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

Primary Purpose

Severe Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
K-877
Fenofibrate
Placebo (for K-877)
Placebo (for Fenofibrate)
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
  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:

    1. Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, criterion 3.a. through 3.d.);
    2. Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or
    3. Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high-intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;

Exclusion Criteria:

  1. Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
  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);

Sites / Locations

  • Central Research Associates, Inc.
  • Central Alabama Research
  • Cahaba Research, Inc.
  • Boyett Health Services Inc
  • Longwood Research - Saadat Ansari, MD, LLC
  • Terence T. Hart, MD
  • Arrowhead Health Centers
  • Phoenix Medical Research Institute, LLC
  • Elite Clinical Studies
  • Clinical Research Institute of Arizona, LLC
  • iResearch - Little Rock
  • Lynn Institute of the Ozarks
  • Advanced Research Center
  • Torrance Clinical Research Institute Inc.
  • Downtown L.A. Research Center, Inc.
  • Catalina Research Institute, LLC
  • Lucita M. Cruz, MD., Inc.
  • Creekside Endocrine Associates, PC
  • Atlantic Clinical Research Collaborative
  • ALL Medical Research, LLC
  • S & W Clinical Research
  • Indago Research and Health Center
  • Jacksonville Impotence Treatment Center
  • AMPM Research Clinic
  • Advanced Research Institute Inc
  • Ocala Cardiovascular Research
  • South Florida Research Solutions LLC. - Pembroke Pines
  • Progressive Medical Research
  • Cardiovascular Center of Sarasota
  • Meridien Research - Tampa
  • Columbus Regional Health
  • Physicians Research Associates, Inc
  • Georgia Institute for Clinical Research
  • Meridian Clinical Research - Savannah, GA
  • Solaris Clinical Research
  • Apex Medical Research - Illinois
  • Lemah Creek Clinical Research
  • Koch Family Medicine
  • Community Hospital of Anderson and Madison County, Inc
  • American Health Network - Avon Clinical Research Department
  • Medisphere Medical Research Center
  • Midwest Institute for Clinical Research
  • Buynak Clinical Research, P.C.
  • West Broadway Clinic
  • The Iowa Clinic - Cardiovascular Services
  • Professional Research Network of Kansas, LLC
  • The Research Group of Lexington, LLC
  • Research Integrity LLC
  • Clinical Trials Management, LLC - Northshore
  • Clinical Trials Management LLC - Southshore
  • Clinical Trials of America, LLC - West Monroe, LA
  • Maryland Cardiovascular Specialist
  • Aa Mrc, Llc
  • Oakland Medical Research Center
  • David M. Headley, MD P.A.
  • Consult and Research Associates
  • Advance Clinical Research, Inc
  • Glacier View Research Institute
  • Desert Endocrinology Clinical Research Center - Henderson
  • Palm Research Center, Inc.
  • Lovelace Scientific Resources
  • Lakeshore Primary Care Associate
  • Mid-Hudson Medical Research, PLLC - Hopewell Junction
  • Mid-Hudson Medical Research, PLLC - New Windsor
  • Orchard Park Family Practice
  • Diabetes and Endocrinology Consultants, P.C.
  • Lillestol Research, LLC
  • Sterling Research Group, Ltd. - Auburn
  • Aventiv Research, Inc.
  • Alpha Research Associates, LLC
  • Prestige Clinical Research
  • Ohio Clinical Research - Lyndhurst
  • Rama Research LLC
  • RAS Health Ltd
  • Summit Research Group, LLC
  • Ohio Clinical Research, LLC - Willoughby Hills
  • South Oklahoma Heart Research
  • Clinical Research Associates of Central PA, LLC
  • Harleysville Medical Associates
  • Richard M.Kastelic MD and Associates
  • Green and Seidner Family Practice Associates
  • Center for Medical Research, LLC
  • DeGarmo Institute Of Medical Research
  • Health Concepts
  • PMG Research of Bristol, LLC - State
  • New Phase Research & Development - Knoxville
  • Clinical Research Solutions - Smyrna, TN
  • Health Innovation Research Group
  • DCT-AACT, LLC, dba Discovery Clinical Trials
  • Inquest Clinical Research
  • Protenium Clinical Research, LLC - Dallas
  • VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)
  • Academy of Diabetes, Thyroid and Endocrine, P.A.
  • Juno Research, LLC - Northwest Site
  • Centex Studies, Inc.
  • Juno Research, LLC - Southwest Houston Site
  • Pioneer Research Solutions Inc.
  • Grace Research, LLC - Huntsville, TX
  • Protenium Clinical Research, LLC
  • Juno Research, LLC - Katy
  • FMC Science
  • DCT - McAllen Primary Care, LLC
  • San Antonio Premier Internal Medicine
  • Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
  • Pinnacle Clinical Research
  • Bandera Family HealthCare Research, LLC (BFHC)
  • Manassas Clinical Research Center
  • York Clinical Research LLC
  • Exemplar Research Inc. - Fairmont, WV
  • Allegiance Research Specialists, LLC
  • Brest Regional Hospital
  • Gomel Regional Clinical Center of Cardiology
  • Gomel Regional Clinical Hospital
  • Grodno University Hospital
  • City Clinical Hospital #10
  • City Clinical Hospital #1
  • Minsk Regional Clinical Hospital
  • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
  • Mogilev Regional Medical and Diagnostic Center
  • Vitebsk Regional Clinical Hospital
  • Medical Center Diamedical 2013 OOD
  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic
  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic
  • UMHAT Sveti Georgi - Clinic of Cardiology
  • MHAT Dr. Bratan Shukjerov
  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology
  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases
  • Medical Center Orfey OOD
  • Lipidova poradna
  • Medicus Services SRO
  • Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka
  • Ordinace pro choroby srdce a cev
  • Vseobecna fakultni nemocnice v Praze
  • Onkologicka klinika 2. LF UK a FN Motol
  • Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie
  • MUDr. Nina Zemkova s.r.o. Interni Ambulance
  • Unimed Ajara LLC
  • Clinic LJ Ltd
  • Aleksandre Aladashvili Clinic - LLC
  • Archangel St Michael Multiprofile Clinical Hospital Ltd
  • Emergency Cardiology Center by Academician G. Chapidze Ltd
  • Institute of Clinical Cardiology Ltd
  • Unimed Kakheti - Caraps Medline LLC
  • Unimed Kakheti - Telavi Referral Hospital LLC
  • DRC Gyogyszervizsgalo Kozpont Kft
  • DRC Balatongyorok
  • Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
  • Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Debreceni Egyetem Klinikai Kozpont
  • BKS Research Kft.
  • Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
  • SALVIA Lekston i Madej s.j.
  • Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O
  • AppleTreeClinics Sp. z o.o.
  • NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
  • Nzoz Salusmed
  • MEDICOME Sp. z o.o.
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
  • Centrum Zdrowia Metabolicznego Pawel Bogdanski
  • Praktyka Lekarska Ewa Krzyzagorska
  • Clinmedica Research Omc Sp z o.o. Sp
  • Centrum Kardiologiczne Pro Corde Sp. z o. o.
  • City Clinical Hospital n.a. M.P. Konchalovskiy
  • First City Clinical Hospital n.a. E.E.Volosevich
  • Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
  • Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction
  • Chita State Medical Academy
  • Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District
  • Interregional Clinical Diagnostic Center
  • Kazan State Medical University based at City Clinical Hospital #7
  • Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases"
  • Medical Center "Alliance"
  • Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky
  • Central Clinical Hospital of Russian Academy of Sciences
  • City Clinical Hospital #15 n.a. O.M. Filatov
  • City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department
  • Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
  • National Medical Research Center of Cardiology - Department of Atherosclerosis
  • National Medical Research Center of Cardiology
  • National Medical Research Center of Preventive Medicine
  • Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
  • City Clinical Hospital No.2
  • RC Medical LLC
  • Research Institute of Physiology and Fundamental Medicine
  • Orenburg State Medical University based at City Clinical Hospital #1
  • Clinical-diagnostic center "Zdorovye"
  • Rostov-on-Don City Hospital of Emergency Care
  • Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
  • BioTechService LLC
  • Clinic Complex JSC
  • Limited Liability Company "MedPomosch"
  • Medical Technologies LLC
  • North-Western State Medical University named after I.I. Mechnikov
  • City hospital #38 n.a. N.A. Semashko
  • Regional Clinical Cardiology Dispensary
  • Saratov State Medical University n. a. V.I. Razumovsky
  • Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen
  • Almazov National Medical Research Centre
  • Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency
  • Consultative Diagnostic Center with Out-patient Clinic
  • Tomsk National Research Medical Center of Russian Academy of Sciences
  • Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre
  • Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"
  • Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
  • JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1
  • JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2
  • Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council
  • Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council
  • Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
  • Kyiv City Clinical Hospital #1, Urgent Cardiology Department
  • Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department
  • 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
  • SI "Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine", Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t
  • Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department
  • Small Private Enterprise, Medical Centre "Puls"
  • Municipal Institution "City Clinical Hospital #6", Therapeutic Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

12 Week Efficacy

40 Week Extension

Arm Description

K-877 or placebo comparator twice daily for 12 weeks

K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks

Outcomes

Primary Outcome Measures

Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12

Secondary Outcome Measures

Percent Change From Baseline to Week 12 in Remnant Cholesterol
Percent Change From Baseline to Week 12 in HDL-C
Percent Change From Baseline to Week 12 in Apo A1
Percent Change From Baseline to Week 12 in Non-HDL-C
Percent Change From Baseline to Week 12 in Total Cholesterol
Percent Change From Baseline to Week 12 in LDL-C
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
Percent Change From Baseline to Week 12 in Apo A2
Percent Change From Baseline to Week 12 in Apo B
Percent Change From Baseline to Week 12 in Apo B48
Percent Change From Baseline to Week 12 in Apo B100
Percent Change From Baseline to Week 12 in Apo C2
Percent Change From Baseline to Week 12 in Apo C3
Percent Change From Baseline to Week 12 in Apo E
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
Change From Baseline to Week 12 in hsCRP
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a
Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Percent Change From Baseline to Week 52 in Fasting TG
Percent Change From Baseline to Week 52 in Remnant Cholesterol
Percent Change From Baseline to Week 52 in HDL-C
Percent Change From Baseline to Week 52 in Apo A1
Percent Change From Baseline to Week 52 in Non-HDL-C
Percent Change From Baseline to Week 52 in TC
Percent Change From Baseline to Week 52 in LDL-C
Percent Change From Baseline to Week 52 in FFAs
Percent Change From Baseline to Week 52 in Apo A2
Percent Change From Baseline to Week 52 in Apo B
Percent Change From Baseline to Week 52 in Apo B48
Percent Change From Baseline to Week 52 in Apo B100
Percent Change From Baseline to Week 52 in Apo C2
Percent Change From Baseline to Week 52 in Apo C3
Percent Change From Baseline to Week 52 in Apo E
Change From Baseline to Week 52 in FGF21
Change From Baseline to Week 52 in hsCRP
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a
Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2

