CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,230 enrolled
Drug / intervention
ETC-1002 +1 moredrug
Likely dose
ETC-1002 180 mgfrom 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.

Search/NCT02666664
NCT02666664Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy

Esperion Therapeutics, Inc.·interventional·Posted Jan 28, 2016·Updated May 11, 2020

In Brief

A Phase 3 clinical trial evaluating ETC-1002 and Placebo for Hypercholesterolemia and Atherosclerotic Cardiovascular Diseases. Completed, enrolled 2,230 participants across 104 sites in 6 countries.

Detailed Summary

The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Atherosclerotic Cardiovascular Diseases
CountriesCanada, Germany, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 28, 2016
Enrollment StartJan 21, 2016
Primary CompletionFeb 21, 2018
Study CompletionMar 28, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.4 years ago

Interventions

ETC-1002drug

ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)

Placebodrug

Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)