CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 382 enrolled
Drug / intervention
Bempedoic Acid + Ezetimibe Fixed-Dose Combination +3 morecombination
Likely dose
Bempedoic Acid + Ezetimibe Fixed-Dose Combination 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/NCT03337308
NCT03337308Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy

Esperion Therapeutics, Inc.·interventional·Posted Nov 8, 2017·Updated Apr 8, 2020

In Brief

A Phase 3 clinical trial evaluating Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, and 2 other interventions for Hyperlipidemias. Completed, enrolled 382 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemias
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 8, 2017
Enrollment StartOct 23, 2017
Primary CompletionJun 18, 2018
Study CompletionJul 18, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.7 years ago

Interventions

Bempedoic Acid + Ezetimibe Fixed-Dose Combinationcombination

bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet

Bempedoic Aciddrug

bempedoic acid 180 mg tablet

Ezetimibedrug

ezetimibe 10 mg overencapsulated tablet

Placebosdrug

placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule