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NCT00145574 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
A Phase 4 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 4
- Development phase
- 194
- Enrollment target
NCT00145574: Completed Phase 4 study, sponsored by Daiichi Sankyo.
NCT00145574 is a Phase 4 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 194 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00145574, a Phase 4 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 194 participants
- Enrollment target
Study 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.
Primary Outcome
Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.
Interventions
- DRUG placebo
- DRUG colesevelam HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2005-11 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00145574 record still lists
NCT00145574 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00145574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00145574 about?
NCT00145574 is a clinical study titled "Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol". 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 ...
What is the current status of trial NCT00145574?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 194 participants. The study started on 2005-11. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00145574?
The interventions under investigation include: placebo (DRUG), colesevelam HCl (DRUG).
Who is sponsoring clinical trial NCT00145574?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00145574's enrollment target sits among peer trials
194 451st of 2000 higher than 1,550 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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