Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

PHASE3CompletedINTERVENTIONAL
Enrollment

551

Participants

Timeline

Start Date

November 28, 2016

Primary Completion Date

June 24, 2019

Study Completion Date

June 24, 2019

Conditions
Severe Hypertriglyceridemia
Interventions
DRUG

K-877

DRUG

Fenofibrate

DRUG

Placebo (for K-877)

DRUG

Placebo (for Fenofibrate)

Trial Locations (220)

12553

Mid-Hudson Medical Research, PLLC - Hopewell Junction, New Windsor

Mid-Hudson Medical Research, PLLC - New Windsor, New Windsor

14075

Lakeshore Primary Care Associate, Hamburg

14127

Orchard Park Family Practice, Orchard Park

15905

Richard M.Kastelic MD and Associates, Johnstown

16602

Clinical Research Associates of Central PA, LLC, Altoona

19438

Harleysville Medical Associates, Harleysville

19446

Green and Seidner Family Practice Associates, Lansdale

20110

Manassas Clinical Research Center, Manassas

21229

Maryland Cardiovascular Specialist, Baltimore

23510

York Clinical Research LLC, Norfolk

26505

Exemplar Research Inc. - Fairmont, WV, Morgantown

28557

Diabetes and Endocrinology Consultants, P.C., Morehead City

29650

DeGarmo Institute Of Medical Research, Greer

30046

Physicians Research Associates, Inc, Lawrenceville

30060

Georgia Institute for Clinical Research, Marietta

31406

Meridian Clinical Research - Savannah, GA, Savannah

31904

Columbus Regional Health, Columbus

32127

Progressive Medical Research, Port Orange

32223

Jacksonville Impotence Treatment Center, Jacksonville

33012

Indago Research and Health Center, Hialeah

33024

ALL Medical Research, LLC, Cooper City

33029

South Florida Research Solutions LLC. - Pembroke Pines, Pembroke Pines

33169

AMPM Research Clinic, Miami Gardens

33306

S & W Clinical Research, Fort Lauderdale

33472

Atlantic Clinical Research Collaborative, Boynton Beach

33634

Meridien Research - Tampa, Tampa

34239

Cardiovascular Center of Sarasota, Sarasota

34474

Ocala Cardiovascular Research, Ocala

34653

Advanced Research Institute Inc, New Port Richey

35205

Central Research Associates, Inc., Birmingham

35209

Central Alabama Research, Birmingham

35242

Cahaba Research, Inc., Birmingham

35570

Boyett Health Services Inc, Hamilton

35674

Terence T. Hart, MD, Tuscumbia

35801

Longwood Research - Saadat Ansari, MD, LLC, Huntsville

37167

Clinical Research Solutions - Smyrna, TN, Smyrna

37620

PMG Research of Bristol, LLC - State, Bristol

37909

New Phase Research & Development - Knoxville, Knoxville

39150

David M. Headley, MD P.A., Port Gibson

40503

The Research Group of Lexington, LLC, Lexington

42303

Research Integrity LLC, Owensboro

43213

Aventiv Research, Inc., Columbus

43302

Rama Research LLC, Marion

RAS Health Ltd, Marion

44094

Ohio Clinical Research, LLC - Willoughby Hills, Willoughby Hills

44124

Ohio Clinical Research - Lyndhurst, Lyndhurst

44262

Summit Research Group, LLC, Munroe Falls

45005

Prestige Clinical Research, Franklin

45219

Sterling Research Group, Ltd. - Auburn, Cincinnati

45417

Alpha Research Associates, LLC, Dayton

46011

Community Hospital of Anderson and Madison County, Inc, Anderson

46103

American Health Network - Avon Clinical Research Department, Avon

46260

Midwest Institute for Clinical Research, Indianapolis

46383

Buynak Clinical Research, P.C., Valparaiso

47714

Medisphere Medical Research Center, Evansville

48085

Oakland Medical Research Center, Troy

48504

Aa Mrc, Llc, Flint

50266

The Iowa Clinic - Cardiovascular Services, West Des Moines

51501

West Broadway Clinic, Council Bluffs

53226

Allegiance Research Specialists, LLC, Wauwatosa

57702

Health Concepts, Rapid City

58104

Lillestol Research, LLC, Fargo

59901

Glacier View Research Institute, Kalispell

60160

Lemah Creek Clinical Research, Melrose Park

60616

Apex Medical Research - Illinois, Chicago

61550

Koch Family Medicine, Morton

63122

Consult and Research Associates, St Louis

63128

Advance Clinical Research, Inc, St Louis

70006

Clinical Trials Management LLC - Southshore, Metairie

70443

Clinical Trials Management, LLC - Northshore, Covington

71291

Clinical Trials of America, LLC - West Monroe, LA, West Monroe

72205

iResearch - Little Rock, Little Rock

Lynn Institute of the Ozarks, Little Rock

73135

South Oklahoma Heart Research, Oklahoma City

75208

Protenium Clinical Research, LLC - Dallas, Dallas

