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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 : Completed
First Posted : December 9, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Tracking Information
First Submitted Date  ICMJE December 7, 2016
First Posted Date  ICMJE December 9, 2016
Last Update Posted Date September 25, 2018
Actual Study Start Date  ICMJE November 15, 2016
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02988115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Atherosclerotic Cardiovascular Disease
  • Statin Adverse Reaction
Intervention  ICMJE
  • Drug: bempedoic acid
    bempedoic acid 180 mg tablet
    Other Name: ETC-1002
  • Other: placebo
    Matching placebo tablet
    Other Name: placebo control
Study Arms  ICMJE
  • Experimental: bempedoic acid
    bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
    Intervention: Drug: bempedoic acid
  • Placebo Comparator: placebo
    Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2017)
345
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2016)
300
Actual Study Completion Date  ICMJE April 16, 2018
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02988115
Other Study ID Numbers  ICMJE 1002-046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esperion Therapeutics
Study Sponsor  ICMJE Esperion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen Nash, MD Esperion Therapeutics
PRS Account Esperion Therapeutics
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP