Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
NCT ID: NCT00145574
Last Updated: 2010-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
194 participants
INTERVENTIONAL
2005-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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high dose colesevelam
colesevelam HCl 3.750 g
colesevelam HCl
Tablets
Low dose colesevelam
Low dose colesevelam 1.875 g
colesevelam HCl
Tablets
placebo
placebo comparator
placebo
Matching Tablets
Interventions
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colesevelam HCl
Tablets
placebo
Matching Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
10 Years
17 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo
Locations
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Washington D.C., District of Columbia, United States
St Louis, Missouri, United States
New Hyde Park, New York, United States
New York, New York, United States
The Bronx, New York, United States
Cincinnati, Ohio, United States
Wexford, Pennsylvania, United States
Salt Lake City, Utah, United States
Camperdown NSW, , Australia
Vienna, , Austria
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Laval, Quebec, Canada
Stefoy, Quebec, Canada
Holon, , Israel
Jerusalem, , Israel
Kefer Saba, , Israel
Tel Litwinsky, , Israel
Amsterdam, , Netherlands
Rotterdam, , Netherlands
Oslo, , Norway
Observatory, , South Africa
Pretoria, , South Africa
Tygerberg, , South Africa
Countries
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References
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Stein EA, Marais AD, Szamosi T, Raal FJ, Schurr D, Urbina EM, Hopkins PN, Karki S, Xu J, Misir S, Melino M. Colesevelam hydrochloride: efficacy and safety in pediatric subjects with heterozygous familial hypercholesterolemia. J Pediatr. 2010 Feb;156(2):231-6.e1-3. doi: 10.1016/j.jpeds.2009.08.037. Epub 2009 Oct 31.
Other Identifiers
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WEL-410
Identifier Type: -
Identifier Source: org_study_id
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