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A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG

Trial Profile

A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Bempedoic acid (Primary)
  • Indications Hypercholesterolaemia
  • Focus Adverse reactions
  • Acronyms CLEAR Harmony OLE
  • Sponsors Esperion Therapeutics
  • Most Recent Events

    • 06 Nov 2019 According to an Esperion Therapeutics media release, a presentation and poster of pooled analyses from the Phase 3 LDL-C lowering development program of bempedoic acid will be presented at the American Heart Association Scientific Sessions in Philadelphia.
    • 07 Jan 2019 According to a Daiichi Sankyo Europe media release, the company plans to submit New Drug Applications (NDAs) to the Food and Drug Administration (FDA) during the first quarter of 2019 and Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) during the second quarter of 2019. FDA and EMA LDL-C approval decisions are expected during the first half of 2020.
    • 31 Aug 2018 Biomarkers information updated
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