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A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

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Trial Profile

A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Alirocumab (Primary) ; Ezetimibe; Rosuvastatin
  • Indications Atherosclerosis; Cardiovascular disorders; Hypercholesterolaemia; Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY-OPTIONS-II; OPTIONS II
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 05 Sep 2018 Results of pooled data from 14 trials, were published in the Diabetic Medicine.
    • 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
    • 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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