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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

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ClinicalTrials.gov Identifier: NCT03001076
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Atherosclerosis Statin Adverse Reaction Drug: Bempedoic acid Drug: Ezetimibe Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 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, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC 1002) 180 mg/Day as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : February 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arm Intervention/treatment
Experimental: bempedoic acid
bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
Drug: Bempedoic acid
bempedoic acid 180 mg tablet
Other Name: ETC-1002

Drug: Ezetimibe
ezetimibe 10 mg tablet
Other Name: Zetia

Placebo Comparator: placebo
Matching placebo tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
Drug: Ezetimibe
ezetimibe 10 mg tablet
Other Name: Zetia

Other: Placebo
matching placebo tablet
Other Name: placebo control




Primary Outcome Measures :
  1. Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]


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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 greater than or equal to 100 mg/dL at screening
  • Men and nonpregnant, nonlactating women
  • Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that includes ezetimibe 10mg daily

Exclusion Criteria:

  • Fasting blood triglycerides greater than or equal to 500 mg/dL
  • Body Mass Index (BMI) greater than or equal to 50 kg/m2
  • Recent history of clinically significant cardiovascular disease
  • Use of statin therapy where doses are greater than those defined as "low-dose" within 4 weeks prior to screening; where "low-dose" is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.

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): NCT03001076


Locations
United States, Texas
Georgetown, Texas, United States, 78626
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Stephen Nash, MD Esperion Therapeutics

Publications:
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT03001076     History of Changes
Other Study ID Numbers: 1002-048
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Esperion Therapeutics:
hyperlididemia
LDL
cholesterol
statin intolerance

Additional relevant MeSH terms:
Atherosclerosis
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents