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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Esperion Therapeutics
Sponsor:
Collaborator:
Cleveland Clinic Coordinating Center for Clinical Research (C5 Research)
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT02993406
First received: December 9, 2016
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Cardiovascular Diseases Statin Adverse Reaction Drug: Bempedoic acid 180 mg tablet Drug: Matching placebo tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • 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) ]

Estimated Enrollment: 12600
Study Start Date: December 2016
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bempedoic Acid 180 mg
Bempedoic acid 180 mg tablet taken orally, once daily.
Drug: Bempedoic acid 180 mg tablet
Patients take bempedoic acid 180 mg tablet orally once daily
Other Name: ETC-1002
Placebo Comparator: Placebo Comparator
Matching placebo tablet taken orally, once daily
Drug: Matching placebo tablet
Patients take matching placebo tablet orally once daily
Other Name: placebo comparator

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 between 100 and 190 mg/dL at screening
  • 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

Exclusion Criteria:

  • Fasting blood triglycerides greater than 500 mg/dL at screening
  • Recent history of certain cardiovascular disease including transient ischemic attack (TIA), unstable or symptomatic cardiac arrhythmia, use of an implantable pacemaker or implantable cardioverter defibrillators, or coronary revascularization procedure
  • History of heart failure
  • Uncontrolled hypertension
  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: NCT02993406

Contacts
Contact: Maggie Horner clinicaltrials@esperion.com

Locations
United States, Alabama
Recruiting
Tuscumbia, Alabama, United States, 35674
United States, Florida
Recruiting
Pembroke Pines, Florida, United States, 33026
United States, North Carolina
Recruiting
Greensboro, North Carolina, United States, 27408
United States, Virginia
Recruiting
Suffolk, Virginia, United States, 23435
Sponsors and Collaborators
Esperion Therapeutics
Cleveland Clinic Coordinating Center for Clinical Research (C5 Research)
Investigators
Study Director: Stephen Nash, MD Esperion Therapeutics
  More Information