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NCT00753779 · ClinicalTrials.gov registry record · Phase 4
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
A Phase 4 study of Hypercholesterolemia, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
- 14
- Study locations
NCT00753779 is a Phase 4 study of Hypercholesterolemia that has completed, run by Daiichi Sankyo. The registered enrollment target is 72 participants, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (91% lower). The trial reports 14 study locations across 10 states.
The verdict
NCT00753779, a Phase 4 study of Hypercholesterolemia, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
- 14
- Study locations
Study Summary
The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
Conditions Studied
Interventions
- DRUG colesevelam HCl tablets, and simvastatin tablets
- DRUG simvastatin tablets and colesevelam HCl placebo
Study Locations (14)
Florida
- - Jacksonville
- - Pembroke Pines
- - St. Petersburg
Ohio
- - Cincinnati
- - Cleveland
Virginia
- - Norfolk
- - Richmond
California
- - Los Angeles
Colorado
- - Castle Rock
Illinois
- - Chicago
Indiana
- - Indianapolis
New York
- - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2002-11 |
| Est. Completion | 2005-04 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00753779
The ClinicalTrials.gov registry entry for NCT00753779 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (91% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which colesevelam HCl tablets, and simvastatin tablets is the first listed.
NCT00753779 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Florida, Ohio, Virginia.
Frequently Asked Questions
What is clinical trial NCT00753779 about?
NCT00753779 is a clinical study titled "A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.". The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
What is the current status of trial NCT00753779?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2002-11. Estimated completion is 2005-04.
What conditions does trial NCT00753779 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT00753779?
The interventions under investigation include: colesevelam HCl tablets, and simvastatin tablets (DRUG), simvastatin tablets and colesevelam HCl placebo (DRUG).
Who is sponsoring clinical trial NCT00753779?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00753779 being conducted?
This trial has 14 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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