Trials / Completed
CompletedNCT00145574
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Colesevelam HCl Administered to Pediatric Patients With Heterozygous Familial Hypercholesterolemia on a Stable Dose of Statins or Treatment Naive to Lipid-lowering Therapy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | colesevelam HCl | Tablets |
| DRUG | placebo | Matching Tablets |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2005-09-05
- Last updated
- 2010-04-15
- Results posted
- 2010-01-26
Locations
25 sites across 8 countries: United States, Australia, Austria, Canada, Israel, Netherlands, Norway, South Africa
Source: ClinicalTrials.gov record NCT00145574. Inclusion in this directory is not an endorsement.