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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Alirocumab (Primary) ; Atorvastatin; Ezetimibe; Rosuvastatin
  • Indications Atherosclerosis; Cardiovascular disorders; Hypercholesterolaemia; Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY OPTIONS I
  • 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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