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A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Alirocumab in Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Alirocumab in Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Sep 2016

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At a glance

  • Drugs Alirocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY JAPAN
  • Sponsors Sanofi
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 05 Jul 2016 Results published in Regeneron media release.
    • 05 Jul 2016 According to Regeneron media release, the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Praluent (alirocumab) for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk.
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