Status:
COMPLETED
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
10-17 years
Phase:
PHASE4
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00145574
Start Date
November 1 2005
End Date
December 1 2007
Last Update
April 15 2010
Active Locations (25)
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1
Washington D.C., District of Columbia, United States
2
St Louis, Missouri, United States
3
New Hyde Park, New York, United States
4
New York, New York, United States