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A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy

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; Hyperlipidaemia; Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Registrational
  • Acronyms CLEAR Harmony
  • 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.
    • 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.
    • 16 Dec 2020 According to a Daiichi Sankyo Company media release, NILEMDO (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI (bempedoic acid and ezetimibe) tablet has been approved in Switzerland by the Swissmedic for the treatment of people with high low-density lipoprotein cholesterol (LDL-C). Both approvals were supported by data from the CLEAR trial program, which included more than 3,600 high- and very-high-risk patients.
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