NCT02993406

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13,970 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 participants who have or are at high risk for cardiovascular disease and are statin intolerant.

Conditions

• Cardiovascular Diseases
• Statin Adverse Reaction

Interventions

Type	Name	Description
DRUG	Bempedoic acid 180 mg tablet	Patients take bempedoic acid 180 mg tablet orally once daily
DRUG	Matching placebo tablet	Patients take matching placebo tablet orally once daily

Timeline

• Start date: 2016-12-22
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2016-12-15
• Last updated: 2024-01-03
• Results posted: 2024-01-03

Locations

1,319 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, Germany, Hungary, India, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom