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A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2024

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At a glance

  • Drugs Alirocumab (Primary) ; Atorvastatin; Colestyramine; Ezetimibe; Fenofibrate; Fluvastatin; Lovastatin; Niacin; Nicotinic acids; Omega-3-fatty-acid; Pravastatin; Rosuvastatin; Simvastatin
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Sponsors Sanofi

    • Most Recent Events

    • 11 Mar 2024 According to a Regeneron Pharmaceuticals media release, company announced the U.S. Food & Drug Administration has extended the approval of alirocumab as an adjunct to diet and other low-density lipoprotein cholesterol lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia. The approval is based on results from this study.
    • 05 Feb 2024 Primary endpoint (DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24: Intent-to-treat (ITT) Estimand) has been met, as per results published in the Journal of the American Medical Association Pediatrics.
    • 05 Feb 2024 Results assessing the efficacy of alirocumab in pediatric patients with inadequately controlled HeFH, published in the Journal of the American Medical Association Pediatrics.
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