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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2022

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At a glance

  • Drugs Alirocumab (Primary) ; HMG-CoA reductase inhibitors
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY-CHOICE-I
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 05 Jun 2019 Results evaluating efficacy and safety of Alirocumab published in the Journal of Clinical Endocrinology and Metabolism
    • 25 Apr 2017 According to a Regeneron and Sanofi media release, based on the data from this trial, U.S. FDA approved supplemental Biologics License Application for a once-monthly (every four weeks), 300 mg dose of Praluent (alirocumab) Injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol. European Commission (EC) also approved the monthly 300 mg dose of Praluent in November 2016.
    • 16 Nov 2016 Results (n=299) of a pharmacodynamic analysis presented at the 89th Annual Scientific Sessions of the American Heart Association.

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