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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride

Criteria

Inclusion Criteria:

• Male or female patients

• Ages 10 to 17 years inclusive

• Diagnosis of heterozygous familial hypercholesterolemia

• On a stable dose of statin monotherapy or are treatment naive to lipid- lowering agents

• On a low-cholesterol diet

Exclusion Criteria:

• Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients