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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2024

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At a glance

  • Drugs Bempedoic acid (Primary)
  • Indications Cardiovascular disorders; Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR Outcomes; CVOT
  • Sponsors Esperion Therapeutics
  • Most Recent Events

    • 22 Mar 2024 According to an Esperion Therapeutics media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination (FDC),recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.,Based On The Analyses Of The Phase 3 Of The CLEAR Outcomes Trial.
    • 22 Mar 2024 According to an Esperion AB media release, the Company's pending label expansions in Europe remain on track, with a positive opinion received from the Committee for Medicinal Products for Human Use (CHMP) on March 21, 2024. The Company anticipates a final determination by the European Medicines Agency in the second quarter of 2024.
    • 22 Mar 2024 According to an Esperion AB media release, company announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data.
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