Clinical trial NCT03001817: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Hypertriglyceridemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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);

Primary outcomes:
measure: Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percent Change From Baseline to Week 12 in Remnant Cholesterol
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in HDL-C
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo A1
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Non-HDL-C
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Total Cholesterol
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in LDL-C
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo A2
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo B
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo B48
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo B100
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo C2
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo C3
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo E
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in hsCRP
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 52 in Fasting TG
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Remnant Cholesterol
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in HDL-C
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo A1
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Non-HDL-C
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in TC
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in LDL-C
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in FFAs
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo A2
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo B
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo B48
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo B100
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo C2
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo C3
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo E
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in FGF21
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in hsCRP
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
timeFrame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research, Inc.
state: Alabama
city: Hamilton
country: United States
facility: Boyett Health Services Inc
state: Alabama
city: Huntsville
country: United States
facility: Longwood Research - Saadat Ansari, MD, LLC
state: Alabama
city: Tuscumbia
country: United States
facility: Terence T. Hart, MD
state: Alabama
city: Glendale
country: United States
facility: Arrowhead Health Centers
state: Arizona
city: Peoria
country: United States
facility: Phoenix Medical Research Institute, LLC
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Surprise
country: United States
facility: Clinical Research Institute of Arizona, LLC
state: Arizona
city: Little Rock
country: United States
facility: iResearch - Little Rock
state: Arkansas
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc.
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz, MD., Inc.
state: California
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Boynton Beach
country: United States
facility: Atlantic Clinical Research Collaborative
state: Florida
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: S & W Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Impotence Treatment Center
state: Florida
city: Miami Gardens
country: United States
facility: AMPM Research Clinic
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute Inc
state: Florida
city: Ocala
country: United States
facility: Ocala Cardiovascular Research
state: Florida
city: Pembroke Pines
country: United States
facility: South Florida Research Solutions LLC. - Pembroke Pines
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Tampa
country: United States
facility: Meridien Research - Tampa
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Health
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, Inc
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research - Savannah, GA
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Apex Medical Research - Illinois
state: Illinois
city: Melrose Park
country: United States
facility: Lemah Creek Clinical Research
state: Illinois
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Anderson
country: United States
facility: Community Hospital of Anderson and Madison County, Inc
state: Indiana
city: Avon
country: United States
facility: American Health Network - Avon Clinical Research Department
state: Indiana
city: Evansville
country: United States
facility: Medisphere Medical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Council Bluffs
country: United States
facility: West Broadway Clinic
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic - Cardiovascular Services
state: Iowa
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Lexington
country: United States
facility: The Research Group of Lexington, LLC
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity LLC
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Northshore
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management LLC - Southshore
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America, LLC - West Monroe, LA
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialist
state: Maryland
city: Flint
country: United States
facility: Aa Mrc, Llc
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Port Gibson
country: United States
facility: David M. Headley, MD P.A.
state: Mississippi
city: Saint Louis
country: United States
facility: Consult and Research Associates
state: Missouri
city: Saint Louis
country: United States
facility: Advance Clinical Research, Inc
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Henderson
country: United States
facility: Desert Endocrinology Clinical Research Center - Henderson
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.
state: Nevada
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Hamburg
country: United States
facility: Lakeshore Primary Care Associate
state: New York
city: New Windsor
country: United States
facility: Mid-Hudson Medical Research, PLLC - Hopewell Junction
state: New York
city: New Windsor
country: United States
facility: Mid-Hudson Medical Research, PLLC - New Windsor
state: New York
city: Orchard Park
country: United States
facility: Orchard Park Family Practice
state: New York
city: Morehead City
country: United States
facility: Diabetes and Endocrinology Consultants, P.C.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd. - Auburn
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Alpha Research Associates, LLC
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Lyndhurst
country: United States
facility: Ohio Clinical Research - Lyndhurst
state: Ohio
city: Marion
country: United States
facility: Rama Research LLC
state: Ohio
city: Marion
country: United States
facility: RAS Health Ltd
state: Ohio
city: Munroe Falls
country: United States
facility: Summit Research Group, LLC
state: Ohio
city: Willoughby Hills
country: United States
facility: Ohio Clinical Research, LLC - Willoughby Hills
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Altoona
country: United States
facility: Clinical Research Associates of Central PA, LLC
state: Pennsylvania
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Johnstown
country: United States
facility: Richard M.Kastelic MD and Associates
state: Pennsylvania
city: Lansdale
country: United States
facility: Green and Seidner Family Practice Associates
state: Pennsylvania
city: Providence
country: United States
facility: Center for Medical Research, LLC
state: Rhode Island
city: Greer
country: United States
facility: DeGarmo Institute Of Medical Research
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC - State
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development - Knoxville
state: Tennessee
city: Smyrna
country: United States
facility: Clinical Research Solutions - Smyrna, TN
state: Tennessee
city: Arlington
country: United States
facility: Health Innovation Research Group
state: Texas
city: Austin
country: United States
facility: DCT-AACT, LLC, dba Discovery Clinical Trials
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Dallas
country: United States
facility: Protenium Clinical Research, LLC - Dallas
state: Texas
city: Dallas
country: United States
facility: VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)
state: Texas
city: El Paso
country: United States
facility: Academy of Diabetes, Thyroid and Endocrine, P.A.
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC - Northwest Site
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC - Southwest Houston Site
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc.
state: Texas
city: Huntsville
country: United States
facility: Grace Research, LLC - Huntsville, TX
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research, LLC
state: Texas
city: Katy
country: United States
facility: Juno Research, LLC - Katy
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: McAllen
country: United States
facility: DCT - McAllen Primary Care, LLC
state: Texas
city: San Antonio
country: United States
facility: San Antonio Premier Internal Medicine
state: Texas
city: San Antonio
country: United States
facility: Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Bandera Family HealthCare Research, LLC (BFHC)
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: York Clinical Research LLC
state: Virginia
city: Morgantown
country: United States
facility: Exemplar Research Inc. - Fairmont, WV
state: West Virginia
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Brest
country: Belarus
facility: Brest Regional Hospital
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Center of Cardiology
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Hospital
city: Grodno
country: Belarus
facility: Grodno University Hospital
city: Minsk
country: Belarus
facility: City Clinical Hospital #10
city: Minsk
country: Belarus
facility: City Clinical Hospital #1
city: Minsk
country: Belarus
facility: Minsk Regional Clinical Hospital
city: Minsk
country: Belarus
facility: Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
city: Mogilev
country: Belarus
facility: Mogilev Regional Medical and Diagnostic Center
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Dimitrovgrad
country: Bulgaria
facility: Medical Center Diamedical 2013 OOD
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi - Clinic of Cardiology
city: Smolyan
country: Bulgaria
facility: MHAT Dr. Bratan Shukjerov
city: Smolyan
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
city: Sofia
country: Bulgaria
facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology
city: Sofia
country: Bulgaria
facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases
city: Stara Zagora
country: Bulgaria
facility: Medical Center Orfey OOD
city: Bilina
country: Czechia
facility: Lipidova poradna
city: Brandýs nad Labem
country: Czechia
facility: Medicus Services SRO
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka
city: Praha 10
country: Czechia
facility: Ordinace pro choroby srdce a cev
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czechia
facility: Onkologicka klinika 2. LF UK a FN Motol
city: Trutnov
country: Czechia
facility: Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie
city: Uherské Hradište
country: Czechia
facility: MUDr. Nina Zemkova s.r.o. Interni Ambulance
city: Batumi
country: Georgia
facility: Unimed Ajara LLC
city: Kutaisi
country: Georgia
facility: Clinic LJ Ltd
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic - LLC
city: Tbilisi
country: Georgia
facility: Archangel St Michael Multiprofile Clinical Hospital Ltd
city: Tbilisi
country: Georgia
facility: Emergency Cardiology Center by Academician G. Chapidze Ltd
city: Tbilisi
country: Georgia
facility: Institute of Clinical Cardiology Ltd
city: Tbilisi
country: Georgia
facility: Unimed Kakheti - Caraps Medline LLC
city: Telavi
country: Georgia
facility: Unimed Kakheti - Telavi Referral Hospital LLC
city: Balatonfüred
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft
city: Balatongyorok
country: Hungary
facility: DRC Balatongyorok
city: Bekescsaba
country: Hungary
facility: Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
city: Budapest
country: Hungary
facility: Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Hatvan
country: Hungary
facility: BKS Research Kft.
