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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2019

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At a glance

  • Drugs Alirocumab (Primary) ; Atorvastatin; Rosuvastatin; Simvastatin
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY-FH-II
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 05 Sep 2018 Results of pooled data from 14 trials, were published in the Diabetic Medicine.
    • 31 Aug 2018 Biomarkers information updated
    • 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
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