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Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (CLEAR Wisdom)

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ClinicalTrials.gov Identifier: NCT02991118
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Tracking Information
First Submitted Date  ICMJE December 9, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date November 12, 2018
Actual Study Start Date  ICMJE November 18, 2016
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 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 NCT02991118 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 Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
Official Title  ICMJE A Long-term, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk Not Adequately Controlled by Their Lipid-Modifying Therapy
Brief Summary The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.
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
Intervention  ICMJE
  • Drug: bempedoic acid
    bempedoic acid 180 mg tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
    Other Name: ETC-1002
  • Drug: placebo
    Matching placebo tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
    Other Name: placebo control
Study Arms  ICMJE
  • Active Comparator: bempedoic acid
    bempedoic acid 180 mg/day
    Intervention: Drug: bempedoic acid
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Drug: 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)
779
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2016)
750
Actual Study Completion Date  ICMJE September 25, 2018
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fasting LDL-C ≥100 mg/dL
  • High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
  • Be on maximally tolerated lipid-modifying therapy

Exclusion Criteria:

  • Total fasting triglyceride ≥500 mg/dL
  • Renal dysfunction or nephrotic syndrome or history of nephritis
  • Body Mass Index (BMI) ≥50kg/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 NCT02991118
Other Study ID Numbers  ICMJE 1002-047
2016-003486-26 ( EudraCT Number )
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 November 2018

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