Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
NCT ID: NCT03001817
Last Updated: 2022-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
551 participants
INTERVENTIONAL
2016-11-28
2019-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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12 Week Efficacy
K-877 or placebo comparator twice daily for 12 weeks
K-877
Placebo (for K-877)
40 Week Extension
K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks
K-877
Fenofibrate
Placebo (for K-877)
Placebo (for Fenofibrate)
Interventions
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K-877
Fenofibrate
Placebo (for K-877)
Placebo (for Fenofibrate)
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years;
3. Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):
1. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA) presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
2. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
3. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
4. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;
4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria:
Exclusion Criteria
2. Body mass index (BMI) \>45 kg/m2 at Visit 1 (Week -8 or Week -6);
3. Patients with type 1 diabetes mellitus;
4. Patients with newly diagnosed (within 3 months prior to Visit 2 \[Week -2\]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c \>9.5% at Visit 1 (Week -8 or Week -6);
18 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Central Research Associates, Inc.
Birmingham, Alabama, United States
Central Alabama Research
Birmingham, Alabama, United States
Cahaba Research, Inc.
Birmingham, Alabama, United States
Boyett Health Services Inc
Hamilton, Alabama, United States
Longwood Research - Saadat Ansari, MD, LLC
Huntsville, Alabama, United States
Terence T. Hart, MD
Tuscumbia, Alabama, United States
Arrowhead Health Centers
Glendale, Arizona, United States
Phoenix Medical Research Institute, LLC
Peoria, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, United States
iResearch - Little Rock
Little Rock, Arkansas, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Advanced Research Center
Anaheim, California, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Lucita M. Cruz, MD., Inc.
Norwalk, California, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
Atlantic Clinical Research Collaborative
Boynton Beach, Florida, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
S & W Clinical Research
Fort Lauderdale, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States
AMPM Research Clinic
Miami Gardens, Florida, United States
Advanced Research Institute Inc
New Port Richey, Florida, United States
Ocala Cardiovascular Research
Ocala, Florida, United States
South Florida Research Solutions LLC. - Pembroke Pines
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Meridien Research - Tampa
Tampa, Florida, United States
Columbus Regional Health
Columbus, Georgia, United States
Physicians Research Associates, Inc
Lawrenceville, Georgia, United States
Georgia Institute for Clinical Research
Marietta, Georgia, United States
Meridian Clinical Research - Savannah, GA
Savannah, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Apex Medical Research - Illinois
Chicago, Illinois, United States
Lemah Creek Clinical Research
Melrose Park, Illinois, United States
Koch Family Medicine
Morton, Illinois, United States
Community Hospital of Anderson and Madison County, Inc
Anderson, Indiana, United States
American Health Network - Avon Clinical Research Department
Avon, Indiana, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
The Iowa Clinic - Cardiovascular Services
West Des Moines, Iowa, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, United States
Research Integrity LLC
Owensboro, Kentucky, United States
Clinical Trials Management, LLC - Northshore
Covington, Louisiana, United States
Clinical Trials Management LLC - Southshore
Metairie, Louisiana, United States
Clinical Trials of America, LLC - West Monroe, LA
West Monroe, Louisiana, United States
Maryland Cardiovascular Specialist
Baltimore, Maryland, United States
Aa Mrc, Llc
Flint, Michigan, United States
Oakland Medical Research Center
Troy, Michigan, United States
David M. Headley, MD P.A.
