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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC 1002) 180 mg/Day as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC 1002) 180 mg/Day as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2023

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At a glance

  • Drugs Bempedoic acid (Primary)
  • Indications Atherosclerosis; Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR Tranquility
  • Sponsors Esperion Therapeutics
  • Most Recent Events

    • 01 Nov 2023 Results assessing the effect of bempedoic acid in women and men using pooled, patient-level data from four phase 3 clinical trials of bempedoic acid (CLEAR Wisdom (NCT02991118), CLEAR Harmony (NCT02666664), CLEAR Tranquility (NCT03001076), and CLEAR Serenity (NCT02988115)) published in the Atherosclerosis.
    • 01 Aug 2023 According to an Esperion AB Media Release, the company announced the submission of its Supplemental New Drug Applications (sNDAs) for NEXLETOL and NEXLIZET to the Food and Drug Administration (FDA), and the submission of an application for expanded indication for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe) to the European Medicines Agency (EMA).
    • 18 Apr 2022 Results of post-hoc pooled analysis of four studiesCLEAR Tranquility; NCT03001076), (CLEAR Serenity; NCT02988115), (CLEAR Wisdom [NCT02991118] and CLEAR Harmony [NCT02666664]) assessing effect of bempedoic acid on glycaemic and lipid variables in patients with hypercholesterolaemia, published in the Diabetes, Obesity and Metabolism.
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