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A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Three Doses of SAR236553 (REGN727) Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol greater than or equal to 100 mg/dL (greater than or equal to 2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy

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Trial Profile

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Three Doses of SAR236553 (REGN727) Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol greater than or equal to 100 mg/dL (greater than or equal to 2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Alirocumab (Primary) ; Atorvastatin
  • Indications Hypercholesterolaemia
  • Focus Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 05 Sep 2018 Results of pooled data from 14 trials, were published in the Diabetic Medicine.
    • 07 Feb 2017 Pooled analysis (n=5234) of 14 trials assessing safety of very low low-density lipoprotein cholesterol levels with alirocumab, published in the Journal of the American College of Cardiology
    • 06 Jan 2017 Results of a pooled target mediated drug disposition population pharmacokinetics analysis of Alirocumab from this and 12 other studies (n=2870), published in the Clinical Pharmacokinetics.
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