Who is sponsoring NCT00145574?

NCT00145574 is sponsored by Daiichi Sankyo.

What condition does NCT00145574 study?

NCT00145574 studies Hypercholesterolemia.

What drugs are being tested in NCT00145574?

Interventions: colesevelam HCl, placebo.

What is the status of NCT00145574?

NCT00145574 is currently COMPLETED.

Last reviewed 2010-04-08 · How we verify

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

NCT00145574 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Daiichi Sankyo
Phase	Phase 4
Status	COMPLETED
Enrolment	194
Start date	2005-11
Completion	2007-12

Conditions

Hypercholesterolemia

Interventions

colesevelam HCl
placebo

Primary outcomes

Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. — 8 weeks (week 8 - day 1)
Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Countries

United States, Australia, Austria, Canada, Israel, Netherlands, Norway, South Africa