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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

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ClinicalTrials.gov Identifier: NCT03051100
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Bempedoic acid 180mg Drug: Ezetimibe 10mg Drug: Atorvastatin 20mg Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C
Actual Study Start Date : January 19, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : July 5, 2017


Arm Intervention/treatment
Experimental: Triplet Therapy
Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
Drug: Bempedoic acid 180mg
bempedoic acid 180 mg
Other Name: ETC-1002

Drug: Ezetimibe 10mg
ezetimibe 10 mg
Other Name: Zetia

Drug: Atorvastatin 20mg
atorvastatin 20 mg
Other Name: Lipitor

Placebo Comparator: placebo
Matching placebos taken orally, daily.
Other: Placebo
placebo




Primary Outcome Measures :
  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6 [ Time Frame: Baseline; Week 6 ]
    Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF), with only post-Baseline values carried forward. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Lipid Profile Parameters at Week 6 [ Time Frame: Baseline; Week 6 ]
    Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Baseline apolipoprotein B (apoB) was measured only at predose/Day 1. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing values were imputed using LOCF, with only post-Baseline values carried forward. non-HDL-C, non-high-density lipoprotein cholesterol; TC, total cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol.

  2. Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6 [ Time Frame: Baseline; Week 6 ]
    Percent change is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the predose Day 1/Week 0 (Treatment Visit 1) value. If only one value is available either at Week -1 (Screening Visit 2) or Week 0 (Treatment Visit 1), then that value is used as Baseline. Missing values were imputed using LOCF, with only post-Baseline values carried forward.

  3. Number of Participants With LDL-C <70 mg/dL at Week 6 [ Time Frame: Week 6 ]
    Analysis was based on LOCF values. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.

  4. Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6 [ Time Frame: Baseline; Week 6 ]
    If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.



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

Inclusion Criteria:

  • Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
  • Men and nonpregnant, nonlactating women
  • Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks

Exclusion Criteria:

  • Fasting blood triglycerides greater than or equal to 400 mg/dL
  • Body Mass Index (BMI) greater than 50 kg/m2
  • History of clinically significant cardiovascular disease
  • History of type 1 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): NCT03051100


Locations
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United States, Illinois
PMG Research of Christie Clinic
Champaign, Illinois, United States, 61820
United States, North Carolina
PMG Research of Cary
Cary, North Carolina, United States, 27518
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
Sensenbrenner Primary Care
Charlotte, North Carolina, United States, 28277
PMG Research of Hickory
Hickory, North Carolina, United States, 28601
PMG Research of Raleigh
Raleigh, North Carolina, United States, 27609
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States, 27804
PMG Research Salisbury
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, South Carolina
PMG Research of Charleston
Mount Pleasant, South Carolina, United States, 29464
United States, Virginia
Hampton Roads Center for Clinical Research
Virginia Beach, Virginia, United States, 23451
Sponsors and Collaborators
Esperion Therapeutics
Investigators
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Study Director: Ron Haberman, MD Esperion Therapeutics
  Study Documents (Full-Text)

Documents provided by Esperion Therapeutics:
Study Protocol  [PDF] November 11, 2016
Statistical Analysis Plan  [PDF] July 3, 2017

Publications:
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Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT03051100    
Other Study ID Numbers: 1002-038
First Posted: February 13, 2017    Key Record Dates
Results First Posted: April 3, 2020
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esperion Therapeutics:
hyperlididemia
LDL
cholesterol
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs