Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) (PROMINENT)
Type2 Diabetes, Dyslipidemia
About this trial
This is an interventional prevention trial for Type2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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)
- HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
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
- Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
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:
- Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
- Known sensitivity to PPAR-α agonists or tablet excipients
- 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
- Type 1 diabetes mellitus
Sites / Locations
- Synexus Clinical Research US, Inc.
- University of Alabama at Birmingham
- VA Medical Center - Birmingham
- Alabama Clinical Therapeutics, LLC
- Fundamental Research, LLC
- Mobile Heart Specialists, PC
- Terence T. Hart, MD
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc.
- Arizona Arthritis & Rheumatology Research, PLLC
- Phoenix Veterans Adminstration Health Care System
- Synexus Clinical Research US, Inc.
- Clinical Research Institute of Arizona, LLC
- Synexus Clinical Research US, Inc.
- Eclipse Clinical Research
- Central Arkansas Veterans Healthcare System
- Clinical Research Alliance, Inc
- Aurora Care Clinic
- AMCR Institute, Inc.
- National Institute of Clinical Research
- VA Loma Linda Healthcare System
- VA Long Beach Healthcare System
- Eastside Clinical Research Associates
- VA Greater Los Angeles Healthcare System
- Richard S. Cherlin, MD
- Northridge Clinical Research Inc.
- Palo Alto Division
- Huntington Hospital - Research Department
- Rancho Cucamonga Clinical Research
- MD Strategies Research Centers
- Alex Harrison, MD Inc.
- Santa Rosa Cardiology Medical Group, Inc.
- Blue Coast Cardiology
- Lynn Institute of Denver
- New West Physicians, PC
- Southwest Family Medicine
- Chase Medical Research, LLC
- VA Connecticut Healthcare Sys
- Cardiology Physicians, PA
- Bay Pines VA Healthcare System
- Meridien Research
- Clinical Research Of Brandon, LLC
- Clearwater Cardiovascular Consultants
- Daytona Heart Group
- Cohen Medical Research Associates, LLC
- Malcom Randall VA Medical Center
- Pines Clinical Research, Inc.
- Homestead Cardiac & Vein Center
- Westside Center for Clinical Research
- Jacksonville Center for Clinical Research
- Health Awareness, Inc.
- Meridien Research
- Clearwater Cardiovascular & Interventional Consultants
- University of Miami
- Advanced Medical Research Institute
- Ocala Research Institute, Inc.
- Morgan Medical Management & Consultants Inc.
- Endocrine Associates of Florida
- Research Physicians Network Alliance
- Andres Patron, D.O., P.A
- DBC Research, Corp
- Langhorne Cardiology Consultants, Inc.
- Clearwater Cardiovascular Consultants
- Professional Health Care of Pinellas
- James A. Haley VA Medical Center
- Clinical Research of Central Florida
- Emory University
- Atlanta Heart Specialists, LLC
- VA Medical Center - Atlanta
- Alta Pharmaceutical Research Center, Inc.
- Atlanta Heart Specialists, LLC
- Christie Clinic, LLC
- Apex Medical Research, AMR, Inc.
- Clinical Investigation Specialists, Inc.
- Edward Hines Jr. VA Hospital
- Advocate Health and Hospitals Corp
- Captain James A. Lovell Federal Health Care Center
- Specialty Physicians of Illinois
- Community Hospital of Anderson and Madison County, Inc.
- Synexus Clinical Research US, Inc.
- Deaconess Clinic
- VA Medical Center - Indianapolis
- Cardiovascular Research of Northwest Indiana, LLC
- Buynak Clinical Research
- West Broadway Clinic
- Iowa Diabetes and Endocrinology Research Center, PLC
- The Iowa Clinic, PC
- University of Kansas Medical Center Research Institute, Inc.
- VA Eastern Kansas Health Care
- The Research Group of Lexington, LLC
- Robley Rex VA Medical Center
- Cambridge Medical Trials
- Cardiovascular Associates Research, LLC
- Centex Studies Inc.
- Overton Brooks VA Medical Center
- Southern Maine Health Care
- Baltimore VA medical centre
- University of Maryland School of Medicine
- Maryland Cardiovascular Specialists
- Medstar Health Research Institute
- Delmarva Heart Research Foundation, Inc.
- Joslin Diabetes Center
- Pentucket Medical Associates
- South Shore Internal Medicine Associates
- University of Michigan
- Veterans Affairs Ann Arbor Healthcare System
- Northern Pines Health Center
- Cadillac Clinical Research, LLC
- AA MRC LLC Ahmed Arif Medical Research Center
- Sparrow Clinical Research Institute
- Covenant Medical Center, Inc.
- Minneapolis Heart Institute Foundation
- Synexus Clinical Research US, Inc.
- CentraCare Heart & Vascular
- HealthEast Medical Research Institute
- GV Montgomery VA Medical Center
- Kansas City VA Medical Center
- Synexus Clinical Research US, Inc.
- Kalispell Regional Medical Center dba Glacier View Research Institute
- VA Nebraska-Western Iowa Health Care System
- University of Nebraska Medical Center
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc.
- Red Rock Clinical Research LLC
- VA Sierra Nevada Health Care System
- Southern New Hampshire Diabetes and Endocrinology
- Monmouth Cardiology Associates
- NJ Heart
- The Valley Hospital
- Raymond G. Murphy VA Medical Center
- Endocrine Group, L.L.P.
- Stratton Veterans Affairs Medical Center - Albany
- Buffalo VA Medical Center
- Winthrop Cardiology Associates
- Icahn School of Medicine at Mount Sinai
- SUNY Upstate Medical University
- VA Medical Center - Syracuse
- Randolph Medical Associates
- OnSite Clinical Solutions, LLC
- Kernodle Clinic, Inc., Dept. of the Private Diagnostic Clinic, PLLC
- Cary Research Group, LLC
- PMG Research of Cary, LLC
- Novant Health - Heart and Vascular Institute
- The Presbyterian Hospital
- Focus Clinical Research Solutions
- Medication Management, LLC
- Triad Clinical Trials, LLC
- Clinical Trials of America-NC, LLC
- PMG Research of Hickory, LLC
- Research Institute of the Carolinas, PLC
- Diabetes and Endocrinology Consultants
- Pinehurst Medical Clinic Inc
- PMG Research of Raleigh, LLC
- PMG Research of Rocky Mount, LLC
- PMG Research of Salisbury, LLC
- Carolina Research Center, Inc.
- Synexus Clinical Research US, Inc.
- OhioHealth Heart & Vascular Physicians (Heartcare, Inc.) - Athens
- Aultman Hospital
- Hometown Urgent Care & Occupational Health
- Cincinnati Veterans Affairs Medical Center
- Louis Stokes Cleveland Dept of VA Medical Center
- Prestige Clinical Research Center
- Craig S Thompson MD LLC
- Intend Research
- Lynn Institute of Norman
- Oklahoma City Clinic - Central
- South Oklahoma Heart Research Group
- Heart Clinic of Southern Oregon
- Chambersburg Hospital
- AMH Feasterville Family Health Care Center
- Family Medical Associates
- VA Pittsburgh Healthcare System
- Preferred Primary Care Physicians
- Fay West Family Practice
- Montgomery Medical Inc.
- Partners in Clinical Research
- Ocean State Clinical Research Partners
- Providence Veteran Administration Medical Center
- Synexus Clinical Research US, Inc.
- Ralph H. Johnson VA Medical Center
- Mountain View Clinical Research, Inc.
- Piedmont Research Partners
- Main Street Physician's Care - Waterway
- Family Medicine of Sayebrook
- Palmetto Research Center, LLC
- Palmetto Clinical Research
- PMG Research of Bristol, LLC
- Chattanooga Medical Research, LLC
- Chattanooga Research and Medicine (CHARM)
- University Diabetes & Endocrine Consultants
- WR-ClinSearch, LLC
- Holston Medical Group, P.C.
- Metro Knoxville HMA, LLC
- VA Medical Center - Memphis
- Tennessee Valley Healthcare System
- Central Texas Clinical Research, LLC
- Protenium Clinical Research
- VA Medical Center - Dallas
- North Texas Endocrine Center
- Research Institute of Dallas, P.A.
- Synexus Clinical Research US, Inc.
- Doctors Hospital at Renaissance
- Texas Health Research & Education Institute
- Texas Health Physicians Group
- University of North Texas Health Science Center
- Diabetes and Thyroid Center of Fort Worth
- Rockwood Medical Clinic
- East Texas Cardiology PA
- Endocrine Associates, LLC
- Heights Doctors Clinic
- Associates in Medicine
- Michael E. DeBakey VA Medical Center
- Southwest Clinical Trials
- Protenium Clinical Research
- Houston Methodist Research Institute - CCAT Pearland
- Clinical Investigations of Texas
- Consano Clinical Research, LLC
- Sant Antonio Premiere Internal Medicine
- Briggs Clinical Research, LLC.
- Schnitzler Cardiovascular Consultants (SCC), PLLC
- Bandera Family Healthcare Research LLC
- Northeast Clinical Research of San Antonio
- Spring Family Practice Associates
- Northwest Houston Heart Center
- Victoria Heart & Vascular Center
- Hillcrest Family Health Clinics
- Utah Cardiology, P.C. (Davis)
- VA Medical Center
- Burke Internal Medicine & Research
- Virginia Endocrinology Research
- Carient Heart and Vascular
- Clinical Research Partners, LLC
- McGuire DVA Medical Center
- Roanoke Heart Institute
- Suffolk Multispecialty Research
- Corporation Lane Internal Medicine
- Cardiology Associates of Bellin Health
- Clinical Investigation Specialists Inc
- Mayo Clinic Health System
- Meriter Medical Group, Inc.
- Zablocki VA Medical Center
- Hospital Interzonal General de Agudos Dr Jose Penna
- Hospital Italiano Regional del Sur
- Hospital Italiano
- CICLO
- Centro de Investigaciones Medicas Mar del Plata
- Instituto de Investigaciones Clinicas
- Instituto de Investigaciones Clinicas San Nicolas
- Instituto Clinico Metabolico
- Clinica Olivos
- Hospital Sirio Libanes
- Sanatorio Güemes
- Centro Medico Viamonte SRL
- CEMEDIC - Centro de Especialidades Medicas
- Centro Medico Luquez
- Axismed S.R.L.- Clínica Mayo
- Consultorio Dr. Litvak Bruno
- Fundacion Favaloro
- CIPREC
- Investigaciones Medicas IMOBA S.R.L
- Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
- CEDIC Centro de Investigaciones Clinicas
- Instituto Cardiovascular Buenos Aires
- CCBR - Buenos Aires - AR
- Inst. Privado de Inv. Clinicas de Cordoba
- Instituto Medico DAMIC
- Hospital Privado Centro Medico de Cordoba S.A
- Clinica del Prado
- Instituto de Cardiologia de Corrientes
- Prevencion Cardiovascular Salta
- L2IP - Instituto de Pesquisas Clínicas Ltda.
- Hospital do Coração do Brasil
- CECAP - Centro de Cardiologia Clínica
- Hospital Universitário de Brasília
- Clínica de Endocrinologia e Metabologia Ltda.
- CARDIOINTERV Centro de Pesquisa S/S
- Via Médica
- HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
- Hospital Felício Rocho
- CARDRESEARCH - Cardiologia Assistencial
- Sociedade Hospitalar Angelina Caron
- Cline Research Center (Leite PS Consultoria Medica LTDA)
- Núcleo de Pesquisa Clínica S/S
- Paraná Medical Research Center
- HUJBB-UFPA - Hospital Universitário João de Barros Barreto - Universidade Federal do Pará
- CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
- Eurolatino Natal Pesquisas Médicas Ltda.
- Hospital Universitário
- Hospital São Vicente de Paulo
- Santa Casa de Misericórdia de Pelotas
- Santa Casa de Misericórdia de Porto Alegre
- Hospital de Clínicas de Porto Alegre
- Centro de Pesquisas em Diabetes Ltda.
- Centro de Pesquisa Clínica Maimônides - Maimônides Day Hospital
- Centro de Pesquisa Médica Santa Maria Ltda.
- Maestri e Kormann Consultoria Medico Científica LTDA
- Loema - Instituto de Pesquisa Clínica
- IPCC - Instituto de Pesquisa Clínica de Campinas
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
- ISPEM - Instituto São José dos Campos em Pesquisas Médicas
- CPQuali Pesquisa Clínica Ltda.
- CPCLIN - Centro de Pesquisas Clínicas Ltda.
- Clínica Paulista de Doenças Cardiovasculares Ltda.
- Dr. Consulta
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
- Hospital das Clínicas da Faculdade de Medicina da USP
- Incor - Instituto do Coração - HCFMUSP
- IMC - Instituto de Moléstias Cardiovasculares Tatuí
- Santa Casa de Votuporanga
- MHAT 'Puls' AD
- MHAT - Blagoevgrad, EOOD
- MHAT "Yuliya Vrevska - Byala", EOOD
- MHAT-Haskovo, AD
- MHAT "Higia", AD - Pazardzhik
- MHAT - Pazardzhik AD
- MHAT "Sv. Pantaleymon - Pleven", OOD
- SHATC Pleven EAD
- UMHAT 'Dr. Georgi Stranski', EAD
- UMHAT "Sv. Georgi", EAD
- UMHAT "Kaspela", EOOD
- MC Rusemed ltd.
- Diagnostic Consultative Center II - Sofia OOD
- Fifth MHAT - Sofia EAD
- NMTH "Tsar Boris III"
- MHAT - "National Heart Hospital" EAD
- MHAT "Lyulin", EAD
- Acibadem City Clinic Tokuda Hospital Ead
- MC Start - d-r Todor Dimitrov EOOD
- DCC "Alexandrovska", EOOD
- UMHAT "Alexandrovska" EAD
- UMHAT 'Tsaritsa Yoanna - ISUL', EAD
- Fourth MHAT - Sofia EAD
- Diagnostic Consultation Center CONVEX EOOD
- Medical Center Kalimat
- UMHAT 'Sveta Anna' AD
- MC "Synexus - Sofia", EOOD
- UMHAT "SofiaMed", OOD
- MC "Orfey", EOOD
- SHATC "Cardiolife", OOD
- SHATC - Varna, EOOD
- MHAT "Sv. Panteleymon", AD
- LMC Clinical Research Inc. (Calgary)
- ALTA Clinical Research Inc.
- Royal Alexandra Hospital, CK Hui Heart Centre
- The Bailey Clinic
- Fraser Clinical Trials Inc.
- Surrey Memorial Hospital
- BC Diabetes As Operated by Dr. TG Elliott, Inc.
- Discovery Clinical Services Ltd.
- Saint Boniface General Hospital
- Rivergrove Medical Clinic
- Winnipeg Clinic
- Health Sciences Centre
- LMC Clinical Research Inc. (Barrie)
- LMC Clinical Research Inc. (Brampton)
- Aggarwal and Associates Ltd
- JBN Medical Diagnostic Services Inc.
- LMC Clinical Research dba Manna Research Inc. Burlington North
- Cambridge Cardiac Care Centre
- Joanne F. Liutkus Medicine Professional Corporation
- Saul Vizel Professional Medicine Corporation
- LMC Clinical Research Inc. (Thornhill)
- LMC Clinical Research Inc. (Etobicoke)
- Dawson Road Family Medical Clinic
- LMC Clinical Research Inc. (Ottawa)
- LMC Clinical Research Inc. (Oakville)
- James Cha, MD
- The Ottawa Hospital - Riverside Campus
- Kawartha Cardiology Clinical Trials
- Scarborough Cardiology Research
- Janik Research
- Humber River Hospital
- LMC Clinical Research Inc. (Bayview)
- St. Michael's Hospital
- LMC Clinical Research dba Manna Research Inc. Toronto
- Ecogene-21
- ViaCar Recherche Clinique Inc
- Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud
- Clinique de Cardiologie de Levis
- LMC Clinical Research dba Manna Research Inc. Mirabel
- CHUM Hôtel-Dieu
- Applied Medical Informatics Research Inc.
- Clinique Santé Cardio MC
- Recherche Clinique Sigma Inc.
- Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis
- ALPHA Recherche Clinique
- LMC Clinical Research Inc. (Montreal)
- Recherche Médicale St-Jérôme Inc.
- Centre Medical des Carrieres
- DIEX Recherche Quebec Inc.
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Clinique des maladies Lipidiques de Quebec
- Centro de Investigacion Medico Asistencial S.A.S
- IPS Centro Cientifico Asistencial S.A.S
- Dexa Diab Servicios Médicos Limitada.
- Solano y Terront Servicios Médicos Ltda.
- Centro Cardiovascular Aristides Sotomayor Santa Lucia S.A.S. - IPS ASTALUC S.A.S. IPS
- Fundación Centro de Investigaciones Biomédicas Riescard
- Fundación Oftalmológica de Santander - FOSCAL
- Centro de Investigación Clínica CIC
- Medicentrum Beroun spol. s.r.o.
- Nemocnice Milosrdnych bratri
- Fakultni nemocnice u sv. Anny v Brne
- EDUMED s.r.o
- Poliklinika Chocen a.s.
- Ordinace pro choroby srdce s.r.o.
- MUDr. Jan Hubac s.r.o.
- Nemocnice Havlickuv Brod p.o.
- Kardio-Pisova s.r.o.
- MUDr. Tomas Edelsberger
- EDUMED s.r.o
- Agentura Science Pro Spol. s.r.o.
- PreventaMed s.r.o.
- CCR Ostrava s.r.o.
- Corintez s.r.o.
- MUDr. Jan KVASNICKA CSc. Angiologie kardiologie a interna
- Nemocnice na Frantisku
- Vseobecna fakultni nemocnice v Praze
- ResTrial s.r.o.
- Synexus Czech s.r.o.
- MUDr.Eva Mandakova MBA
- Nemocnice Slany
- AeskuLab k.s.
- Kardiologicka ambulance MUDr. Ferkl s.r.o.
- Clinical Trials Services s.r.o
- MUDr. Nina Zemkova s.r.o.
- Bioclinica
- Ålborg Universitets Hospital
- Aarhus University Hospital
- Bioclinica
- Amager-Hvidovre Hospital
- Sydvestjyds Sygehus Esbjerg
- Amager-Hvidovre Hospital
- Herlev og Gentofte Hospital
- Herlev og Gentofte Hospital
- Regionshospitalet Herning-Hospitalsenheden Vest
- Holbæk Sygehus
- Sjællands Universitetshospital
- OUH
- Bioclinica
- CHU Tours - Hôpital Trousseau
- CHU Nantes - Hopital Nord Laënnec
- Hôpital Bichat - Claude Bernard
- Universitaetsklinikum Freiburg
- Praxis fuer Praevention und Therapie
- Gemeinschaftspraxis Dr. Klein/ Minnich
- Klinikum der Universitaet Muenchen
- Deutsches Herzzentrum Muenchen
- GP Dr. Haggenmiller, PD Dr. Michael Jeserich
- ZKS-Südbrandenburg -center for clinical studies Südbrandenburg GmbH
- Neurologische Praxis Dr. Schoell & Kollegen
- Synexus Clinical Research GmbH
- ClinPhenomics GmbH & Co KG
- Klinische Forschung Schwerin GmbH
- Synexus Clinical Research GmbH
- Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch
- Kardiologische Praxis Gemeinschaftspraxis
- St. Johannes Hospital
- Klinikum Bielefeld gem. GmbH
- Zentrum fuer Praevention und Rehabilitation
- Synexus Clinical Research GmbH
- Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
- Dr. Uwe Böckmann / Birgit Jacobs - Diabeteszentrum Neumünster
- RED - Institut GmbH
- Katholisches Krankenhaus "St. Johann Nepomuk"
- Diabetespraxis Prenzlauer Allee
- Institut fuer klinische Forschung und Entwicklung Berlin GmbH
- Studienzentrum Rankestrasse
- Synexus Clinical Research GmbH
- Gemeinschaftspraxis fuer innere Medizin und Diabetologie
- Lausmed Kft.
- Principal SMO Kft.
- DRC Gyogyszervizsgalo Kozpont Kft.
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
- Belgyogyaszati es Kardiologiai Maganrendelo
- Clinexpert Kft.
- Synexus Magyarorszag Kft.
- CSALADGYOGYASZ Kft.
- Semmelweis Egyetem
- Borvo Clinic Kft.
- Debreceni Egyetem
- Meditoll Kft.
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
- Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Gyula DRS
- BKS Research Kft.
- Z+P MED Egeszsegugyi, Kereskedelmi es Szolgaltato Bt.
- Somogy Megyei Kaposi Mor Oktato Korhaz
- Selye Janos Korhaz
- IPR Hungary Kft.
- Kanizsai Dorottya Korhaz
- Medifarma-98 Kft.
- BORBANYA PRAXIS Kft.
- Dr. Nagy Laszlo Kardiologiai Maganrendeles
- Da Vinci Maganklinika
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Tolna Megyei Balassa Janos Korhaz
- Csolnoky Ferenc Korhaz
- Zala Megyei Szent Rafael Korhaz
- Vijaya Super Speciality Hospital
- GNRC Hospital
- Loknayak Hospital
- Sir Gangaram Hospital
- Fortis Flight Lieutenant Rajan Dhall Hospital
- Ahmedabad Bariatrics and Cosmetics Pvt Ltd.
- S. A. L. Hospital & Medical Institute
- DDMM Heart Institute
- Shri B. D. Mehta Mahavir Heart Institute
- BAPS Pramukhswami Hospital
- Sterling Hospital
- Rhythm Heart Institute
- Medanta The Medicity
- Fortis Hospitals Ltd.
- K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
- JSS Hospital
- Medical College
- Meditrina Institute Of Medical Sciences
- Supe Heart & Diabetes Hospital & Research Centre
- 7-Orange Hospital
- Shree Multispecialty Hospital
- King Edward Memorial Hospital Research Centre
- Aashirwad Hospital
- Institute of Medical Sciences and SUM Hospital
- Eternal Heart Care Centre
- SRM Institutes for Medical Sciences
- Institute of Cardiovascular Diseases Madras Medical Mission
- KRM Hospital & Research Centre
- Galaxy Hospital
- IPGMER and SSKM Hospital
- Maharaja Agrasen Hospital
- HaEmek Medical Center
- Bnai Zion Medical Center
- Rambam Health Care Center
- The Lady Davis Carmel Medical Center
- Wolfson Medical Center
- Shaare Zedek Medical Center
- Hadassah University Hospital - Ein Kerem
- Galilee Medical Center
- Rabin Medical Center-Beilinson Campus
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Ziv Medical Center
- Tel Aviv Sourasky Medical Center
- Diabetes Medical Center
- Aichi Medical University Hospital
- JOHAS Chubu Rosai Hospital
- Kojunkai Daido Clinic
- NHO Nagoya Medical Center
- National Center For Geriatrics And Gerontology
- Fujita Health University Hospital
- Chiba University Hospital
- Kioroshikai Chibanishi General Hospital
- Seikeikai New Tokyo Heart Clinic
- Ehime Prefectural Central Hospital
- Fukuoka University Hospital
- Fukuoka Tokushukai Hospital
- Steel Memorial Yawata Hospital
- NHO Fukuoka Higashi Medical Center
- Chiyukai Fukuoka Shinmizumaki Hospital
- Southern Tohoku Medical Clinic
- Hoshi General Hospital
- Nakahama Heart Clinic
- Nippon Kokan Fukuyama Hospital
- NHO Higashihiroshima Medical Center
- Miyanosawa Clinic of Internal Medicine and Cardiology
- Tanaka Cardiology Clinic
- Nakakinen Clinic Medical Corporation Kensei-kai
- Public Central Hospital of Matto Ishikawa
- NHI Komatsu Municipal Hospital
- Kuonkai Kamata Medical Clinic
- Iwate Medical University Uchimaru Medical Center Hospital
- Josuikai Olive Takamatsu Medical Clinic
- Sohken Yamamoto Clinic
- NHO Yokohama Medical Center
- Kumamoto University Hospital
- Ryubokai Higashi Diabetes and Cardiovascular Clinic
- Ijinkai Takeda General Hospital
- Kyoto University Hospital
- Rakuwakai Otowa Hospital
- Sato Hospital
- Tohoku Kosai Hospital
- Sendai Kousei Hospital
- Keiwakai Oita Oka Hospital
- Okayama University Hospital
- Okinawa Tokushukai Chubu Tokushukai Hospital
- Iwasaki Naika Clinic
- Takekawa Naika Clinic
- Rinku General Medical Center
- Shiraiwa Medical Clinic
- Tokushukai Kishiwada Tokushukai Hospital
- Kansai Electric Power Hospital
- National Cerebral and Cardiovascular Center
- Senrichuo Ekimae Clinic
- IMS Miyoshi General Hospital
- Sugiura Clinic
- Sanyukai Saino Clinic
- NHO Saitama National Hospital
- Shiga University of Medical Science Hospital
- NHO Hamada Medical Center
- Jichi Medical University Hospital
- Juntendo University Hospital
- Fukuwa Clinic
- Tokyo-Eki Center-Building Clinic
- Nomura Clinic
- Hosoda Clinic
- Toyukai Yutenji Medical Clinic (Yutenji Naika)
- Shinjuku Research Park Clinic
- Yamaguchi University Hospital
- Centro de Investigacion Cardiovascular y Metabolica
- Phytomedicamenta S.A. de C.V.
- Health Pharma Professional Research S.A. de C.V.
- Centro de Atención e Investigación en Factores de Riesgo Cardiovascular Omega S.C.
- Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
- Mentrials S.A. de C.V.
- Centro de Investigacion Clinica del Pacifico, S.A. de C.V.
- Cardiologia Clinica e Intervencionista
- Centro de Investigacion Medica de Occidente, S.C.
- Instituto de Diabetes, Obesidad y Nutrición S.C.
- Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
- Centro Medico San Francisco
- Unidad Medica para la Salud Integral
- Centro Integral Medico SJR S.C.
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C.
- Centro de Investigacion Cardiometabolica de Aguascalientes S.A de C.V
- Investigacion En Salud Y Metabolismo S.C.
- Sociedad de Metabolismo y Corazon S.C
- Noordwest Ziekenhuisgroep
- Ziekenhuisgroep Twente, Almelo
- Meander Medisch Centrum
- Ziekenhuis Amstelland
- BovenlJ Ziekenhuis
- Amsterdam UMC, Locatie AMC
- Gelre ziekenhuizen, locatie Lukas
- Rijnstate
- Haga Ziekenhuis
- Deventer Ziekenhuis
- Albert Schweitzer Ziekenhuis, Dordwijk
- Gelderse Vallei Ziekenhuis, Ede
- Catharina Ziekenhuis Eindhoven
- Spaarne Gasthuis, Hoofddorp
- Zuyderland Medisch Centrum - Heerlen
- Huisartsenpraktijk Gorecht
- Quality Care Research
- Leids Universitair Medisch Centrum
- Bravis Ziekenhuis, Roosendaal
- Maasstad Ziekenhuis, Zuider
- Ikazia Ziekenhuis
- Albert Schweitzer Ziekenhuis, Zwijndrecht
- Bernhoven Uden
- UMC Utrecht
- Diakonessenhuis, Utrecht
- Maxima Medisch Centrum
- VieCuri Medisch Centrum
- NZOZ Centrum Medyczne KERmed
- KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp
- Poradnia Kardiologiczna Jarosław Jurowiecki
- Synexus Polska SCM Sp. z o.o. Gdansku
- Uniwersyteckie Centrum Kliniczne
- Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek. med. Krzysztof Cymerman
- Synexus Polska Sp. z o.o. Oddzial w Gdyni
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
- Synexus Polska Sp. z o.o. Oddzial w Katowicach
- Centrum Medyczne Pratia Katowice II
- SPSK Nr 7 SUM w Katowicach Gornoslaskie CM im. prof. Leszka Gieca
- Specjalistyczna Poradnia Kardiologiczna i Nadciśnienia Tętniczego
- Augustyn Monika
- Krakowskie Centrum Medyczne Sp. z o.o.
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
- NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
- Indywidualna Specjalistyczna Praktyka Lekarska
- KO-MED Centra Kliniczne Lublin II
- Clinical Best Solutions
- NZOZ Twoja Przychodnia
- NZOZ Osrodek Kardiologii Inwazyjnej -Ikardia
- Medicome Sp. z o.o.
- Synexus Polska sp. z o.o. Oddzial w Poznaniu
- Praktyka Lekarska Ewa Krzyzagorska
- KO-MED Centra Kliniczne Pulawy
- NZOZ Przychodnia Specjalistyczna H. Rudzki, A. Wittek
- Centrum Medyczne Medyk
- Clinmed Research
- NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
- NSZOZ Medicus
- KO-MED Centra Kliniczne Staszow
- Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Agnieszka Karczmarczyk Specjalista Chorob
- NBR Polska
- Centrum Medyczne Świat Pacjenta
- Synexus Polska Sp. z o.o. Oddział w Warszawie
- Centrum Zdrowia Tuchow Sp. z o.o.
- Synexus Polska Sp. z o.o. Oddział we Wroclawiu
- KO-MED Centra Kliniczne Zamosc
- VA Medical Center - San Juan
- S.C. CMI Dr. Pletea Noemi S.R.L
- Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
- S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
- Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu"
- S.C Clinica Medicala Data Plus S.R.L
- Spitalul Clinic Colentina
- Spitalul Clinic de Urgenta "Sfantul Pantelimon"
- S.C. Health Net S.R.L
- S.C Policlinica CCBR S.R.L
- CMI Dr. Stolea T. Violeta - Medic specialist diabet zaharat, nutritie si boli metabolice
- S.C. Medcon S.R.L.
- S.C Grandmed S.R.L
- S.C Pelican Impex S.R.L
- S.C. Bella Praxis S.R.L
- S.C. Diabmed Dr. Popescu Alexandrina S.R.L
- CMI Dr Busegeanu Mihaela Magdalena
- S.C Mediab S.R.L
- S.C Medicali's S.R.L
- Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
- SBIH of Arkhangelsk region " First City Clinical hospital n.a. E. E. Volosevich"
- TSHI "Altay Territorial Cardiologocal dispensary"
- SEIHPE "Ural SMA of RosZdrav" b.o. LLC "City Hospital #41"
- FSHI "MSU of MoIA of RF of Kemerovo Region"
- FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"
- NSIH "Departmental Hospital on Station Kemerovo of OJSC "Russian Railways"
- SAIH "Kemerovo Regional Clinical Hospital"
- TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
- SBIH of Moscow "City Clinical Hospital n.a.Bakhrushinykh"
- SBHI "City Polyclinic #2 of Healthcare department of city of Moscow"
- FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
- FSBI "Central Clinical Hospital with Polyclinic of the Department for Presidential Affairs of the RF
- SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov" of the MoH of the RF
- SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov" of the MoH of the RF
- Murmansk Regional Clinical Hospital named after Bayandin
- SBIH of Novosibirsk Region "Clinical Emergency Hospital #2"
- SBIH of Novosibirsk region "City Clinical Hospital # 19"
- FSBSI "Scientific Research Institute of Therapy and Preventive Medicine"
- LLC "RC Medical"
- BIH of Omsk region "Clinical Medico-Sanitary Unit # 9
- Llc Ultramed
- SBIH of Perm territory " City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral"
- State Budgetary Healthcare Institution Clinical Medical Sani
- SHI "Perm Regional Hospital of War Veterans"
- City Emergency Hospital #2
- CJSC Clinic complex
- FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF
- Saint-Petersburg SBHI "City outpatient clinic #28"
- Pavlov First Saint Petersburg State Medical University
- SPb SBIH "City Pokrovskaya Hospital"
- LLC Medical Center Mart
- SIH "Saratov City Clinical Hospital # 2 n.a. V.I. Razumovskiy"
- SPb SBIH "City Hospital # 40 of Kurortnyi region"
- SPb SBIH "City Multy-field Hospital # 2"
- LLC "Institute of Medical Examinations"
- Llc "Medinet"
- SPb SBIH "Nikolaevskaya Hospital"
- FSBI "Research Institute for Cardiology" of Siberian Branch RAMS
- SHI "Regional Clinical Hospital"
- SHI Ulyanovsk Reg Clinical Hospital
- Yaroslavl Regional Clinical Hospital of War Veterans
- Alian s.r.o.
- Thyreomedical s.r.o.
- Metabol KLINIK s.r.o.
- Galenum, s.r.o.
- DIAFA s.r.o.
- Diabet, spol. s.r.o.
- Kardiovaskularne centrum, s.r.o.
- Kardiologicka, interna a sonograficka amb. Kardio-Sanus, sro
- MEDISPEKTRUM PLUS s.r.o.
- MUDr. Vladimir Gergel, s.r.o.
- ENDIAMED, s.r.o.
- MEDICUS plus s.r.o.
- Human-Care s.r.o.
- Sukromna interna a kardiologicka ambulancia
- DIA- Kontrol s.r.o.
- CELL B, s.r.o.
- KARDIO 1 s.r.o.
- IN-DIA s.r.o.
- MUDr. Zuzana Ochodnicka,
- Fakultna nemocnica s poliklinikou Nove Zamky
- DIABETOL s.r.o.
- Medispol s.r.o.
- Nemocnica s poliklinikou sv. Barbory Roznava a.s.
- Peter Farkas MD, s.r.o.
- Interna SK s.r.o.
- Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
- Diabetes centrum, s.r.o.
- JAL s.r.o.
- MEDIVASA s.r.o.
