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

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2017

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

    • 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.
    • 02 Nov 2017 Results of pooled efficacy analysis (3 pools: alirocumab 150 mg (Q2W) vs placebo; alirocumab (75 mg Q2W with possible dose increase to 150 mg Q2W at Week 12 based on Week 8 LDL-C) vs placebo; alirocumab 75/150 mg Q2W vs ezetimibe) of this and other 7 trials presented at the 29th Annual Scientific Symposium on Transcatheter Cardiovascular Therapeutics
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