Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

PHASE3CompletedINTERVENTIONAL
Enrollment

471

Participants

Timeline

Start Date

November 26, 2016

Primary Completion Date

July 5, 2019

Study Completion Date

July 5, 2019

Conditions
Severe Hypertriglyceridemia
Interventions
DRUG

K-877

DRUG

Fenofibrate

DRUG

Placebo (for K-877)

Trial Locations (241)

102

Aleksandre Aladashvili Clinic - LLC, Tbilisi

159

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

1062

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

1134

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1233

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

2002

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

2091

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

2200

Unimed Kakheti - Telavi Referral Hospital LLC, Telavi

2760

Regeneris Medical, North Attleboro

2908

Center for Medical Research, LLC, Providence

3000

BKS Research Kft., Hatvan

4002

University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - Clinic of Cardiology, Plovdiv

4114

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

4600

Clinic LJ Ltd, Kutaisi

4700

MHAT Dr. Bratan Shukjerov, Smolyan

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

5600

Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo, Békéscsaba

5800

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

6000

Medical Center Orfey OOD, Stara Zagora

6010

Unimed Ajara LLC, Batumi

6400

Medical Center Diamedical 2013 OOD, Dimitrovgrad

7624

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

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

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

15006

Fakultni nemocnice v Motole, Prague

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

21001

Small Private Enterprise, Medical Centre Puls, Vinnytsia

21229

Maryland Cardiovascular Specialists, Baltimore

23454

Cardiovascular Associates, Ltd, Virginia Beach

23501

York Clinical Research LLC, Norfolk

26505

Exemplar Research Inc. - Fairmont, WV, Morgantown

28557

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

29588

Family Medicine of SayeBrook, Myrtle Beach

29625

MD First Research, Anderson

MDFirst Research - Anderson, Anderson

29650

DeGarmo Institute Of Medical Research, Greer

29720

MD First Research, Lancaster

30030

iResearch, Decatur

30046

Physicians Research Associates, Inc, Lawrenceville

30060

Georgia Institute for Clinical Research, Marietta

30076

Endocrine Research Solutions, Inc, Roswell

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

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

Meridien Research, 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

37404

Chattanooga Research & Medicine, PLLC, Chattanooga

37620

PMG Research of Bristol, LLC - State, Bristol

37660

Holston Medical Group, Kingsport

37909

New Phase Research & Development, Knoxville

39150

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

40503

Kentucky Diabetes Endocrinology Center, Lexington

The Research Group of Lexington, LLC, Lexington

41801

Lipidova poradna, Bílina

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

44626

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

58103

Lillestol Research, LLC, Fargo

59901

Glacier View Research Institute, Kalispell

60527

Lemah Creek Clinical Research, Burr Ridge

60607

Cedar-Crosse Research Center, Chicago

60616

Apex Medical Research, Chicago

61002

Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department, Kharkiv

61103

Kharkiv Medical Academy of Postgraduate Education, Kharkiv

"Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #2", Kharkiv

Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1, Kharkiv

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

61172

Municipal Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1, Kharkiv

61550

Koch Family Medicine, Morton

63122

Consult and Research Associates, St Louis

63128

Advance Clinical Research, Inc, St Louis

65014

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

67205

Professional Research Network of Kansas, LLC, Wichita

68601

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

69035

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

70006

Clinical Trials Management LLC - Southshore, Metairie

70443

Clinical Trials Management, LLC - Northshore, Covington

71105

Grace Research, LLC, Shreveport

71291

Clinical Trials of America, LLC, West Monroe

72205

iResearch, Little Rock

Lynn Institute of the Ozarks, Little Rock

73107

COR Clinical Research, LLC., Oklahoma City

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

76018

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

76054

Protenium Clinical Research, LLC, Hurst

76550

FMC Science, Lampasas

77040

Juno Research, LLC, Houston

77058

Centex Studies, Inc., Houston

77074

Juno Research, LLC, Houston

77099

Pioneer Research Solutions Inc., Houston

77340

Grace Research, LLC, Huntsville

77450

Juno Research, LLC, 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

78233

Pinnacle Clinical Research, Live Oak

78249

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

78404

Padre Coast Clinical Research, Corpus Christi

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

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

92117

Integrated Research Center, San Diego

92663

Pacific Coast Cardiology and Research, Newport Beach

92805

Advanced Research Center, Anaheim

94102

Optimus Medical Group, San Francisco

101990

National Medical Research Center of Preventive Medicine, Moscow

111539

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

117593

Central Clinical Hospital of Russian Academy of Sciences, Moscow

121374

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

121552

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

National Medical Research Center of Cardiology, Moscow

124489

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

125315

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

129090

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

150047

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

163000

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

163001

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

187342

Medical Center Alliance, Kirovsk

190013

Clinic Complex JSC, Saint Petersburg

191015

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

191025

Medical Technologies LLC, Saint Petersburg

194156

Almazov National Medical Research Centre, Saint Petersburg

194291

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

194356

Limited Liability Company MedPomosch, Saint Petersburg

196601

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

197022

BioTechService LLC, Saint Petersburg

197110

Consultative Diagnostic Center with Out-patient Clinic, Saint Petersburg

197341

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

199106

"Saint-Petersburg State Budget Healthcare Institution City Pokrovskaya Hospital, Department of Cardiology N.3", Saint Petersburg

210037

Vitebsk Regional Clinical Hospital, Vitebsk

212030

Mogilev Regional Medical and Diagnostic Center, Mogilev

220013

City Clinical Hospital #1, Minsk

220045

City Clinical Hospital #9, Minsk

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

220096

City Clinical Hospital #10, Minsk

223041

Minsk Regional Clinical Hospital, Minsk

224027

Brest Regional Hospital, Brest

230030

Grodno University Hospital, Grodno

246029

Gomel Regional Clinical Hospital, Homyel

246046

Gomel Regional Clinical Center of Cardiology, Homyel

344011

Clinical-diagnostic center Zdorovye, Rostov-on-Don

344068

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

394018

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

410028

Regional Clinical Cardiology Dispensary, Saratov

410054

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

420101

Interregional Clinical Diagnostic Center, Kazan'

420103

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

460000

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

620028

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

630051

City Clinical Hospital No.2, Novosibirsk

630091

RC Medical LLC, Novosibirsk

630117

Research Institute of Physiology and Fundamental Medicine, Novosibirsk

634012

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

650002

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

656055

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

660062

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

672000

Chita State Medical Academy, Chita

250 01

Medicus Services SRO, Brandýs nad Labem

500 05

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

101 00

Ordinace pro choroby srdce a cev, Prague

128 08

Vseobecna fakultni nemocnice v Praze, Prague

541 21

Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie, Trutnov

H-8230

DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred

H-8313

DRC Balatongyorok, Balatongyörök

H-4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

81-157

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

40-772

SALVIA Lekston i Madej s.j., Katowice

31-534

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

90-349

AppleTreeClinics Sp. z o.o., Lodz

91 302

Nzoz Salusmed, Lodz

94-048

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

32-600

MEDICOME Sp. z o.o., Oświęcim

60-589

Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznan

61-655

Praktyka Lekarska Ewa Krzyzagorska, Poznan

09-400

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

96-100

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

50-315

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

Sponsors
All Listed Sponsors
lead

Kowa Research Institute, Inc.

INDUSTRY