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Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes)

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: NCT02993406
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 9, 2016
First Posted Date  ICMJE December 15, 2016
Last Update Posted Date September 14, 2021
Actual Study Start Date  ICMJE November 18, 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Time from randomization to first occurrence of one of the following adjudicated composite endpoints: CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization. [ Time Frame: 3.75 years (estimated average treatment duration) ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Time from randomization to first occurrence of one of the following adjudicated composite endpoints: CV death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for unstable angina, or coronary revascularization. [ Time Frame: 3.5 years (estimated average treatment duration) ]
Change History
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 Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant
Brief Summary The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients 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
  • Cardiovascular Diseases
  • Statin Adverse Reaction
Intervention  ICMJE
  • Drug: Bempedoic acid 180 mg tablet
    Patients take bempedoic acid 180 mg tablet orally once daily
    Other Name: ETC-1002
  • Drug: Matching placebo tablet
    Patients take matching placebo tablet orally once daily
    Other Name: placebo comparator
Study Arms  ICMJE
  • Experimental: Bempedoic Acid 180 mg
    Bempedoic acid 180 mg tablet taken orally, once daily.
    Intervention: Drug: Bempedoic acid 180 mg tablet
  • Placebo Comparator: Placebo Comparator
    Matching placebo tablet taken orally, once daily
    Intervention: Drug: Matching placebo tablet
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 6, 2020)
14014
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
12600
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 85 years
  • History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
  • Patient reported history of statin intolerance (inability to tolerate 2 or more statins, one at a low dose)
  • Men and nonpregnant, nonlactating women
  • Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening

Exclusion Criteria:

  • Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
  • Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
  • History of severe heart failure
  • Uncontrolled hypertension or uncontrolled diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (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 Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   Germany,   Hungary,   India,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02993406
Other Study ID Numbers  ICMJE 1002-043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Esperion Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Esperion Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE
Study Director: Michael Louie, MD Esperion Therapeutics, Inc.
PRS Account Esperion Therapeutics, Inc.
Verification Date September 2021

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