Clinical trial NCT03011450: Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
Official title: A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label 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 Mild or Moderate Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Hypertriglyceridemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 471
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 Mild or Moderate Renal Impairment.


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, 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);

Primary outcomes:
measure: Percent Change in Fasting TG 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 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 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 (VLDL Cholesterol-Large)
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (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 (Diameter of the Major LDL Particle (Å))
timeFrame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)
timeFrame: 12 Weeks
measure: 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: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (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)
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: 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)
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 (Total)
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 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: 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 (Å))
timeFrame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)
timeFrame: 52 Weeks
measure: 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: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)
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: 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: 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
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: Newport Beach
country: United States
facility: Pacific Coast Cardiology and Research
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz, MD., Inc.
state: California
city: San Diego
country: United States
facility: Integrated Research Center
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
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.
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: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Health
state: Georgia
city: Decatur
country: United States
facility: iResearch
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: Roswell
country: United States
facility: Endocrine Research Solutions, Inc
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: Burr Ridge
country: United States
facility: Lemah Creek Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Apex Medical 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: Kentucky Diabetes Endocrinology Center
state: Kentucky
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: Shreveport
country: United States
facility: Grace Research, LLC
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists
state: Maryland
city: North Attleboro
country: United States
facility: Regeneris Medical
state: Massachusetts
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
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: COR Clinical Research, LLC.
state: Oklahoma
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: Anderson
country: United States
facility: MD First Research
state: South Carolina
city: Anderson
country: United States
facility: MDFirst Research - Anderson
state: South Carolina
city: Greer
country: United States
facility: DeGarmo Institute Of Medical Research
state: South Carolina
city: Lancaster
country: United States
facility: MD First Research
state: South Carolina
city: Myrtle Beach
country: United States
facility: Family Medicine of SayeBrook
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: Chattanooga
country: United States
facility: Chattanooga Research & Medicine, PLLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development
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: Corpus Christi
country: United States
facility: Padre Coast 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
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc.
state: Texas
city: Huntsville
country: United States
facility: Grace Research, LLC
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research, LLC
state: Texas
city: Katy
country: United States
facility: Juno Research, LLC
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Live Oak
country: United States
facility: Pinnacle Clinical Research
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: 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: Virginia Beach
country: United States
facility: Cardiovascular Associates, Ltd
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 Hospital
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Center of Cardiology
city: Grodno
country: Belarus
facility: Grodno University Hospital
city: Minsk
country: Belarus
facility: City Clinical Hospital #1
city: Minsk
country: Belarus
facility: City Clinical Hospital #9
city: Minsk
country: Belarus
facility: Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
city: Minsk
country: Belarus
facility: City Clinical Hospital #10
city: Minsk
country: Belarus
facility: Minsk Regional Clinical Hospital
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: University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - 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: Brandýs nad Labem
country: Czechia
facility: Medicus Services SRO
city: Bílina
country: Czechia
facility: Lipidova poradna
city: Hradec Králové
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: Fakultni nemocnice v Motole
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: Balatongyörök
country: Hungary
facility: DRC Balatongyorok
city: Budapest
country: Hungary
facility: Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Békéscsaba
country: Hungary
facility: Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Hatvan
country: Hungary
facility: BKS Research Kft.
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
city: Székesfehérvár
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: Oświęcim
country: Poland
facility: MEDICOME Sp. z o.o.
city: Poznań
country: Poland
facility: Centrum Zdrowia Metabolicznego Pawel Bogdanski
city: Poznań
country: Poland
facility: Praktyka Lekarska Ewa Krzyzagorska
city: Płock
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
city: Skierniewice
country: Poland
facility: Clinmedica Research Omc Sp z o.o. Sp
city: Wrocław
country: Poland
facility: Centrum Kardiologiczne Pro Corde Sp. z o. o.
city: Łódź
country: Poland
facility: AppleTreeClinics Sp. z o.o.
city: Łódź
country: Poland
facility: Nzoz Salusmed
city: Łódź
country: Poland
facility: NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
city: Arkhangelsk
country: Russian Federation
facility: Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
city: Arkhangelsk
country: Russian Federation
facility: First City Clinical Hospital n.a. E.E.Volosevich
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: National Medical Research Center of Preventive Medicine
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #15 n.a. O.M. Filatov
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare 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: City Clinical Hospital n.a. M.P. Konchalovskiy
city: Moscow
country: Russian Federation
facility: Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
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: Clinic Complex JSC
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I.I. Mechnikov
city: Saint Petersburg
country: Russian Federation
facility: Medical Technologies LLC
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company MedPomosch
city: Saint Petersburg
country: Russian Federation
facility: City hospital #38 n.a. N.A. Semashko
city: Saint Petersburg
country: Russian Federation
facility: BioTechService LLC
city: Saint Petersburg
country: Russian Federation
facility: Consultative Diagnostic Center with Out-patient Clinic
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Department of Cardiology N.3
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: 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: 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-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department
city: Kharkiv
country: Ukraine
facility: Kharkiv Medical Academy of Postgraduate Education
city: Kharkiv
country: Ukraine
facility: Kharkiv Railway Clinic. Hosp.#1, Branch Office of "Healthcare Center" of PJSC "Ukr. Railways", Cardiology Depart #2
city: Kharkiv
country: Ukraine
facility: Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1
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 Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1
city: Kyiv
country: Ukraine
facility: Limited Liability Company Treatment and Diagnostic Center Adonis Plus, Outpatient Department
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1, Urgent Cardiology 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: