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.
Phase of Trial: Phase IV
Latest Information Update: 03 Oct 2017
At a glance
- Drugs Colesevelam (Primary)
- Indications Hyperlipoproteinaemia type II
- Focus Registrational; Therapeutic Use
- Sponsors Daiichi Sankyo Inc
- 31 Aug 2018 Biomarkers information updated
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History