- Cardiology Clinical Research
- Johese Clinical Research: Unitas
- Medicross Roodepoort Clinical Research
- Lenasia Clinical Trial Centre
- Wits Clinical Research
- Clinresco Centres (Pty) Ltd
- Synexus SA - Stanza Clinical Research Centre
- Seeber, M
- Emmed Research
- Synexus SA Watermeyer Clinical Research Centre
- Johese Clinical Research: Midstream
- Limpopo Clinical Research Initiative
- Dr AA Mahomed Medical Centre
- Synexus Helderberg Clinical Research Centre
- Corbod Research
- Tread Research
- Tiervlei Trial Centre
- Cape Town Medical Research Centre
- Paarl Research Centre
- Groote Schuur Hospital Lipid Laboratory
- Dr JM Engelbrecht Practice
- Helderberg Research Institute
- Hospital Universitari Germans Trias i Pujol
- Hospital Virgen del Camino
- Hospital Universitario Reina Sofia
- Complejo Hospitalario Universitario A Coruña
- Complejo Hospitalario Universitario de Santiago
- Hospital Virgen del Mar
- Hospital del Mar
- Hospital Quironsalud Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital Universitario Ramon y Cajal
- Hospital Regional Universitario de Malaga
- Nuevas tecnologías en Diabetes y Endocrinología
- Hospital Quironsalud Infanta Luisa
- Hospital Universitario Virgen Macarena
- Cherkasy Regional Cardiological Center
- CI Cherkasy RH of Cherkasy Regional Council
- CMI CCH#3 Dep of Ther# w the beds of card profile HSEI of UBSMU
- RCI Chernivtsi Regional Endocrinology Center Policlinic Dept SHEI of UBSMU
- CI Dnipropetrovsk City Cl Hosp #9 of Dniprop Reg Council SI DMA of MOH of Ukr Ch of Endocrinology
- Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
- Regional CH Dept of Endocrinology SHEI Ivano-Frankivsk NMU
- CI Ivano-Frankivsk Reg Cl Card Center Dept of Chronic Ischemic Heart Dis SHEI Ivano-Frank NMU
- Ivano-Frankivsk CCH Dept of Therapy #1 SHEI Ivano-Frankivsk NMU
- CHI Kharkiv City Student Hosp Therap dept Nat Pharm Univer
- CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 KCC
- GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
- State Institution LT Malaya Inst. of Ther. of AMS of Ukraine
- Railway Transport Kharkiv CH #1 of Healthcare Center Branch of PJSC Ukr Railway
- Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway
- MC Doctor Alex Dept of General Practice-Family Medicine Kharkiv MA of PGE
- CNE City Clin Hosp #8 of KCC Dept of Therapy Kharkiv MA of PGE of MOHU
- CI Ye.Ye.Karabelesh Kherson City Clinical Hosp.
- KCCC of Endocr Dept of General Endocrine Pathology O. O. Bogomolets NMU
- Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
- LLC Treatment and Diagnostic Center Adonis Plus
- MC of PHEI Institute of General Practice - Family Medicine
- Medical Center Blagomed Plus LLC
- Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
- MC of Subsidiary Production Unit Med Scient Pract Union Medbud of PJSc Holding Company Kyivmiskbud
- Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway
- Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
- SI National Scientific Centre of Radiation Medicine of NAMSU
- SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU
- SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
- Department of Medical Services and Rehabilitation of State Joint Stock Holding Company Artem
- Medical Center of Limited Liability Company Medical Center Concilium Medical
- CI of Kyiv RC Regional Clinical Hospital #2
- SI V.P.Komisarenko Institute of E&M of NAMSU
- SI V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMSU
- Lviv Reg St Clin Treatment - Diagnostic Endocrin Center, Dept of Polyclinic, D.Galytskyy Lviv NMU
- Lviv Communal 4th City Clinical Hospital
- Center of Reconstructive & Restorative Medicine (University Clinic) of Odessa National Medical Uni
- CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
- Ternopil City Municipal Hospital #2 Dept of Gastroenterology Ternopil I.Ya. Gorbachevskyi SMU
- Transcarpathian Regional Clinical Cardiology Dispansery
- Private Small Enterprise Medical Center Pulse
- Vinnytsia RC Highly Special.Endocr.Center Dept of Therapy #2 M.I. Pyrogov NMU
- National Pirogov Memorial Medical University
- SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
- CI Zapor CCH#10 SI ZMA PGE Ch of therapy clin pharmacol & endocrin
- CI Central City Hospital #1 of Zhytomyr
- Zhytomyr regional clinical hospital n.a. O.F. Gerbachevskyy
- Synexus Thames
- Mounts Bay Medical Ltd
- Oak Tree Surgery
- The Alverton Practice
- Rame Medical Limited
- Knowle House Surgery
- Torbay Hospital
- Synexus Clinical Research North Tees
- Broomfield Hospital
- Barts Hospital
- Manchester Royal Infirmary
- Synexus Manchester Clinical Research Centre
- Waterloo Medical Centre
- Synexus Lancashire Clinical Research Centre
- Synexus Merseyside Clinical Research Centre
- Synexus Hexham General Hospital
- Synexus Wales Clinical Research Centre
- Synexus Scotland Clinical Research Centre
- Ninewells Hospital
- Synexus Birmingham Clinical Research Centre
- Morriston Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment Group
Control Group
K-877 (pemafibrate) tablet twice daily.
Matching K-877 placebo tablet twice daily.