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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Undergoing Lipid Apheresis Therapy

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Undergoing Lipid Apheresis Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Alirocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY ESCAPE
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 12 Sep 2018 According to a Sanofi media release, the FDA approved an update to the Praluent Prescribing Information to include clinical information regarding its use in patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C (low-density lipoprotein cholesterol) along with diet and maximally-tolerated statin therapy and who are undergoing apheresis treatment. The update is supported by data from the pivotal Phase 3 ODYSSEY ESCAPE trial.
    • 15 Nov 2017 Results presented at the 90th Annual Scientific Sessions of the American Heart Association
    • 07 Nov 2017 According to a Regeneron Pharmaceuticals media release, data from the study will be presented at the American Heart Association (AHA) Scientific Sessions 2017.

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