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NCT00203476 · ClinicalTrials.gov registry record · Phase 4
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
A Phase 4 study, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00203476 is a Phase 4 study that has completed, run by Tuscaloosa Research & Education Advancement Corporation. The registered enrollment target is 30 participants.
The verdict
NCT00203476, a Phase 4 study, has completed, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
Interventions
- DRUG Niacin
- DRUG Ezetimibe
- DRUG Colestipol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00203476
The ClinicalTrials.gov registry entry for NCT00203476 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tuscaloosa Research & Education Advancement Corporation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Niacin is the first listed.
NCT00203476 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00203476 about?
NCT00203476 is a clinical study titled "A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction". To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult...
What is the current status of trial NCT00203476?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2005-05. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00203476?
The interventions under investigation include: Niacin (DRUG), Ezetimibe (DRUG), Colestipol (DRUG).
Who is sponsoring clinical trial NCT00203476?
This trial is sponsored by Tuscaloosa Research & Education Advancement Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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