MedPath

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

Phase 3
Completed
Conditions
Severe Hypertriglyceridemia
Interventions
Drug: Placebo (for K-877)
Registration Number
NCT03011450
Lead Sponsor
Kowa Research Institute, Inc.
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 Mild or Moderate Renal Impairment.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
471
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, 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;
  5. Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).

    • Mild to moderate renal impairment eGFR >= 30mL/min/1.73 and < 90 mL/min/1.73 at Visit 1
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);

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
12 Week EfficacyPlacebo (for K-877)K-877 or placebo comparator for 12 weeks
40 week extensionK-877K-877 or fenofibrate comparator for 40 weeks
12 Week EfficacyK-877K-877 or placebo comparator for 12 weeks
40 week extensionFenofibrateK-877 or fenofibrate comparator for 40 weeks
Primary Outcome Measures
NameTimeMethod
Percent Change in Fasting TG From Baseline to Week 1212 Weeks
Secondary Outcome Measures
NameTimeMethod
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)12 Weeks
Percent Change From Baseline to Week 12 in Apo A112 Weeks
Percent Change From Baseline to Week 52 in Apo A252 Weeks
Percent Change From Baseline to Week 52 in Apo B52 Weeks
Percent Change From Baseline to Week 52 in Apo C252 Weeks
Percent Change From Baseline to Week 12 in Apo A212 Weeks
Percent Change From Baseline to Week 12 in Apo B12 Weeks
Percent Change From Baseline to Week 12 in Apo C212 Weeks
Percent Change From Baseline to Week 52 in Apo E52 Weeks
Change From Baseline to Week 52 in hsCRP52 Weeks
Percent Change From Baseline to Week 12 in HDL-C12 Weeks
Percent Change From Baseline to Week 12 in Non-HDL-C12 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C252 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A152 Weeks
Percent Change From Baseline to Week 12 in Remnant Cholesterol12 Weeks
Percent Change From Baseline to Week 12 in Total Cholesterol12 Weeks
Percent Change From Baseline to Week 12 in LDL-C12 Weeks
Percent Change From Baseline to Week 12 in Apo B4812 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)52 Weeks
Percent Change From Baseline to Week 12 in FFAs12 Weeks
Percent Change From Baseline to Week 12 in Apo B10012 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)12 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)12 Weeks
Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B12 Weeks
Percent Change From Baseline to Week 52 in Remnant Cholesterol52 Weeks
Percent Change From Baseline to Week 52 in Apo A152 Weeks
Percent Change From Baseline to Week 52 in Non-HDL-C52 Weeks
Change From Baseline to Week 12 in FGF2112 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)12 Weeks
Percent Change From Baseline to Week 12 in Apo C312 Weeks
Change From Baseline to Week 12 in hsCRP12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)12 Weeks

Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.

Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)12 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C212 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C12 Weeks
Percent Change From Baseline to Week 52 in Fasting TG52 Weeks
Percent Change From Baseline to Week 52 in HDL-C52 Weeks
Percent Change From Baseline to Week 12 in Apo E12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)12 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)12 Weeks
Percent Change From Baseline to Week 52 in TC52 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A112 Weeks
Percent Change From Baseline to Week 52 in Apo B10052 Weeks
Percent Change From Baseline to Week 52 in Apo C352 Weeks
Change From Baseline to Week 52 in FGF2152 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)52 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C52 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C12 Weeks
Percent Change From Baseline to Week 52 in FFAs52 Weeks
Percent Change From Baseline to Week 52 in Apo B4852 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)52 Weeks
Percent Change From Baseline to Week 52 in LDL-C52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)52 Weeks

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 (Å))52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)52 Weeks

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)52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C52 Weeks
Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)52 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C52 Weeks

Trial Locations

Locations (236)

South Florida Research Solutions LLC.

🇺🇸

Pembroke Pines, Florida, 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

Phoenix Medical Research Institute, LLC

🇺🇸

Peoria, Arizona, United States

iResearch

🇺🇸

Decatur, Georgia, United States

Advanced Research Center

🇺🇸

Anaheim, California, United States

Catalina Research Institute, LLC

🇺🇸

Montclair, California, United States

Pacific Coast Cardiology and Research

🇺🇸

Newport Beach, California, United States

Downtown L.A. Research Center, Inc.

🇺🇸

Los Angeles, California, United States

Torrance Clinical Research Institute Inc.

🇺🇸

Lomita, California, United States

Lucita M. Cruz, MD., Inc.

🇺🇸

Norwalk, California, 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

Advanced Research Institute Inc

🇺🇸

New Port Richey, Florida, United States

Jacksonville Impotence Treatment Center

🇺🇸

Jacksonville, Florida, United States

AMPM Research Clinic

🇺🇸

Miami Gardens, Florida, United States

Ocala Cardiovascular Research

🇺🇸

Ocala, Florida, United States

Progressive Medical Research

🇺🇸

Port Orange, Florida, United States

Cardiovascular Center of Sarasota

🇺🇸

Sarasota, 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

Endocrine Research Solutions, Inc

🇺🇸

Roswell, Georgia, United States

Meridian Clinical Research - Savannah, GA

🇺🇸

Savannah, Georgia, United States

Solaris Clinical Research

🇺🇸

Meridian, Idaho, United States

Lemah Creek Clinical Research

🇺🇸

Burr Ridge, Illinois, United States

Koch Family Medicine

🇺🇸

Morton, Illinois, United States

Cedar-Crosse Research Center

🇺🇸

Chicago, Illinois, United States

Apex Medical Research

🇺🇸

Chicago, 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

The Iowa Clinic - Cardiovascular Services

🇺🇸

West Des Moines, Iowa, United States

Buynak Clinical Research, P.C.

🇺🇸

Valparaiso, Indiana, United States

West Broadway Clinic

🇺🇸

Council Bluffs, Iowa, United States

Research Integrity LLC

🇺🇸

Owensboro, Kentucky, United States

Clinical Trials Management, LLC - Northshore

🇺🇸

Covington, Louisiana, United States

Grace Research, LLC

🇺🇸

Huntsville, Texas, United States

Clinical Trials of America, LLC

🇺🇸

West Monroe, Louisiana, United States

Maryland Cardiovascular Specialists

🇺🇸

Baltimore, Maryland, United States

Regeneris Medical

🇺🇸

North Attleboro, Massachusetts, United States

Oakland Medical Research Center

🇺🇸

Troy, Michigan, United States

Aa Mrc, Llc

🇺🇸

Flint, Michigan, United States

Advance Clinical Research, Inc

🇺🇸

Saint Louis, Missouri, United States

Consult and Research Associates

🇺🇸

Saint Louis, Missouri, United States

Glacier View Research Institute

🇺🇸

Kalispell, Montana, United States

Desert Endocrinology Clinical Research Center

🇺🇸

Henderson, Nevada, United States

Lakeshore Primary Care Associate

🇺🇸

Hamburg, New York, United States

Mid-Hudson Medical Research, PLLC - Hopewell Junction

🇺🇸

New Windsor, New York, United States

Orchard Park Family Practice

🇺🇸

Orchard Park, New York, United States

Mid-Hudson Medical Research, PLLC - New Windsor

🇺🇸

New Windsor, New York, United States

Diabetes and Endocrinology Consultants, P.C.

🇺🇸

Morehead City, North Carolina, United States

Lillestol Research, LLC

🇺🇸

Fargo, North Dakota, United States

Alpha Research Associates, LLC

🇺🇸

Dayton, Ohio, United States

Aventiv Research, Inc.

🇺🇸

Columbus, 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

Clinical Research Associates of Central PA, LLC

🇺🇸

Altoona, 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

MDFirst Research - Anderson

🇺🇸

Anderson, South Carolina, 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, Tennessee, United States

Health Innovation Research Group

🇺🇸

Arlington, Texas, United States

Clinical Research Solutions - Smyrna, TN

🇺🇸

Smyrna, Tennessee, United States

Holston Medical Group

🇺🇸

Kingsport, Tennessee, United States

Inquest Clinical Research

🇺🇸

Baytown, Texas, United States

Padre Coast Clinical Research

🇺🇸

Corpus Christi, Texas, United States

Protenium Clinical Research, LLC - Dallas

🇺🇸

Dallas, Texas, United States

Juno Research, LLC

🇺🇸

Katy, Texas, United States

Protenium Clinical Research, LLC

🇺🇸

Hurst, Texas, United States

FMC Science

🇺🇸

Lampasas, 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

Pinnacle Clinical Research

🇺🇸

Live Oak, Texas, United States

DCT - McAllen Primary Care, LLC

🇺🇸

McAllen, Texas, United States

Manassas Clinical Research Center

🇺🇸

Manassas, Virginia, United States

Cardiovascular Associates, Ltd

🇺🇸

Virginia Beach, 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

City Clinical Hospital #1

🇧🇾

Minsk, Belarus

Gomel Regional Clinical Center of Cardiology

🇧🇾

Gomel, Belarus

Grodno University Hospital

🇧🇾

Grodno, Belarus

Mogilev Regional Medical and Diagnostic Center

🇧🇾

Mogilev, Belarus

City Clinical Hospital #9

🇧🇾

Minsk, Belarus

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

MHAT Dr. Bratan Shukjerov

🇧🇬

Smolyan, Bulgaria

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

🇧🇬

Plovdiv, Bulgaria

Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

🇧🇬

Smolyan, Bulgaria

Medicus Services SRO

🇨🇿

Brandýs nad Labem, Czechia

Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka

🇨🇿

Hradec Králové, Czechia

Lipidova poradna

🇨🇿

Bílina, Czechia

Ordinace pro choroby srdce a cev

🇨🇿

Praha 10, Czechia

Vseobecna fakultni nemocnice v Praze

🇨🇿

Praha 2, Czechia

MUDr. Nina Zemkova s.r.o. Interni Ambulance

🇨🇿

Uherské Hradište, Czechia

Fakultni nemocnice v Motole

🇨🇿

Praha 5, Czechia

Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie

🇨🇿

Trutnov, Czechia

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 - Telavi Referral Hospital LLC

🇬🇪

Telavi, Georgia

DRC Gyogyszervizsgalo Kozpont Kft

🇭🇺

Balatonfüred, Hungary

DRC Balatongyorok

🇭🇺

Balatongyörök, Hungary

Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly

🇭🇺

Budapest, Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

🇭🇺

Budapest, Hungary

BKS Research Kft.

🇭🇺

Hatvan, Hungary

Debreceni Egyetem Klinikai Kozpont

🇭🇺

Debrecen, Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

🇭🇺

Székesfehérvár, Hungary

MEDICOME Sp. z o.o.

🇵🇱

Oświęcim, Poland

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

🇵🇱

Gdynia, Poland

Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O

🇵🇱

Krakow, Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski

🇵🇱

Poznań, Poland

Centrum Kardiologiczne Pro Corde Sp. z o. o.

🇵🇱

Wrocław, Poland

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O

🇵🇱

Płock, Poland

NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek

🇵🇱

Łódź, Poland

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

🇷🇺

Arkhangelsk, Russian Federation

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

🇷🇺

Barnaul, Russian Federation

Chita State Medical Academy

🇷🇺

Chita, Russian Federation

Kazan State Medical University based at City Clinical Hospital #7

🇷🇺

Kazan, Russian Federation

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

🇷🇺

Kemerovo, Russian Federation

Medical Center Alliance

🇷🇺

Kirovsk, Russian Federation

National Medical Research Center of Preventive Medicine

🇷🇺

Moscow, Russian Federation

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

🇷🇺

Krasnoyarsk, Russian Federation

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

🇷🇺

Moscow, Russian Federation

Central Clinical Hospital of Russian Academy of Sciences

🇷🇺

Moscow, Russian Federation

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

🇷🇺

Moscow, Russian Federation

National Medical Research Center of Cardiology - Department of Atherosclerosis

🇷🇺

Moscow, Russian Federation

National Medical Research Center of Cardiology

🇷🇺

Moscow, Russian Federation

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

🇷🇺

Moscow, Russian Federation

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

🇷🇺

Moscow, Russian Federation

Clinical-diagnostic center Zdorovye

🇷🇺

Rostov-on-Don, Russian Federation

North-Western State Medical University named after I.I. Mechnikov

🇷🇺

Saint Petersburg, Russian Federation

Medical Technologies LLC

🇷🇺

Saint Petersburg, Russian Federation

Limited Liability Company MedPomosch

🇷🇺

Saint Petersburg, Russian Federation

City hospital #38 n.a. N.A. Semashko

🇷🇺

Saint Petersburg, Russian Federation

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

🇷🇺

Saratov, Russian Federation

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

🇷🇺

St. Petersburg, Russian Federation

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

🇷🇺

Voronezh, Russian Federation

Tomsk National Research Medical Center of Russian Academy of Sciences

🇷🇺

Tomsk, Russian Federation

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

🇷🇺

Yaroslavl, Russian Federation

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

🇺🇦

Kharkiv, Ukraine

Kharkiv Medical Academy of Postgraduate Education

🇺🇦

Kharkiv, Ukraine

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

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

Centex Studies, Inc.

🇺🇸

Houston, Texas, United States

Pioneer Research Solutions Inc.

🇺🇸

Houston, Texas, United States

Midwest Institute for Clinical Research

🇺🇸

Indianapolis, Indiana, United States

Palm Research Center, Inc.

🇺🇸

Las Vegas, Nevada, United States

Sterling Research Group, Ltd. - Auburn

🇺🇸

Cincinnati, Ohio, United States

Integrated Research Center

🇺🇸

San Diego, California, 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

Bandera Family HealthCare Research, LLC (BFHC)

🇺🇸

San Antonio, Texas, United States

Optimus Medical Group

🇺🇸

San Francisco, California, United States

Professional Research Network of Kansas, LLC

🇺🇸

Wichita, Kansas, United States

Elite Clinical Studies

🇺🇸

Phoenix, Arizona, United States

COR Clinical Research, LLC.

🇺🇸

Oklahoma City, Oklahoma, United States

South Oklahoma Heart Research

🇺🇸

Oklahoma City, Oklahoma, United States

Central Research Associates, Inc.

🇺🇸

Birmingham, Alabama, United States

Central Alabama Research

🇺🇸

Birmingham, Alabama, United States

Cahaba Research, Inc.

🇺🇸

Birmingham, Alabama, United States

Creekside Endocrine Associates, PC

🇺🇸

Denver, Colorado, United States

Arrowhead Health Centers

🇺🇸

Glendale, Arizona, United States

Clinical Research Institute of Arizona, LLC

🇺🇸

Surprise, Arizona, United States

Brest Regional Hospital

🇧🇾

Brest, Belarus

City Clinical Hospital #10

🇧🇾

Minsk, Belarus

Medical Center Diamedical 2013 OOD

🇧🇬

Dimitrovgrad, Bulgaria

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

🇧🇬

Sofia, Bulgaria

Unimed Kakheti - Caraps Medline LLC

🇬🇪

Tbilisi, Georgia

Clinical Trials Management LLC - Southshore

🇺🇸

Metairie, Louisiana, United States

Gomel Regional Clinical Hospital

🇧🇾

Gomel, Belarus

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

🇧🇬

Sofia, Bulgaria

Praktyka Lekarska Ewa Krzyzagorska

🇵🇱

Poznań, Poland

Research Institute of Physiology and Fundamental Medicine

🇷🇺

Novosibirsk, Russian Federation

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

🇺🇦

Kharkiv, Ukraine

MD First Research

🇺🇸

Lancaster, South Carolina, United States

Family Medicine of SayeBrook

🇺🇸

Myrtle Beach, South Carolina, United States

Chattanooga Research & Medicine, PLLC

🇺🇸

Chattanooga, Tennessee, United States

Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology

🇧🇾

Minsk, Belarus

Minsk Regional Clinical Hospital

🇧🇾

Minsk, Belarus

Medical Center Orfey OOD

🇧🇬

Stara Zagora, Bulgaria

Vitebsk Regional Clinical Hospital

🇧🇾

Vitebsk, Belarus

Unimed Ajara LLC

🇬🇪

Batumi, Georgia

Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

🇭🇺

Békéscsaba, Hungary

Clinmedica Research Omc Sp z o.o. Sp

🇵🇱

Skierniewice, Poland

RC Medical LLC

🇷🇺

Novosibirsk, Russian Federation

Orenburg State Medical University based at City Clinical Hospital #1

🇷🇺

Orenburg, Russian Federation

BioTechService LLC

🇷🇺

Saint Petersburg, Russian Federation

Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika

🇭🇺

Pécs, Hungary

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

🇷🇺

Arkhangelsk, Russian Federation

SALVIA Lekston i Madej s.j.

🇵🇱

Katowice, Poland

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

🇷🇺

Ekaterinburg, Russian Federation

Consultative Diagnostic Center with Out-patient Clinic

🇷🇺

Saint Petersburg, Russian Federation

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

🇷🇺

Saint Petersburg, Russian Federation

AppleTreeClinics Sp. z o.o.

🇵🇱

Łódź, Poland

Nzoz Salusmed

🇵🇱

Łódź, Poland

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

🇷🇺

Moscow, Russian Federation

Interregional Clinical Diagnostic Center

🇷🇺

Kazan, Russian Federation

City Clinical Hospital No.2

🇷🇺

Novosibirsk, Russian Federation

Rostov-on-Don City Hospital of Emergency Care

🇷🇺

Rostov-on-Don, Russian Federation

Clinic Complex JSC

🇷🇺

Saint Petersburg, Russian Federation

Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology

🇷🇺

Saint Petersburg, Russian Federation

Regional Clinical Cardiology Dispensary

🇷🇺

Saratov, Russian Federation

Almazov National Medical Research Centre

🇷🇺

St. Petersburg, Russian Federation

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

🇺🇦

Ivano-Frankivs'k, Ukraine

Small Private Enterprise, Medical Centre Puls

🇺🇦

Vinnytsya, Ukraine

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

🇺🇦

Kharkiv, Ukraine

Kyiv City Clinical Hospital #1, Urgent Cardiology Department

🇺🇦

Kyiv, Ukraine

Municipal Institution City Clinical Hospital #6, Therapeutic Department

🇺🇦

Zaporizhzhia, Ukraine

Meridien Research - Tampa

🇺🇸

Tampa, Florida, United States

Meridien Research

🇺🇸

Tampa, Florida, United States

DCT-AACT, LLC, dba Discovery Clinical Trials

🇺🇸

Austin, Texas, United States

Kentucky Diabetes Endocrinology Center

🇺🇸

Lexington, Kentucky, United States

The Research Group of Lexington, LLC

🇺🇸

Lexington, Kentucky, United States

Lovelace Scientific Resources

🇺🇸

Albuquerque, New Mexico, United States

Lynn Institute of the Ozarks

🇺🇸

Little Rock, Arkansas, United States

Harleysville Medical Associates

🇺🇸

Harleysville, Pennsylvania, United States

David M. Headley, MD P.A.

🇺🇸

Port Gibson, Mississippi, United States

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