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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant (CLEAR Serenity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02988115
Recruitment Status : Active, not recruiting
First Posted : December 9, 2016
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Atherosclerotic Cardiovascular Disease Statin Adverse Reaction Drug: bempedoic acid Other: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: bempedoic acid
bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Drug: bempedoic acid
bempedoic acid 180 mg tablet
Other Name: ETC-1002
Placebo Comparator: placebo
Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Other: placebo
Matching placebo tablet
Other Name: placebo control


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
  • Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
  • Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion Criteria:

  • Total fasting triglyceride ≥500 mg/dL
  • Renal dysfunction or nephrotic syndrome or history of nephritis
  • Body Mass Index (BMI) ≥50 kg/m2
  • Significant cardiovascular disease or cardiovascular event in the past 3 months
Contacts and Locations

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): NCT02988115


Locations
United States, Wisconsin
Kenosha, Wisconsin, United States
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Stephen Nash, MD Esperion Therapeutics
More Information

Additional Information:
Publications:
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT02988115     History of Changes
Other Study ID Numbers: 1002-046
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Esperion Therapeutics:
hyperlipidemia
cholesterol
familial hypercholesterolemia
atherosclerotic cardiovascular disease
ASCVD
HeFH
LDL
statin intolerence

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