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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Esperion Therapeutics
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT02988115
First received: December 7, 2016
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Hypercholesterolemia
Atherosclerotic Cardiovascular Disease
Statin Adverse Reaction
Drug: bempedoic acid
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

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

Estimated Enrollment: 300
Study Start Date: December 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02988115

Contacts
Contact: Stephanie Kelly clinicaltrials@esperion.com

Locations
United States, Wisconsin
Recruiting
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
Study First Received: December 7, 2016
Last Updated: January 3, 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

ClinicalTrials.gov processed this record on April 28, 2017