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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2017

At a glance

  • Drugs Alirocumab (Primary) ; HMG-CoA reductase inhibitors
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY-High-FH
  • Sponsors Sanofi
  • Most Recent Events

    • 11 Aug 2017 Results (n=3341) of a pooled post-hoc analysis from ten ODYSSEY Phase 3 (LONG TERM, HIGH FH, COMBO I, FH I, FH II, COMBO II, OPTIONS I, OPTIONS II, MONO and ALTERNATIVE) trials, published in the Diabetic Medicine.
    • 13 Jun 2017 Results of pooled analysis from ten ODYSSEY Phase 3 (LONG TERM, HIGH FH, COMBO I, FH I, FH II, COMBO II, OPTIONS I, OPTIONS II, MONO and ALTERNATIVE) trials presented at the 77th Annual Scientific Sessions of the American Diabetes Association
    • 10 Jun 2017 Biomarkers information updated
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