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NCT00397657 · ClinicalTrials.gov registry record · Phase 4
Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis
A Phase 4 study, sponsored by Walter Reed Army Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
NCT00397657 is a Phase 4 study that was terminated before completion, run by Walter Reed Army Medical Center. The registered enrollment target is 400 participants.
The verdict
NCT00397657, a Phase 4 study, was terminated before completion, sponsored by Walter Reed Army Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
Study Summary
Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid disorders (NCEP ATPIII) were revised to indicate that an LDL-C treatment goal of 70 mg/dL (revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines, low levels of high-density lipoprotein (HDL-C) are also suggested but not specifically proscribed as a target of therapy. Recently the ARBITER 2 trial has provided the first evidence of the potential of raising HDL-C with extended release niacin when added to statin monotherapy. However, whether this approach would be superior to a strategy in which lower concentrations of LDL-C are targeted is unknown. The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid treatments for their effects of atherosclerosis. This study is a prospective, randomized, open-label, blinded endpoint trial comparing treatment strategies of either HDL-raising therapies or LDL reduction for dyslipidemia on carotid atherosclerosis. Subjects with known atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through the presence of a coronary risk equivalent who are currently being treated with a statin will be eligible. Subjects will be randomly assigned in an allocation-concealed fashion to open label treatment with either Ezetimibe 10 mg/d for additional LDL-lowering OR Extended-release niacin (1 gm/d, titrated to max tolerable dose up to 2 gm/d) for HDL improvement. The effects of these 2 different strategies of intensified lipid management on atherosclerosis will be assessed by the change in the carotid intima-media thickness, a validated surrogate endpoint. The data will help guide clinicians on the potential benefits of these lipid treatment strategies.
Interventions
- DRUG ezetimibe
- DRUG extended release niacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00397657
The ClinicalTrials.gov registry entry for NCT00397657 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed Army Medical Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ezetimibe is the first listed.
NCT00397657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00397657 about?
NCT00397657 is a clinical study titled "Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis". Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid disorders (NCEP ATPIII) were ...
What is the current status of trial NCT00397657?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2006-11. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00397657?
The interventions under investigation include: ezetimibe (DRUG), extended release niacin (DRUG).
Who is sponsoring clinical trial NCT00397657?
This trial is sponsored by Walter Reed Army Medical Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
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