Full Information

First Posted
November 29, 2016
Last Updated
November 9, 2022
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03001817
Brief Title
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
Official Title
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 28, 2016 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and <2000 mg/dL and normal renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
551 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 Week Efficacy
Arm Type
Placebo Comparator
Arm Description
K-877 or placebo comparator twice daily for 12 weeks
Arm Title
40 Week Extension
Arm Type
Active Comparator
Arm Description
K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks
Intervention Type
Drug
Intervention Name(s)
K-877
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Type
Drug
Intervention Name(s)
Placebo (for K-877)
Intervention Type
Drug
Intervention Name(s)
Placebo (for Fenofibrate)
Primary Outcome Measure Information:
Title
Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline to Week 12 in Remnant Cholesterol
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in HDL-C
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo A1
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Non-HDL-C
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Total Cholesterol
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in LDL-C
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo A2
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo B
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo B48
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo B100
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo C2
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo C3
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Apo E
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in hsCRP
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a
Description
Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Description
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
Description
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
Time Frame
12 Weeks
Title
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Description
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time Frame
12 Weeks
Title
Percent Change From Baseline to Week 52 in Fasting TG
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Remnant Cholesterol
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in HDL-C
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo A1
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Non-HDL-C
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in TC
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in LDL-C
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in FFAs
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo A2
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo B
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo B48
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo B100
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo C2
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo C3
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Apo E
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in FGF21
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in hsCRP
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a
Description
Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Description
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
Description
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
Time Frame
52 Weeks
Title
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Description
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time Frame
52 Weeks
Title
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent; Aged ≥18 years; 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): 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); 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); 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 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; Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria: Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, criterion 3.a. through 3.d.); Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high-intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference; Exclusion Criteria: Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols; Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6); Patients with type 1 diabetes mellitus; 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);
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Cahaba Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Boyett Health Services Inc
City
Hamilton
State/Province
Alabama
ZIP/Postal Code
35570
Country
United States
Facility Name
Longwood Research - Saadat Ansari, MD, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Terence T. Hart, MD
City
Tuscumbia
State/Province
Alabama
ZIP/Postal Code
35674
Country
United States
Facility Name
Arrowhead Health Centers
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Phoenix Medical Research Institute, LLC
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Research Institute of Arizona, LLC
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
iResearch - Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Downtown L.A. Research Center, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Lucita M. Cruz, MD., Inc.
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Creekside Endocrine Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Atlantic Clinical Research Collaborative
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
ALL Medical Research, LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
S & W Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Jacksonville Impotence Treatment Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
AMPM Research Clinic
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Advanced Research Institute Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Ocala Cardiovascular Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
South Florida Research Solutions LLC. - Pembroke Pines
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Meridien Research - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Columbus Regional Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Physicians Research Associates, Inc
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Georgia Institute for Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Meridian Clinical Research - Savannah, GA
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Apex Medical Research - Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Lemah Creek Clinical Research
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Koch Family Medicine
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
Community Hospital of Anderson and Madison County, Inc
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
American Health Network - Avon Clinical Research Department
City
Avon
State/Province
Indiana
ZIP/Postal Code
46103
Country
United States
Facility Name
Medisphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Buynak Clinical Research, P.C.
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
West Broadway Clinic
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
The Iowa Clinic - Cardiovascular Services
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
The Research Group of Lexington, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Research Integrity LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Clinical Trials Management, LLC - Northshore
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70443
Country
United States
Facility Name
Clinical Trials Management LLC - Southshore
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials of America, LLC - West Monroe, LA
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Maryland Cardiovascular Specialist
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Aa Mrc, Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
David M. Headley, MD P.A.
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150
Country
United States
Facility Name
Consult and Research Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Advance Clinical Research, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Desert Endocrinology Clinical Research Center - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Lakeshore Primary Care Associate
City
Hamburg
State/Province
New York
ZIP/Postal Code
14075
Country
United States
Facility Name
Mid-Hudson Medical Research, PLLC - Hopewell Junction
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Mid-Hudson Medical Research, PLLC - New Windsor
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Orchard Park Family Practice
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Diabetes and Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lillestol Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Sterling Research Group, Ltd. - Auburn
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Alpha Research Associates, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Ohio Clinical Research - Lyndhurst
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Rama Research LLC
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
RAS Health Ltd
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Summit Research Group, LLC
City
Munroe Falls
State/Province
Ohio
ZIP/Postal Code
44262
Country
United States
Facility Name
Ohio Clinical Research, LLC - Willoughby Hills
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
South Oklahoma Heart Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Clinical Research Associates of Central PA, LLC
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Harleysville Medical Associates
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Richard M.Kastelic MD and Associates
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Green and Seidner Family Practice Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Center for Medical Research, LLC
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
DeGarmo Institute Of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
PMG Research of Bristol, LLC - State
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
New Phase Research & Development - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Clinical Research Solutions - Smyrna, TN
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Health Innovation Research Group
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
DCT-AACT, LLC, dba Discovery Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Protenium Clinical Research, LLC - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Academy of Diabetes, Thyroid and Endocrine, P.A.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Juno Research, LLC - Northwest Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Juno Research, LLC - Southwest Houston Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pioneer Research Solutions Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Grace Research, LLC - Huntsville, TX
City
Huntsville
State/Province
Texas
ZIP/Postal Code
77340
Country
United States
Facility Name
Protenium Clinical Research, LLC
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Juno Research, LLC - Katy
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
DCT - McAllen Primary Care, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
San Antonio Premier Internal Medicine
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78220
Country
United States
Facility Name
Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Bandera Family HealthCare Research, LLC (BFHC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
York Clinical Research LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Exemplar Research Inc. - Fairmont, WV
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Allegiance Research Specialists, LLC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Brest Regional Hospital
City
Brest
Country
Belarus
Facility Name
Gomel Regional Clinical Center of Cardiology
City
Gomel
Country
Belarus
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
Country
Belarus
Facility Name
Grodno University Hospital
City
Grodno
Country
Belarus
Facility Name
City Clinical Hospital #10
City
Minsk
Country
Belarus
Facility Name
City Clinical Hospital #1
City
Minsk
Country
Belarus
Facility Name
Minsk Regional Clinical Hospital
City
Minsk
Country
Belarus
Facility Name
Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
City
Minsk
Country
Belarus
Facility Name
Mogilev Regional Medical and Diagnostic Center
City
Mogilev
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
Country
Belarus
Facility Name
Medical Center Diamedical 2013 OOD
City
Dimitrovgrad
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic
City
Pleven
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic
City
Pleven
Country
Bulgaria
Facility Name
UMHAT Sveti Georgi - Clinic of Cardiology
City
Plovdiv
Country
Bulgaria
Facility Name
MHAT Dr. Bratan Shukjerov
City
Smolyan
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
City
Smolyan
Country
Bulgaria
Facility Name
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology
City
Sofia
Country
Bulgaria
Facility Name
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Orfey OOD
City
Stara Zagora
Country
Bulgaria
Facility Name
Lipidova poradna
City
Bilina
Country
Czechia
Facility Name
Medicus Services SRO
City
Brandýs nad Labem
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka
City
Hradec Kralove
Country
Czechia
Facility Name
Ordinace pro choroby srdce a cev
City
Praha 10
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
Country
Czechia
Facility Name
Onkologicka klinika 2. LF UK a FN Motol
City
Praha 5
Country
Czechia
Facility Name
Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie
City
Trutnov
Country
Czechia
Facility Name
MUDr. Nina Zemkova s.r.o. Interni Ambulance
City
Uherské Hradište
Country
Czechia
Facility Name
Unimed Ajara LLC
City
Batumi
Country
Georgia
Facility Name
Clinic LJ Ltd
City
Kutaisi
Country
Georgia
Facility Name
Aleksandre Aladashvili Clinic - LLC
City
Tbilisi
Country
Georgia
Facility Name
Archangel St Michael Multiprofile Clinical Hospital Ltd
City
Tbilisi
Country
Georgia
Facility Name
Emergency Cardiology Center by Academician G. Chapidze Ltd
City
Tbilisi
Country
Georgia
Facility Name
Institute of Clinical Cardiology Ltd
City
Tbilisi
Country
Georgia
Facility Name
Unimed Kakheti - Caraps Medline LLC
City
Tbilisi
Country
Georgia
Facility Name
Unimed Kakheti - Telavi Referral Hospital LLC
City
Telavi
Country
Georgia
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft
City
Balatonfüred
Country
Hungary
Facility Name
DRC Balatongyorok
City
Balatongyorok
Country
Hungary
Facility Name
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
City
Bekescsaba
Country
Hungary
Facility Name
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
City
Budapest
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
Country
Hungary
Facility Name
BKS Research Kft.
City
Hatvan
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
City
Pecs
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
Country
Hungary
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
City
Gdynia
Country
Poland
Facility Name
SALVIA Lekston i Madej s.j.
City
Katowice
Country
Poland
Facility Name
Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O
City
Krakow
Country
Poland
Facility Name
AppleTreeClinics Sp. z o.o.
City
Lodz
Country
Poland
Facility Name
NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
City
Lodz
Country
Poland
Facility Name
Nzoz Salusmed
City
Lodz
Country
Poland
Facility Name
MEDICOME Sp. z o.o.
City
Oswiecim
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
City
Plock
Country
Poland
Facility Name
Centrum Zdrowia Metabolicznego Pawel Bogdanski
City
Poznan
Country
Poland
Facility Name
Praktyka Lekarska Ewa Krzyzagorska
City
Poznan
Country
Poland
Facility Name
Clinmedica Research Omc Sp z o.o. Sp
City
Skierniewice
Country
Poland
Facility Name
Centrum Kardiologiczne Pro Corde Sp. z o. o.
City
Wroclaw
Country
Poland
Facility Name
City Clinical Hospital n.a. M.P. Konchalovskiy
City
Zelenograd
State/Province
Moscow
Country
Russian Federation
Facility Name
First City Clinical Hospital n.a. E.E.Volosevich
City
Arkhangelsk
Country
Russian Federation
Facility Name
Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
City
Arkhangelsk
Country
Russian Federation
Facility Name
Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction
City
Barnaul
Country
Russian Federation
Facility Name
Chita State Medical Academy
City
Chita
Country
Russian Federation
Facility Name
Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District
City
Ekaterinburg
Country
Russian Federation
Facility Name
Interregional Clinical Diagnostic Center
City
Kazan
Country
Russian Federation
Facility Name
Kazan State Medical University based at City Clinical Hospital #7
City
Kazan
Country
Russian Federation
Facility Name
Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases"
City
Kemerovo
Country
Russian Federation
Facility Name
Medical Center "Alliance"
City
Kirovsk
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Central Clinical Hospital of Russian Academy of Sciences
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital #15 n.a. O.M. Filatov
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department
City
Moscow
Country
Russian Federation
Facility Name
Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
City
Moscow
Country
Russian Federation
Facility Name
National Medical Research Center of Cardiology - Department of Atherosclerosis
City
Moscow
Country
Russian Federation
Facility Name
National Medical Research Center of Cardiology
City
Moscow
Country
Russian Federation
Facility Name
National Medical Research Center of Preventive Medicine
City
Moscow
Country
Russian Federation
Facility Name
Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital No.2
City
Novosibirsk
Country
Russian Federation
Facility Name
RC Medical LLC
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Institute of Physiology and Fundamental Medicine
City
Novosibirsk
Country
Russian Federation
Facility Name
Orenburg State Medical University based at City Clinical Hospital #1
City
Orenburg
Country
Russian Federation
Facility Name
Clinical-diagnostic center "Zdorovye"
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Rostov-on-Don City Hospital of Emergency Care
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
City
Saint Petersburg
Country
Russian Federation
Facility Name
BioTechService LLC
City
Saint Petersburg
Country
Russian Federation
Facility Name
Clinic Complex JSC
City
Saint Petersburg
Country
Russian Federation
Facility Name
Limited Liability Company "MedPomosch"
City
Saint Petersburg
Country
Russian Federation
Facility Name
Medical Technologies LLC
City
Saint Petersburg
Country
Russian Federation
Facility Name
North-Western State Medical University named after I.I. Mechnikov
City
Saint Petersburg
Country
Russian Federation
Facility Name
City hospital #38 n.a. N.A. Semashko
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Regional Clinical Cardiology Dispensary
City
Saratov
Country
Russian Federation
Facility Name
Saratov State Medical University n. a. V.I. Razumovsky
City
Saratov
Country
Russian Federation
Facility Name
Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen
City
St-Petersburg
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre
City
St. Petersburg
Country
Russian Federation
Facility Name
Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency
City
St. Petersburg
Country
Russian Federation
Facility Name
Consultative Diagnostic Center with Out-patient Clinic
City
St. Petersburg
Country
Russian Federation
Facility Name
Tomsk National Research Medical Center of Russian Academy of Sciences
City
Tomsk
Country
Russian Federation
Facility Name
Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre
City
Voronezh
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"
City
Yaroslavl
Country
Russian Federation
Facility Name
Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1
City
Kharkiv
Country
Ukraine
Facility Name
JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2
City
Kharkiv
Country
Ukraine
Facility Name
Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council
City
Kharkiv
Country
Ukraine
Facility Name
Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council
City
Kharkiv
Country
Ukraine
Facility Name
Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
City
Kharkiv
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #1, Urgent Cardiology Department
City
Kyiv
Country
Ukraine
Facility Name
Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department
City
Kyiv
Country
Ukraine
Facility Name
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
City
Kyiv
Country
Ukraine
Facility Name
SI "Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine", Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t
City
Kyiv
Country
Ukraine
Facility Name
Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department
City
Odesa
Country
Ukraine
Facility Name
Small Private Enterprise, Medical Centre "Puls"
City
Vinnytsya
Country
Ukraine
Facility Name
Municipal Institution "City Clinical Hospital #6", Therapeutic Department
City
Zaporizhzhia
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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