At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13,970 enrolled
Drug / intervention
Bempedoic acid 180 mg tablet +1 moredrug
Likely dose
Bempedoic acid 180 mg tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Bempedoic acid 180 mg tablet and Matching placebo tablet for Cardiovascular Diseases and Statin Adverse Reaction. Completed, enrolled 13,970 participants across 1,319 sites in 32 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Statin Adverse Reaction
CountriesArgentina, 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, United States
CollaboratorsThe Cleveland Clinic
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartDec 2016
Primary CompletionNov 2022
TodayJul 2026
First PostedDec 15, 2016
Enrollment StartDec 22, 2016
Primary CompletionNov 7, 2022
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.5 years ago
Interventions
Bempedoic acid 180 mg tabletdrug
Patients take bempedoic acid 180 mg tablet orally once daily
Matching placebo tabletdrug
Patients take matching placebo tablet orally once daily