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NCT00754039 · ClinicalTrials.gov registry record · Phase 4
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
A Phase 4 study of Hypercholesterolemia and Hyperlipidemia, Familial Combined, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 4
- Development phase
- 129
- Enrollment target
- 10
- Study locations
NCT00754039 is a Phase 4 study of Hypercholesterolemia and Hyperlipidemia, Familial Combined that has completed, run by Daiichi Sankyo. The registered enrollment target is 129 participants, below the 815-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (84% lower). The trial reports 10 study locations across 7 states.
The verdict
NCT00754039, a Phase 4 study of Hypercholesterolemia and Hyperlipidemia, Familial Combined, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 129 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
Conditions Studied
Interventions
- DRUG colesevelam HCl tablets and fenofibrate tablets
- DRUG fenofibrate tablets and Welchol placebo tablets
Study Locations (10)
Florida
- - Longwood
- - Ocala
- - Winterpark
Illinois
- - Chicago
- - Lombard
Kansas
- - Overland Park
North Carolina
- - Stateville
Ohio
- - Cincinnati
Texas
- - San Antonio
Virginia
- - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00754039
The ClinicalTrials.gov registry entry for NCT00754039 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 815-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (84% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which colesevelam HCl tablets and fenofibrate tablets is the first listed.
NCT00754039 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Florida, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT00754039 about?
NCT00754039 is a clinical study titled "Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol". The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
What is the current status of trial NCT00754039?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2003-02. Estimated completion is 2004-03.
What conditions does trial NCT00754039 study?
This clinical trial studies the following conditions: Hypercholesterolemia, Hyperlipidemia, Familial Combined.
What interventions are being tested in trial NCT00754039?
The interventions under investigation include: colesevelam HCl tablets and fenofibrate tablets (DRUG), fenofibrate tablets and Welchol placebo tablets (DRUG).
Who is sponsoring clinical trial NCT00754039?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00754039 being conducted?
This trial has 10 study locations across Florida, Illinois, Kansas, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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