CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 194 enrolled
Drug / intervention
colesevelam HCl +1 moredrug
Likely dose
Colesevelam HCl tablets (specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓Ages 10 to 17 years inclusive
  • ✓Diagnosis of heterozygous familial hypercholesterolemia
  • ✓On a stable dose of statin monotherapy or treatment-naive to lipid-lowering agents
  • ✓On a low-cholesterol diet
Key exclusion· 1
  • ✕Serious concomitant conditions that could interfere with analysis of results or well-being of the patient

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00145574
NCT00145574Phase 4Completed
CompareCT.gov

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 or Treatment Naive to Lipid-lowering Therapy

Daiichi Sankyo·interventional·Posted Sep 5, 2005·Updated Apr 15, 2010

In Brief

A Phase 4 clinical trial evaluating colesevelam HCl and placebo for Hypercholesterolemia. Completed, enrolled 194 participants across 25 sites in 8 countries.

Detailed Summary

This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia, Austria, Canada, Israel, Netherlands, Norway, South Africa, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.8 years ago

Interventions

colesevelam HCldrug

Tablets

placebodrug

Matching Tablets