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

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00145574

Run by

Daiichi Sankyo

People needed

194

Starts

2005-11-01

Expected to finish

2007-12-01

Last updated by the study team

2010-04-15

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — St Louis, Missouri, United States
• Study site — New Hyde Park, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Wexford, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Camperdown NSW, Australia
• Study site — Vienna, Austria
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Chicoutimi, Quebec, Canada
• Study site — Laval, Quebec, Canada
• Study site — Stefoy, Quebec, Canada
• Study site — Holon, Israel
• Study site — Jerusalem, Israel
• Study site — Kefer Saba, Israel
• Study site — Tel Litwinsky, Israel
• Study site — Amsterdam, Netherlands
• Study site — Rotterdam, Netherlands
• Study site — Oslo, Norway
• Study site — Observatory, South Africa
• Study site — Pretoria, South Africa
• Study site — Tygerberg, South Africa

Full record on ClinicalTrials.gov

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