Port Gibson, Mississippi, United States
Consult and Research Associates
St Louis, Missouri, United States
Advance Clinical Research, Inc
St Louis, Missouri, United States
Glacier View Research Institute
Kalispell, Montana, United States
Desert Endocrinology Clinical Research Center - Henderson
Henderson, Nevada, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, United States
Lakeshore Primary Care Associate
Hamburg, New York, United States
Mid-Hudson Medical Research, PLLC - Hopewell Junction
New Windsor, New York, United States
Mid-Hudson Medical Research, PLLC - New Windsor
New Windsor, New York, United States
Orchard Park Family Practice
Orchard Park, New York, United States
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Alpha Research Associates, LLC
Dayton, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Ohio Clinical Research - Lyndhurst
Lyndhurst, Ohio, United States
Rama Research LLC
Marion, Ohio, United States
RAS Health Ltd
Marion, Ohio, United States
Summit Research Group, LLC
Munroe Falls, Ohio, United States
Ohio Clinical Research, LLC - Willoughby Hills
Willoughby Hills, Ohio, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Clinical Research Associates of Central PA, LLC
Altoona, Pennsylvania, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Richard M.Kastelic MD and Associates
Johnstown, Pennsylvania, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, United States
Center for Medical Research, LLC
Providence, Rhode Island, United States
DeGarmo Institute Of Medical Research
Greer, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
PMG Research of Bristol, LLC - State
Bristol, Tennessee, United States
New Phase Research & Development - Knoxville
Knoxville, Tennessee, United States
Clinical Research Solutions - Smyrna, TN
Smyrna, Tennessee, United States
Health Innovation Research Group
Arlington, Texas, United States
DCT-AACT, LLC, dba Discovery Clinical Trials
Austin, Texas, United States
Inquest Clinical Research
Baytown, Texas, United States
Protenium Clinical Research, LLC - Dallas
Dallas, Texas, United States
VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)
Dallas, Texas, United States
Academy of Diabetes, Thyroid and Endocrine, P.A.
El Paso, Texas, United States
Juno Research, LLC - Northwest Site
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Juno Research, LLC - Southwest Houston Site
Houston, Texas, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
Grace Research, LLC - Huntsville, TX
Huntsville, Texas, United States
Protenium Clinical Research, LLC
Hurst, Texas, United States
Juno Research, LLC - Katy
Katy, Texas, United States
FMC Science
Lampasas, Texas, United States
DCT - McAllen Primary Care, LLC
McAllen, Texas, United States
San Antonio Premier Internal Medicine
San Antonio, Texas, United States
Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
San Antonio, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
York Clinical Research LLC
Norfolk, Virginia, United States
Exemplar Research Inc. - Fairmont, WV
Morgantown, West Virginia, United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, United States
Brest Regional Hospital
Brest, , Belarus
Grodno University Hospital
Grodno, , Belarus
Gomel Regional Clinical Center of Cardiology
Homyel, , Belarus
Gomel Regional Clinical Hospital
Homyel, , Belarus
City Clinical Hospital #10
Minsk, , Belarus
City Clinical Hospital #1
Minsk, , Belarus
Minsk Regional Clinical Hospital
Minsk, , Belarus
Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
Minsk, , Belarus
Mogilev Regional Medical and Diagnostic Center
Mogilev, , Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
Medical Center Diamedical 2013 OOD
Dimitrovgrad, , Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic
Pleven, , Bulgaria
UMHAT Sveti Georgi - Clinic of Cardiology
Plovdiv, , Bulgaria
MHAT Dr. Bratan Shukjerov
Smolyan, , Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, , Bulgaria
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology
Sofia, , Bulgaria
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases
Sofia, , Bulgaria
Medical Center Orfey OOD
Stara Zagora, , Bulgaria
Lipidova poradna
Bílina, , Czechia
Medicus Services SRO
Brandýs nad Labem, , Czechia
Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka
Hradec Králové, , Czechia
Onkologicka klinika 2. LF UK a FN Motol
Prague, , Czechia
Ordinace pro choroby srdce a cev
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie
Trutnov, , Czechia
MUDr. Nina Zemkova s.r.o. Interni Ambulance
Uherské Hradište, , Czechia
Unimed Ajara LLC
Batumi, , Georgia
Clinic LJ Ltd
Kutaisi, , Georgia
Aleksandre Aladashvili Clinic - LLC
Tbilisi, , Georgia
Archangel St Michael Multiprofile Clinical Hospital Ltd
Tbilisi, , Georgia
Emergency Cardiology Center by Academician G. Chapidze Ltd
Tbilisi, , Georgia
Institute of Clinical Cardiology Ltd
Tbilisi, , Georgia
Unimed Kakheti - Caraps Medline LLC
Tbilisi, , Georgia
Unimed Kakheti - Telavi Referral Hospital LLC
Telavi, , Georgia
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
DRC Balatongyorok
Balatongyörök, , Hungary
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
Békéscsaba, , Hungary
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
BKS Research Kft.