75216

VA North Texas Health Care System - Dallas VA Medical Center (DVAMC), Dallas

76014

Health Innovation Research Group, Arlington

76054

Protenium Clinical Research, LLC, Hurst

76550

FMC Science, Lampasas

77040

Juno Research, LLC - Northwest Site, Houston

77058

Centex Studies, Inc., Houston

77074

Juno Research, LLC - Southwest Houston Site, Houston

77099

Pioneer Research Solutions Inc., Houston

77340

Grace Research, LLC - Huntsville, TX, Huntsville

77450

Juno Research, LLC - Katy, Katy

77521

Inquest Clinical Research, Baytown

78220

San Antonio Premier Internal Medicine, San Antonio

78228

Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute, San Antonio

78229

Pinnacle Clinical Research, San Antonio

78249

Bandera Family HealthCare Research, LLC (BFHC), San Antonio

78503

DCT - McAllen Primary Care, LLC, McAllen

78758

DCT-AACT, LLC, dba Discovery Clinical Trials, Austin

79935

Academy of Diabetes, Thyroid and Endocrine, P.A., El Paso

80246

Creekside Endocrine Associates, PC, Denver

83646

Solaris Clinical Research, Meridian

85018

Elite Clinical Studies, Phoenix

85306

Arrowhead Health Centers, Glendale

85374

Clinical Research Institute of Arizona, LLC, Surprise

85381

Phoenix Medical Research Institute, LLC, Peoria

87108

Lovelace Scientific Resources, Albuquerque

89052

Desert Endocrinology Clinical Research Center - Henderson, Henderson

89148

Palm Research Center, Inc., Las Vegas

90017

Downtown L.A. Research Center, Inc., Los Angeles

90650

Lucita M. Cruz, MD., Inc., Norwalk

90717

Torrance Clinical Research Institute Inc., Lomita

91763

Catalina Research Institute, LLC, Montclair

92805

Advanced Research Center, Anaheim

67205-1138

Professional Research Network of Kansas, LLC, Wichita

02908

Center for Medical Research, LLC, Providence

Unknown

Brest Regional Hospital, Brest

Grodno University Hospital, Grodno

Gomel Regional Clinical Center of Cardiology, Homyel

Gomel Regional Clinical Hospital, Homyel

City Clinical Hospital #10, Minsk

City Clinical Hospital #1, Minsk

Minsk Regional Clinical Hospital, Minsk

Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology, Minsk

Mogilev Regional Medical and Diagnostic Center, Mogilev

Vitebsk Regional Clinical Hospital, Vitebsk

Medical Center Diamedical 2013 OOD, Dimitrovgrad

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic, Pleven

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic, Pleven

UMHAT Sveti Georgi - Clinic of Cardiology, Plovdiv

MHAT Dr. Bratan Shukjerov, Smolyan

Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD, Smolyan

Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology, Sofia

Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases, Sofia

Medical Center Orfey OOD, Stara Zagora

Lipidova poradna, Bílina

Medicus Services SRO, Brandýs nad Labem

Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka, Hradec Králové

Onkologicka klinika 2. LF UK a FN Motol, Prague

Ordinace pro choroby srdce a cev, Prague

Vseobecna fakultni nemocnice v Praze, Prague

Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie, Trutnov

MUDr. Nina Zemkova s.r.o. Interni Ambulance, Uherské Hradište

Unimed Ajara LLC, Batumi

Clinic LJ Ltd, Kutaisi

Aleksandre Aladashvili Clinic - LLC, Tbilisi

Archangel St Michael Multiprofile Clinical Hospital Ltd, Tbilisi

Emergency Cardiology Center by Academician G. Chapidze Ltd, Tbilisi

Institute of Clinical Cardiology Ltd, Tbilisi

Unimed Kakheti - Caraps Medline LLC, Tbilisi

Unimed Kakheti - Telavi Referral Hospital LLC, Telavi

DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred

DRC Balatongyorok, Balatongyörök

Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo, Békéscsaba

Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly, Budapest

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

Debreceni Egyetem Klinikai Kozpont, Debrecen

BKS Research Kft., Hatvan

Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika, Pécs

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman, Gdynia

SALVIA Lekston i Madej s.j., Katowice

Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O, Krakow

AppleTreeClinics Sp. z o.o., Lodz

NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek, Lodz

Nzoz Salusmed, Lodz

MEDICOME Sp. z o.o., Oświęcim

Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznan

Praktyka Lekarska Ewa Krzyzagorska, Poznan

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O, Płock

Clinmedica Research Omc Sp z o.o. Sp, Skierniewice

Centrum Kardiologiczne Pro Corde Sp. z o. o., Wroclaw

City Clinical Hospital n.a. M.P. Konchalovskiy, Zelenograd

First City Clinical Hospital n.a. E.E.Volosevich, Arkhangelsk

Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency, Arkhangelsk

Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction, Barnaul

Chita State Medical Academy, Chita

Interregional Clinical Diagnostic Center, Kazan'

Kazan State Medical University based at City Clinical Hospital #7, Kazan'

"Federal State Budget Institution Scientific-Research Institute of Complex Problems of Cardiovascular Diseases", Kemerovo

"Medical Center Alliance", Kirovsk

Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky, Krasnoyarsk

Central Clinical Hospital of Russian Academy of Sciences, Moscow

City Clinical Hospital #15 n.a. O.M. Filatov, Moscow

City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department, Moscow

"Federal State Budget Institution Outpatient Clinic #3 of Russian Federation President's Management Department", Moscow

National Medical Research Center of Cardiology - Department of Atherosclerosis, Moscow

National Medical Research Center of Cardiology, Moscow

National Medical Research Center of Preventive Medicine, Moscow

"Non-governmental Private Healthcare Institution Scientific Clinical Centre of Open Joint-Stock Company Russian Railways (JSC RZD)", Moscow

City Clinical Hospital No.2, Novosibirsk

RC Medical LLC, Novosibirsk

Research Institute of Physiology and Fundamental Medicine, Novosibirsk

Orenburg State Medical University based at City Clinical Hospital #1, Orenburg

"Clinical-diagnostic center Zdorovye", Rostov-on-Don

Rostov-on-Don City Hospital of Emergency Care, Rostov-on-Don

Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology, Saint Petersburg

Almazov National Medical Research Centre, Saint Petersburg

BioTechService LLC, Saint Petersburg

City hospital #38 n.a. N.A. Semashko, Saint Petersburg

Clinic Complex JSC, Saint Petersburg

Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency, Saint Petersburg

Consultative Diagnostic Center with Out-patient Clinic, Saint Petersburg

"Limited Liability Company MedPomosch", Saint Petersburg

Medical Technologies LLC, Saint Petersburg

North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg

"Saint-Petersburg State Budget Healthcare Institution City Pokrovskaya Hospital, Cardiology Departmen", Saint Petersburg

Regional Clinical Cardiology Dispensary, Saratov

Saratov State Medical University n. a. V.I. Razumovsky, Saratov

Tomsk National Research Medical Center of Russian Academy of Sciences, Tomsk

"Autonomous Institution of healthcare of the Voronezh region Voronezh regional clinical consultative and diagnostic centre", Voronezh

"Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly Zdorovoe Dolgoletie", Yaroslavl

Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District, Yekaterinburg

Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department, Ivano-Frankivsk

"JSC Ukrainian Railways Kharkiv Railway Clinical Hospital#1 of Branch Healthcare Center of PJSC Ukrainian Railways, Cardiology Depart #1", Kharkiv

"JSC Ukrainian Railways Kharkiv Railway Clinical Hospital#1 of Branch Healthcare Center of PJSC Ukrainian Railways, Cardiology Depart #2", Kharkiv

"Municipal Non-Commercial Enterprise City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov of Kharkiv City Council", Kharkiv

"Municipal Noncommercial Enterprise City Clinical Hospital #27 of Kharkiv City Council", Kharkiv

"Municipal Noncommercial Enterprise City Outpatient Clinic #9 of Kharkiv City Council", Kharkiv

Kyiv City Clinical Hospital #1, Urgent Cardiology Department, Kyiv

"Limited Liability Company Treatment and Diagnostic Center Adonis Plus, Outpatient Department", Kyiv

"SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t., Gen. Ther.Unit", Kyiv

"SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t", Kyiv

"Municipal Institution City Clinical Hospital #3 n.a. prof. L.J. Aleinikova, Cardiology Intensive Therapy Department", Odesa

"Small Private Enterprise, Medical Centre Puls", Vinnytsia

"Municipal Institution City Clinical Hospital #6, Therapeutic Department", Zaporizhzhia

Sponsors
All Listed Sponsors
lead

Kowa Research Institute, Inc.

INDUSTRY