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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):

December 7, 2016
December 9, 2016
November 8, 2017
November 15, 2016
April 2018   (Final data collection date for primary outcome measure)
Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]
Same as current
Complete list of historical versions of study NCT02988115 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Atherosclerotic Cardiovascular Disease
  • Statin Adverse Reaction
  • Drug: bempedoic acid
    bempedoic acid 180 mg tablet
    Other Name: ETC-1002
  • Other: placebo
    Matching placebo tablet
    Other Name: placebo control
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
345
July 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02988115
1002-046
Yes
Not Provided
Not Provided
Esperion Therapeutics
Esperion Therapeutics
Not Provided
Study Director: Stephen Nash, MD Esperion Therapeutics
Esperion Therapeutics
November 2017

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