Hatvan, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
Pécs, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
Gdynia, , Poland
SALVIA Lekston i Madej s.j.
Katowice, , Poland
Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O
Krakow, , Poland
AppleTreeClinics Sp. z o.o.
Lodz, , Poland
NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
Lodz, , Poland
Nzoz Salusmed
Lodz, , Poland
MEDICOME Sp. z o.o.
Oświęcim, , Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, , Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
Płock, , Poland
Clinmedica Research Omc Sp z o.o. Sp
Skierniewice, , Poland
Centrum Kardiologiczne Pro Corde Sp. z o. o.
Wroclaw, , Poland
City Clinical Hospital n.a. M.P. Konchalovskiy
Zelenograd, Moscow, Russia
First City Clinical Hospital n.a. E.E.Volosevich
Arkhangelsk, , Russia
Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
Arkhangelsk, , Russia
Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction
Barnaul, , Russia
Chita State Medical Academy
Chita, , Russia
Interregional Clinical Diagnostic Center
Kazan', , Russia
Kazan State Medical University based at City Clinical Hospital #7
Kazan', , Russia
Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases"
Kemerovo, , Russia
Medical Center "Alliance"
Kirovsk, , Russia
Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky
Krasnoyarsk, , Russia
Central Clinical Hospital of Russian Academy of Sciences
Moscow, , Russia
City Clinical Hospital #15 n.a. O.M. Filatov
Moscow, , Russia
City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department
Moscow, , Russia
Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
Moscow, , Russia
National Medical Research Center of Cardiology - Department of Atherosclerosis
Moscow, , Russia
National Medical Research Center of Cardiology
Moscow, , Russia
National Medical Research Center of Preventive Medicine
Moscow, , Russia
Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
Moscow, , Russia
City Clinical Hospital No.2
Novosibirsk, , Russia
RC Medical LLC
Novosibirsk, , Russia
Research Institute of Physiology and Fundamental Medicine
Novosibirsk, , Russia
Orenburg State Medical University based at City Clinical Hospital #1
Orenburg, , Russia
Clinical-diagnostic center "Zdorovye"
Rostov-on-Don, , Russia
Rostov-on-Don City Hospital of Emergency Care
Rostov-on-Don, , Russia
Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
Saint Petersburg, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
BioTechService LLC
Saint Petersburg, , Russia
City hospital #38 n.a. N.A. Semashko
Saint Petersburg, , Russia
Clinic Complex JSC
Saint Petersburg, , Russia
Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency
Saint Petersburg, , Russia
Consultative Diagnostic Center with Out-patient Clinic
Saint Petersburg, , Russia
Limited Liability Company "MedPomosch"
Saint Petersburg, , Russia
Medical Technologies LLC
Saint Petersburg, , Russia
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, , Russia
Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen
Saint Petersburg, , Russia
Regional Clinical Cardiology Dispensary
Saratov, , Russia
Saratov State Medical University n. a. V.I. Razumovsky
Saratov, , Russia
Tomsk National Research Medical Center of Russian Academy of Sciences
Tomsk, , Russia
Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre
Voronezh, , Russia
Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"
Yaroslavl, , Russia
Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District
Yekaterinburg, , Russia
Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
Ivano-Frankivsk, , Ukraine
JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1
Kharkiv, , Ukraine
JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2
Kharkiv, , Ukraine
Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council
Kharkiv, , Ukraine
Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council
Kharkiv, , Ukraine
Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
Kharkiv, , Ukraine
Kyiv City Clinical Hospital #1, Urgent Cardiology Department
Kyiv, , Ukraine
Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department
Kyiv, , Ukraine
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, , Ukraine
SI "Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine", Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t
Kyiv, , Ukraine
Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department
Odesa, , Ukraine
Small Private Enterprise, Medical Centre "Puls"
Vinnytsia, , Ukraine
Municipal Institution "City Clinical Hospital #6", Therapeutic Department
Zaporizhzhia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol: ver.1.0
Document Type: Study Protocol: ver.2.0
Document Type: Statistical Analysis Plan: v1.0
Document Type: Statistical Analysis Plan: v2.0
Document Type: Statistical Analysis Plan: Addendum
Other Identifiers
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K-877-301
Identifier Type: -
Identifier Source: org_study_id
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