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



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:3/23/2019
Start Date:December 2016
End Date:March 2022
Contact:Maggie Horner, BA, MBA
Email:clinicaltrials@esperion.com
Phone:734-887-3903

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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

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.


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
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