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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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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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