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Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

NCT00145574 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2010-04-15

Study results available
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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.

Conditions

Interventions

DRUG

colesevelam HCl

Tablets

DRUG

placebo

Matching Tablets

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00145574 on ClinicalTrials.gov