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Gdynia
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
city: Katowice
country: Poland
facility: SALVIA Lekston i Madej s.j.
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O
city: Lodz
country: Poland
facility: AppleTreeClinics Sp. z o.o.
city: Lodz
country: Poland
facility: NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
city: Lodz
country: Poland
facility: Nzoz Salusmed
city: Oswiecim
country: Poland
facility: MEDICOME Sp. z o.o.
city: Plock
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego Pawel Bogdanski
city: Poznan
country: Poland
facility: Praktyka Lekarska Ewa Krzyzagorska
city: Skierniewice
country: Poland
facility: Clinmedica Research Omc Sp z o.o. Sp
city: Wroclaw
country: Poland
facility: Centrum Kardiologiczne Pro Corde Sp. z o. o.
city: Zelenograd
country: Russian Federation
facility: City Clinical Hospital n.a. M.P. Konchalovskiy
state: Moscow
city: Arkhangelsk
country: Russian Federation
facility: First City Clinical Hospital n.a. E.E.Volosevich
city: Arkhangelsk
country: Russian Federation
facility: Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
city: Barnaul
country: Russian Federation
facility: Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction
city: Chita
country: Russian Federation
facility: Chita State Medical Academy
city: Ekaterinburg
country: Russian Federation
facility: Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District
city: Kazan
country: Russian Federation
facility: Interregional Clinical Diagnostic Center
city: Kazan
country: Russian Federation
facility: Kazan State Medical University based at City Clinical Hospital #7
city: Kemerovo
country: Russian Federation
facility: Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases"
city: Kirovsk
country: Russian Federation
facility: Medical Center "Alliance"
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #15 n.a. O.M. Filatov
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Cardiology - Department of Atherosclerosis
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Cardiology
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Preventive Medicine
city: Moscow
country: Russian Federation
facility: Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital No.2
city: Novosibirsk
country: Russian Federation
facility: RC Medical LLC
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Physiology and Fundamental Medicine
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical University based at City Clinical Hospital #1
city: Rostov-on-Don
country: Russian Federation
facility: Clinical-diagnostic center "Zdorovye"
city: Rostov-on-Don
country: Russian Federation
facility: Rostov-on-Don City Hospital of Emergency Care
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
city: Saint Petersburg
country: Russian Federation
facility: BioTechService LLC
city: Saint Petersburg
country: Russian Federation
facility: Clinic Complex JSC
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "MedPomosch"
city: Saint Petersburg
country: Russian Federation
facility: Medical Technologies LLC
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I.I. Mechnikov
city: Saint-Petersburg
country: Russian Federation
facility: City hospital #38 n.a. N.A. Semashko
city: Saratov
country: Russian Federation
facility: Regional Clinical Cardiology Dispensary
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n. a. V.I. Razumovsky
city: St-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen
city: St. Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: St. Petersburg
country: Russian Federation
facility: Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency
city: St. Petersburg
country: Russian Federation
facility: Consultative Diagnostic Center with Out-patient Clinic
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of Russian Academy of Sciences
city: Voronezh
country: Russian Federation
facility: Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
city: Kharkiv
country: Ukraine
facility: JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1
city: Kharkiv
country: Ukraine
facility: JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2
city: Kharkiv
country: Ukraine
facility: Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1, Urgent Cardiology Department
city: Kyiv
country: Ukraine
facility: Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department
city: Kyiv
country: Ukraine
facility: 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: SI "Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine", Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t
city: Odesa
country: Ukraine
facility: Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department
city: Vinnytsya
country: Ukraine
facility: Small Private Enterprise, Medical Centre "Puls"
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution "City Clinical Hospital #6", Therapeutic Department
Study officials:
References: