A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

Trial Profile

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2017

At a glance

  • Drugs Alirocumab (Primary) ; Ezetimibe
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY-Combo-II
  • 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 of 3 phase III ODYSSEY trials (COMBO I, COMBO II and LONG TERM) 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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