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Evaluation of ETC-1002 in Patients With Hypercholesterolemia and Hypertension

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ClinicalTrials.gov Identifier: NCT02178098
Recruitment Status : Completed
First Posted : June 30, 2014
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Brief Summary:
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in patients with hypercholesterolemia and hypertension.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypertension Drug: ETC-1002 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension
Study Start Date : June 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ETC-1002
ETC-1002 180 mg/day
Drug: ETC-1002
ETC-1002 capsules taken once daily

Placebo Comparator: Placebo
Placebo control
Drug: Placebo
Placebo capsules taken once daily




Primary Outcome Measures :
  1. Percent change in calculated LDL-cholesterol (LDL-C) [ Time Frame: Baseline to week 6 ]

Secondary Outcome Measures :
  1. Change in 24-hour, day-time and night-time mean systolic blood pressure [ Time Frame: Baseline to week 6 ]
  2. Change in 24-hour, day-time and night-time mean diastolic blood pressure [ Time Frame: Baseline to week 6 ]
  3. Percent change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Baseline to week 6 ]

Other Outcome Measures:
  1. Percent change in non-HDL-C [ Time Frame: Baseline to week 6 ]
  2. Percent change in total cholesterol [ Time Frame: Baseline to week 6 ]
  3. Percent change in apolipoprotein B (ApoB) [ Time Frame: Baseline to week 6 ]
  4. Change in body weight [ Time Frame: Baseline to week 6 ]
    Kg change in body weight from baseline to week 6

  5. Plasma trough study drug pharmacokinetics [ Time Frame: Baseline and week 6 ]
    ETC-1002 and ESP15228 trough plasma concentrations



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
  • or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
  • Fasting LDL-C between 100 and 220 mg/dL
  • Fasting triglycerides less than 400 mg/dL
  • Body mass index (BMI) between 18 and 45 kg/m2

Exclusion Criteria:

  • Known or suspected secondary hypertension or history of malignant hypertension
  • Taking more than two anti-hypertension medications at the first visit
  • History or current clinically significant cardiovascular disease
  • History or current type 1 diabetes or type 2 diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178098


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Arizona
Chandler, Arizona, United States, 85224
Phoenix, Arizona, United States, 85006
United States, Florida
DeLand, Florida, United States, 32720
Fort Lauderdale, Florida, United States, 33306
Hialeah, Florida, United States, 33012
Pembroke Pines, Florida, United States, 33026
Pembroke Pines, Florida, United States, 33029
Port Orange, Florida, United States, 32127
United States, Illinois
Gurnee, Illinois, United States, 60031
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Paducah, Kentucky, United States, 42003
United States, Maine
Auburn, Maine, United States, 04210
United States, Mississippi
Olive Branch, Mississippi, United States, 38654
United States, Montana
Butte, Montana, United States, 59701
United States, Nevada
Las Vegas, Nevada, United States, 89123
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, New York
Endwell, New York, United States, 13760
United States, North Carolina
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45246
Willoughby Hills, Ohio, United States, 44094
United States, Oregon
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Downingtown, Pennsylvania, United States, 19335
United States, South Carolina
Charleston, South Carolina, United States, 29407
Simpsonville, South Carolina, United States, 29681
United States, Texas
Corpus Christi, Texas, United States, 78404
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75234
Houston, Texas, United States, 77074
United States, Utah
Salt Lake City, Utah, United States, 84095
Salt Lake City, Utah, United States, 84107
United States, Wisconsin
Kenosha, Wisconsin, United States, 53142
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Esperion Therapeutics, Inc.
Medpace, Inc.
Investigators
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Study Director: Medpace Medical Monitor, MD Medpace, Inc.
Publications:

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Responsible Party: Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02178098    
Other Study ID Numbers: 1002-014
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Esperion Therapeutics, Inc.:
LDL
Cholesterol
Additional relevant MeSH terms:
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Hypertension
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs