
India Aashirwad Hospital Ulhasnagar Maharashtra
India Rhythm Heart Institute Vadodara Gujarat
India Sterling Hospital Vadodara Gujarat
India Galaxy Hospital Varanasi Uttar Pradesh
Israel HaEmek Medical Center Afula
Israel Bnai Zion Medical Center Haifa
Israel Rambam Health Care Center Haifa
Israel The Lady Davis Carmel Medical Center Haifa
Israel Wolfson Medical Center Holon
Israel Hadassah University Hospital - Ein Kerem Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Rabin Medical Center-Beilinson Campus Petach Tikva
Israel Chaim Sheba Medical Center Ramat-Gan
Israel Kaplan Medical Center Rechovot
Israel Ziv Medical Center Safed
Israel Diabetes Medical Center Tel Aviv
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Japan Juntendo University Hospital Bunkyo-ku Tokyo-To
Japan Chiba University Hospital Chiba-shi Chiba-Ken
Japan Fukuwa Clinic Chuo-ku Tokyo-To
Japan Tokyo-Eki Center-Building Clinic Chuo-Ku Tokyo-To
Japan Nakahama Heart Clinic Fuchu-shi Hiroshima-Ken
Japan Fukuoka University Hospital Fukuoka-shi Fukuoka-Ken
Japan Nippon Kokan Fukuyama Hospital Fukuyama-shi Hiroshima-Ken
Japan Public Central Hospital of Matto Ishikawa Hakusan-shi Ishikawa-Ken
Japan NHO Hamada Medical Center Hamada-shi Shimane-Ken
Japan NHO Higashihiroshima Medical Center Higashihiroshima-shi Hiroshima-Ken
Japan Iwasaki Naika Clinic Higashiosaka-shi Osaka-Fu
Japan Takekawa Naika Clinic Higashiosaka-shi Osaka-Fu
Japan Tanaka Cardiology Clinic Hitachinaka-shi Ibaraki-Ken
Japan IMS Miyoshi General Hospital Iruma-gun Saitama-Ken
Japan Nomura Clinic Itabashi-ku Tokyo-To
Japan Rinku General Medical Center Izumisano-shi Osaka-Fu
Japan Shiraiwa Medical Clinic Kashiwara-shi Osaka-Fu
Japan Fukuoka Tokushukai Hospital Kasuga-shi Fukuoka-Ken
Japan Hosoda Clinic Katsushika-ku Tokyo-To
Japan Sugiura Clinic Kawaguchi-shi Saitama-Ken
Japan Tokushukai Kishiwada Tokushukai Hospital Kishiwada-shi Osaka-Fu
Japan Steel Memorial Yawata Hospital Kitakyushu-shi Fukuoka-Ken
Japan NHO Fukuoka Higashi Medical Center Koga-shi Fukuoka-Ken
Japan NHI Komatsu Municipal Hospital Komatsu-shi Ishikawa-Ken
Japan Hoshi General Hospital Koriyama-shi Fukushima-Ken
Japan Southern Tohoku Medical Clinic Koriyama-shi Fukushima-Ken
Japan Kumamoto University Hospital Kumamoto-shi Kumamoto-Ken
Japan Ijinkai Takeda General Hospital Kyoto-shi Kyoto-Fu
Japan Kyoto University Hospital Kyoto-shi Kyoto-Fu
Japan Rakuwakai Otowa Hospital Kyoto-shi Kyoto-Fu
Japan Kioroshikai Chibanishi General Hospital Matsudo-shi Chiba-Ken
Japan Seikeikai New Tokyo Heart Clinic Matsudo-shi Chiba-Ken
Japan Ehime Prefectural Central Hospital Matsuyama-shi Ehime-Ken
Japan Toyukai Yutenji Medical Clinic (Yutenji Naika) Meguro-ku Tokyo-To
Japan Iwate Medical University Uchimaru Medical Center Hospital Morioka-shi Iwate-Ken
Japan Kuonkai Kamata Medical Clinic Morioka-shi Iwate-Ken
Japan Aichi Medical University Hospital Nagakute-shi Aichi-Ken
Japan JOHAS Chubu Rosai Hospital Nagoya-shi Aichi-Ken
Japan Kojunkai Daido Clinic Nagoya-shi Aichi-Ken
Japan NHO Nagoya Medical Center Nagoya-shi Aichi-Ken
Japan Nakakinen Clinic Medical Corporation Kensei-kai Naka-shi Ibaraki-Ken
Japan Okinawa Tokushukai Chubu Tokushukai Hospital Nakagami-gun Okinawa-Ken
Japan National Center For Geriatrics And Gerontology Obu-shi Aichi-Ken
Japan Keiwakai Oita Oka Hospital Oita-shi Oita-Ken
Japan Okayama University Hospital Okayama-shi Okayama-Ken
Japan Chiyukai Fukuoka Shinmizumaki Hospital Onga-gun Fukuoka
Japan Kansai Electric Power Hospital Osaka-shi Osaka-Fu
Japan Sato Hospital Osaki-shi Miyagi-Ken
Japan Shiga University of Medical Science Hospital Otsu-shi Shiga-Ken
Japan Sohken Yamamoto Clinic Sagamihara-shi Kanagawa-Ken
Japan Miyanosawa Clinic of Internal Medicine and Cardiology Sapporo-shi Hokkaido
Japan Sendai Kousei Hospital Sendai-shi Miyagi-Ken
Japan Tohoku Kosai Hospital Sendai-shi Miyagi-Ken
Japan Jichi Medical University Hospital Shimotsuke-shi Tochigi-Ken
Japan Shinjuku Research Park Clinic Shinjuku-ku Tokyo-To
Japan National Cerebral and Cardiovascular Center Suita-shi Osaka-Fu
Japan Josuikai Olive Takamatsu Medical Clinic Takamatsu-shi Kagawa-Ken
Japan Ryubokai Higashi Diabetes and Cardiovascular Clinic Tamana-shi Kumamoto-Ken
Japan Sanyukai Saino Clinic Tokorozawa-shi Saitama-Ken
Japan Fujita Health University Hospital Toyoake-shi Aichi-Ken
Japan Senrichuo Ekimae Clinic Toyonaka-shi Osaka-Fu
Japan Yamaguchi University Hospital Ube-shi Yamaguchi-Ken
Japan NHO Saitama National Hospital Wako-shi Saitama-Ken
Japan NHO Yokohama Medical Center Yokohama-shi Kanagawa-Ken
Mexico Centro de Investigacion Clinica del Pacifico, S.A. de C.V. Acapulco de Juárez Guerrero
Mexico Centro de Investigacion Cardiometabolica de Aguascalientes S.A de C.V Aguascalientes
Mexico Investigacion En Salud Y Metabolismo S.C. Chihuahua
Mexico Instituto de Diabetes, Obesidad y Nutrición S.C. Cuautla Morelos
Mexico Cardiologia Clinica e Intervencionista Guadalajara Jalisco
Mexico Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C. Madero Tamaulipas
Mexico Centro de Atención e Investigación en Factores de Riesgo Cardiovascular Omega S.C. Mexico Distrito Federal
Mexico Health Pharma Professional Research S.A. de C.V. Mexico Distrito Federal
Mexico Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran Mexico Distrito Federal
Mexico Mentrials S.A. de C.V. Mexico Distrito Federal
Mexico Phytomedicamenta S.A. de C.V. Mexico Distrito Federal
Mexico Centro Medico San Francisco Monterrey Nuevo León
Mexico Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey Nuevo León
Mexico Centro Integral Medico SJR S.C. San Juan del Rio Queretaro
Mexico Unidad Medica para la Salud Integral San Nicolas de los Garza Nuevo León
Mexico Centro de Investigacion Cardiovascular y Metabolica Tijuana Baja California Norte
Mexico Sociedad de Metabolismo y Corazon S.C Veracruz
Mexico Centro de Investigacion Medica de Occidente, S.C. Zapopan Jalisco
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Ziekenhuisgroep Twente, Almelo Almelo
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Poland NZOZ Centrum Medyczne KERmed Bydgoszcz
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Russian Federation TSHI "Altay Territorial Cardiologocal dispensary" Barnaul
Russian Federation SEIHPE "Ural SMA of RosZdrav" b.o. LLC "City Hospital #41" Ekaterinburg
Russian Federation FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease" Kemerovo
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Russian Federation TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich Krasnoyarsk
Russian Federation FSBI "Central Clinical Hospital with Polyclinic of the Department for Presidential Affairs of the RF Moscow
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Russian Federation SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov" of the MoH of the RF Moscow
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Russian Federation SBHI "City Polyclinic #2 of Healthcare department of city of Moscow" Moscow
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Russian Federation FSBI "Research Institute for Cardiology" of Siberian Branch RAMS Tomsk
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Slovakia Diabetes centrum, s.r.o. Trencin
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South Africa Cardiology Clinical Research Alberton Gauteng
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South Africa Groote Schuur Hospital Lipid Laboratory Cape Town Western Cape
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South Africa Limpopo Clinical Research Initiative Thabazimbi Limpopo
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Ukraine CI Cherkasy RH of Cherkasy Regional Council Cherkasy
Ukraine CMI CCH#3 Dep of Ther# w the beds of card profile HSEI of UBSMU Chernivtsi
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Ukraine Railway Transport Kharkiv CH #1 of Healthcare Center Branch of PJSC Ukr Railway Kharkiv
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Ukraine Department of Medical Services and Rehabilitation of State Joint Stock Holding Company Artem Kyiv
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Ukraine Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC Kyiv
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Ukraine Center of Reconstructive & Restorative Medicine (University Clinic) of Odessa National Medical Uni Odesa
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United Kingdom Synexus Birmingham Clinical Research Centre Birmingham West Midlands
United Kingdom Waterloo Medical Centre Blackpool Lancashire
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United Kingdom Broomfield Hospital Chelmsford Essex
United Kingdom Synexus Lancashire Clinical Research Centre Chorley Lancashire
United Kingdom Ninewells Hospital Dundee Tayside Region
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United Kingdom Mounts Bay Medical Ltd Hayle Cornwall
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United Kingdom Oak Tree Surgery Liskeard Cornwall
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United Kingdom Barts Hospital London Greater London
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United States Synexus Clinical Research US, Inc. Akron Ohio
United States Endocrine Group, L.L.P. Albany New York
United States Stratton Veterans Affairs Medical Center - Albany Albany New York
United States Raymond G. Murphy VA Medical Center Albuquerque New Mexico
United States Cambridge Medical Trials Alexandria Louisiana
United States Clinical Research Alliance, Inc Alhambra California
United States Community Hospital of Anderson and Madison County, Inc. Anderson Indiana
United States Synexus Clinical Research US, Inc. Anderson South Carolina
United States University of Michigan Ann Arbor Michigan
United States Veterans Affairs Ann Arbor Healthcare System Ann Arbor Michigan
United States Randolph Medical Associates Asheboro North Carolina
United States OnSite Clinical Solutions, LLC Asheville North Carolina
United States OhioHealth Heart & Vascular Physicians (Heartcare, Inc.) - Athens Athens Ohio
United States Emory University Atlanta Georgia
United States Lynn Institute of Denver Aurora Colorado
United States Central Texas Clinical Research, LLC Austin Texas
United States Baltimore VA medical centre Baltimore Maryland
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United States University of Maryland School of Medicine Baltimore Maryland
United States Bay Pines VA Healthcare System Bay Pines Florida
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United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States Synexus Clinical Research US, Inc. Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
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United States Joslin Diabetes Center Boston Massachusetts
United States Meridien Research Bradenton Florida
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United States PMG Research of Bristol, LLC Bristol Tennessee
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United States Buffalo VA Medical Center Buffalo New York
United States Burke Internal Medicine & Research Burke Virginia
United States Kernodle Clinic, Inc., Dept. of the Private Diagnostic Clinic, PLLC Burlington North Carolina
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United States Aultman Hospital Canton Ohio
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United States Christie Clinic, LLC Champaign Illinois
United States Synexus Clinical Research US, Inc. Chandler Arizona
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United States Novant Health - Heart and Vascular Institute Charlotte North Carolina
United States The Presbyterian Hospital Charlotte North Carolina
United States Chattanooga Medical Research, LLC Chattanooga Tennessee
United States Chattanooga Research and Medicine (CHARM) Chattanooga Tennessee
United States University Diabetes & Endocrine Consultants Chattanooga Tennessee
United States WR-ClinSearch, LLC Chattanooga Tennessee
United States Virginia Endocrinology Research Chesapeake Virginia
United States Apex Medical Research, AMR, Inc. Chicago Illinois
United States Cincinnati Veterans Affairs Medical Center Cincinnati Ohio
United States Hometown Urgent Care & Occupational Health Cincinnati Ohio
United States Clearwater Cardiovascular Consultants Clearwater Florida
United States Louis Stokes Cleveland Dept of VA Medical Center Cleveland Ohio
United States Aurora Care Clinic Costa Mesa California
United States West Broadway Clinic Council Bluffs Iowa
United States Cardiovascular Associates Research, LLC Covington Louisiana
United States Partners in Clinical Research Cumberland Rhode Island
United States Atlanta Heart Specialists, LLC Cumming Georgia
United States North Texas Endocrine Center Dallas Texas
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United States Research Institute of Dallas, P.A. Dallas Texas
United States Synexus Clinical Research US, Inc. Dallas Texas
United States VA Medical Center - Dallas Dallas Texas
United States Daytona Heart Group Daytona Beach Florida
United States VA Medical Center - Atlanta Decatur Georgia
United States Cohen Medical Research Associates, LLC Delray Beach Florida
United States Iowa Diabetes and Endocrinology Research Center, PLC Des Moines Iowa
United States Alta Pharmaceutical Research Center, Inc. Dunwoody Georgia
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United States Doctors Hospital at Renaissance Edinburg Texas
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United States Utah Cardiology, P.C. (Davis) Farmington Utah
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United States AA MRC LLC Ahmed Arif Medical Research Center Flint Michigan
United States Diabetes and Thyroid Center of Fort Worth Fort Worth Texas
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United States Texas Health Physicians Group Fort Worth Texas
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United States University of North Texas Health Science Center Fort Worth Texas
United States Prestige Clinical Research Center Franklin Ohio
United States Malcom Randall VA Medical Center Gainesville Florida
United States New West Physicians, PC Golden Colorado
United States Cardiology Associates of Bellin Health Green Bay Wisconsin
United States Medication Management, LLC Greensboro North Carolina
United States Triad Clinical Trials, LLC Greensboro North Carolina
United States Mountain View Clinical Research, Inc. Greer South Carolina
United States Fundamental Research, LLC Gulf Shores Alabama
United States Clinical Investigation Specialists, Inc. Gurnee Illinois
United States Pentucket Medical Associates Haverhill Massachusetts
United States Synexus Clinical Research US, Inc. Henderson Nevada
United States Clinical Trials of America-NC, LLC Hickory North Carolina
United States PMG Research of Hickory, LLC Hickory North Carolina
United States Edward Hines Jr. VA Hospital Hines Illinois
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United States Homestead Cardiac & Vein Center Homestead Florida
United States Associates in Medicine Houston Texas
United States East Texas Cardiology PA Houston Texas
United States Endocrine Associates, LLC Houston Texas
United States Heights Doctors Clinic Houston Texas
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United States National Institute of Clinical Research Huntington Beach California
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United States Medstar Health Research Institute Hyattsville Maryland
United States Piedmont Research Partners Indian Land South Carolina
United States VA Medical Center - Indianapolis Indianapolis Indiana
United States GV Montgomery VA Medical Center Jackson Mississippi
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Westside Center for Clinical Research Jacksonville Florida
United States Health Awareness, Inc. Jupiter Florida
United States Kalispell Regional Medical Center dba Glacier View Research Institute Kalispell Montana
United States Kansas City VA Medical Center Kansas City Missouri
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States Clinical Investigation Specialists Inc Kenosha Wisconsin
United States Holston Medical Group, P.C. Kingsport Tennessee
United States Metro Knoxville HMA, LLC Knoxville Tennessee
United States Mayo Clinic Health System La Crosse Wisconsin
United States Centex Studies Inc. Lake Charles Louisiana
United States Meridien Research Lakeland Florida
United States Sparrow Clinical Research Institute Lansing Michigan
United States Clearwater Cardiovascular & Interventional Consultants Largo Florida
United States Red Rock Clinical Research LLC Las Vegas Nevada
United States VA Eastern Kansas Health Care Leavenworth Kansas
United States Family Medical Associates Levittown Pennsylvania
United States The Research Group of Lexington, LLC Lexington Kentucky
United States Ocean State Clinical Research Partners Lincoln Rhode Island
United States NJ Heart Linden New Jersey
United States Main Street Physician's Care - Waterway Little River South Carolina
United States Central Arkansas Veterans Healthcare System Little Rock Arkansas
United States Southwest Family Medicine Littleton Colorado
United States VA Loma Linda Healthcare System Loma Linda California
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United States Eastside Clinical Research Associates Los Angeles California
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States Richard S. Cherlin, MD Los Gatos California
United States Robley Rex VA Medical Center Louisville Kentucky
United States Meriter Medical Group, Inc. Madison Wisconsin
United States Carient Heart and Vascular Manassas Virginia
United States Craig S Thompson MD LLC Marion Ohio
United States Heart Clinic of Southern Oregon Medford Oregon
United States VA Medical Center - Memphis Memphis Tennessee
United States Synexus Clinical Research US, Inc. Mesa Arizona
United States Advanced Medical Research Institute Miami Florida
United States University of Miami Miami Florida
United States South Shore Internal Medicine Associates Milton Massachusetts
United States Zablocki VA Medical Center Milwaukee Wisconsin
United States Winthrop Cardiology Associates Mineola New York
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Mobile Heart Specialists, PC Mobile Alabama
United States Research Institute of the Carolinas, PLC Mooresville North Carolina
United States Diabetes and Endocrinology Consultants Morehead City North Carolina
United States Cardiovascular Research of Northwest Indiana, LLC Munster Indiana
United States Family Medicine of Sayebrook Myrtle Beach South Carolina
United States Southern New Hampshire Diabetes and Endocrinology Nashua New Hampshire
United States Tennessee Valley Healthcare System Nashville Tennessee
United States Icahn School of Medicine at Mount Sinai New York New York
United States Cardiology Physicians, PA Newark Delaware
United States Advocate Health and Hospitals Corp Normal Illinois
United States Intend Research Norman Oklahoma
United States Lynn Institute of Norman Norman Oklahoma
United States Captain James A. Lovell Federal Health Care Center North Chicago Illinois
United States Northridge Clinical Research Inc. Northridge California
United States Morgan Medical Management & Consultants Inc. Ocala Florida
United States Ocala Research Institute, Inc. Ocala Florida
United States Endocrine Associates of Florida Ocoee Florida
United States Oklahoma City Clinic - Central Oklahoma City Oklahoma
United States South Oklahoma Heart Research Group Oklahoma City Oklahoma
United States Specialty Physicians of Illinois Olympia Fields Illinois
United States University of Nebraska Medical Center Omaha Nebraska
United States VA Nebraska-Western Iowa Health Care System Omaha Nebraska
United States Research Physicians Network Alliance Orlando Florida
United States Palo Alto Division Palo Alto California
United States Synexus Clinical Research US, Inc. Papillion Nebraska
United States Huntington Hospital - Research Department Pasadena California
United States Houston Methodist Research Institute - CCAT Pearland Pearland Texas
United States Andres Patron, D.O., P.A Pembroke Pines Florida
United States DBC Research, Corp Pembroke Pines Florida
United States Langhorne Cardiology Consultants, Inc. Pensacola Florida
United States Arizona Arthritis & Rheumatology Research, PLLC Peoria Arizona
United States Phoenix Veterans Adminstration Health Care System Phoenix Arizona
United States Synexus Clinical Research US, Inc. Phoenix Arizona
United States Pinehurst Medical Clinic Inc Pinehurst North Carolina
United States Preferred Primary Care Physicians Pittsburgh Pennsylvania
United States VA Pittsburgh Healthcare System Pittsburgh Pennsylvania
United States Clinical Investigations of Texas Plano Texas
United States Providence Veteran Administration Medical Center Providence Rhode Island
United States PMG Research of Raleigh, LLC Raleigh North Carolina
United States Rancho Cucamonga Clinical Research Rancho Cucamonga California
United States VA Sierra Nevada Health Care System Reno Nevada
United States Synexus Clinical Research US, Inc. Richfield Minnesota
United States Clinical Research Partners, LLC Richmond Virginia
United States McGuire DVA Medical Center Richmond Virginia
United States The Valley Hospital Ridgewood New Jersey
United States Roanoke Heart Institute Roanoke Virginia
United States PMG Research of Rocky Mount, LLC Rocky Mount North Carolina
United States Clearwater Cardiovascular Consultants Safety Harbor Florida
United States Covenant Medical Center, Inc. Saginaw Michigan
United States CentraCare Heart & Vascular Saint Cloud Minnesota
United States Synexus Clinical Research US, Inc. Saint Louis Missouri
United States HealthEast Medical Research Institute Saint Paul Minnesota
United States Professional Health Care of Pinellas Saint Petersburg Florida
United States Delmarva Heart Research Foundation, Inc. Salisbury Maryland
United States PMG Research of Salisbury, LLC Salisbury North Carolina
United States Bandera Family Healthcare Research LLC San Antonio Texas
United States Briggs Clinical Research, LLC. San Antonio Texas
United States Consano Clinical Research, LLC San Antonio Texas
United States Sant Antonio Premiere Internal Medicine San Antonio Texas
United States Schnitzler Cardiovascular Consultants (SCC), PLLC San Antonio Texas
United States MD Strategies Research Centers San Diego California
United States Alex Harrison, MD Inc. Santa Maria California
United States Santa Rosa Cardiology Medical Group, Inc. Santa Rosa California
United States Northeast Clinical Research of San Antonio Schertz Texas
United States Fay West Family Practice Scottdale Pennsylvania
United States Carolina Research Center, Inc. Shelby North Carolina
United States Overton Brooks VA Medical Center Shreveport Louisiana
United States Montgomery Medical Inc. Smithfield Pennsylvania
United States Palmetto Research Center, LLC Spartanburg South Carolina
United States Spring Family Practice Associates Spring Texas
United States Suffolk Multispecialty Research Suffolk Virginia
United States Palmetto Clinical Research Summerville South Carolina
United States Clinical Research Institute of Arizona, LLC Surprise Arizona
United States SUNY Upstate Medical University Syracuse New York
United States VA Medical Center - Syracuse Syracuse New York
United States James A. Haley VA Medical Center Tampa Florida
United States Northwest Houston Heart Center Tomball Texas
United States Atlanta Heart Specialists, LLC Tucker Georgia
United States Eclipse Clinical Research Tucson Arizona
United States Synexus Clinical Research US, Inc. Tucson Arizona
United States Terence T. Hart, MD Tuscumbia Alabama
United States Buynak Clinical Research Valparaiso Indiana
United States Victoria Heart & Vascular Center Victoria Texas
United States Corporation Lane Internal Medicine Virginia Beach Virginia
United States Blue Coast Cardiology Vista California
United States Hillcrest Family Health Clinics Waco Texas
United States Chase Medical Research, LLC Waterbury Connecticut
United States The Iowa Clinic, PC West Des Moines Iowa
United States VA Connecticut Healthcare Sys West Haven Connecticut
United States VA Medical Center White River Junction Vermont
United States Clinical Research of Central Florida Winter Haven Florida

Sponsors (2)

Lead Sponsor Collaborator
Kowa Research Institute, Inc. Brigham and Women's Hospital

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Colombia,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Japan,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with first occurrence of nonfatal MI, nonfatal ischemic stroke, coronary revascularization, or CV death. Through study completion, an average of 4 years
Secondary Time to first occurrence of The 4-component composite endpoint of non-fatal MI, non-fatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization or cardiovascular death Through study completion, an average of 4 years
Secondary Time to first occurrence of the 3-component composite endpoint of non-fatal MI, non-fatal ischemic stroke, or cardiovascular death Through study completion, an average of 4 years
Secondary Time to first occurrence of any component of the primary endpoint or hospitalization for Heart failure (HF) Through study completion, an average of 4 years
Secondary Time to first occurrence of any component of the primary endpoint or all-cause mortality Through study completion, an average of 4 years
Secondary Time to first occurrence of any new or worsening Peripheral artery disease (PAD) Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index = 0.9 or other diagnostic testing (eg, toe-brachial index, angiogram, or other imaging study) Through study completion, an average of 4 years
Secondary Time of first occurrence of individual endpoints and an analysis of total events (evaluating time to occurrence of the first and all recurrent non-fatal MI, non-fatal ischemic stroke, coronary revascularization, or cardiovascular death). Through study completion, an average of 4 years
Secondary Incidence of cardiovascular events Effect of pemafibrate vs placebo on cardiovascular events compared to known genetic polymorphisms in the PPARA gene Up to 4 Years
Secondary Lipid Endpoints The change from Screening/Enrollment Visit (Visit 1) to Month 4 Visit (Visit 5) for the following lipid biomarkers: Total cholesterol (TC), Triglyceride(s) (TG), High-density lipoprotein cholesterol (HDL-C), non-HDL-C (calculated), Very low-density lipoprotein cholesterol (VLDL-C) (calculated), ApoA1, ApoC3, and ApoE Week -3 to Month 4 (Visit 1 to Visit 5)
Secondary Nonfasting Remnant Cholesterol Endpoint The change from Randomization Visit (Visit 2) to Month 6 Visit (Visit 6) for nonfasting remnant cholesterol Week 0 to Month 6 (Visit 2 to Visit 6)
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