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Randomized, double-blind, placebo-controlled efficacy and safety study of colesevelam HCl administered to pediatric patients with heterozygous familial hypercholesterolemia on a stable dose of statins [HMG CoA reductase inhibitors] or treatment naive to lipid-lowering therapy.

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Trial Profile

Randomized, double-blind, placebo-controlled efficacy and safety study of colesevelam HCl administered to pediatric patients with heterozygous familial hypercholesterolemia on a stable dose of statins [HMG CoA reductase inhibitors] or treatment naive to lipid-lowering therapy.

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Colesevelam (Primary)
  • Indications Hyperlipoproteinaemia type II
  • Focus Registrational; Therapeutic Use
  • Sponsors Daiichi Sankyo Inc

    • Most Recent Events

    • 01 Feb 2010 Results have been published (Journal of Pediatrics 156: 231-236, No. 2, Feb 2010).
    • 07 Oct 2009 The US FDA has approved colesevelam for the treatment of heterozygous familial hypercholesterolaemia in boys and postmenarchal girls based on the results of this trial, according to a Daiichi Sankyo media release.
    • 08 Nov 2008 Results presented at the 81st Annual Scientific Sessions of the American Heart Association.

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