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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy

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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Alirocumab (Primary) ; HMG-CoA reductase inhibitors
  • Indications Atherosclerosis; Cardiovascular disorders; Hypercholesterolaemia; Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY-High-FH
  • Sponsors Sanofi

    • Most Recent Events

    • 05 Sep 2018 Results of pooled data from 14 trials, were published in the Diabetic Medicine.
    • 01 Jun 2018 Results of a pooled analysis of 5 studies (LONG TERM, HIGH FH, FH I, FH II and COMBO) assessing the safety and efficacy of Alirocumab, published in the Diabetes Therapy
    • 02 Feb 2018 Results (n=3499) of pooled analysis assessing efficacy and safety from FH I,FH II, LONG TERM, HIGH FH, COMBO I studies, published in the American Journal of Cardiology.

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