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: 15 Nov 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

    • 15 Nov 2017 Results of pooled analysis from ten ODYSSEY trials assessing characteristics of patients with less than 5% LDL-C reduction presented at the 90th Annual Scientific Sessions of the American Heart Association
    • 15 Nov 2017 Results of post-hoc analysis examined impact of age on efficacy and safety of ALI in patients with HeFH, using pooled data from four 78-week ODYSSEY Phase 3 trials (FH I,FH II ,HIGH FH and LONG TERM), were presented at the 90th Annual Scientific Sessions of the American Heart Association.
    • 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.
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