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A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

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Trial Profile

A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2025

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At a glance

  • Drugs Bempedoic acid (Primary)
  • Indications Dyslipidaemias; Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical

    • Most Recent Events

    • 26 Nov 2024 According to an Esperion Therapeutics media release, company announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid in Japan for the treatment of hypercholesterolemia and familial hypercholesterolemia based on this phase 3 trial.
    • 12 Aug 2024 According to an Esperion media release, company plans to file a New Drug Application (NDA) in Japan in the second half of 2024, with expected approval and National Health Insurance (NHI) pricing anticipated in 2025.
    • 09 Apr 2024 Status changed from active, no longer recruiting to completed.

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