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
Phase of Trial: Phase III
Latest Information Update: 28 Oct 2018
At a glance
- Drugs Bempedoic acid/ezetimibe (Primary) ; Bempedoic acid; Ezetimibe
- Indications Cardiovascular disorders; Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Sponsors Esperion Therapeutics
- 28 Oct 2018 Results presented in an Esperion Therapeutics media release.
- 28 Oct 2018 According to an Esperion Therapeutics media release, based on the data from this study, company plans to submit NDA for an LDL-C lowering indication for the bempedoic acid / ezetimibe combination by the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) during the second quarter of 2019.
- 28 Oct 2018 According to an Esperion Therapeutics media release, the company has announced the completion of this Phase 3 LDL-C Lowering Development Program of bempedoic acid.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History