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NCT00283335 · ClinicalTrials.gov registry record · Phase 3
The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,531
- Enrollment target
NCT00283335: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT00283335 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 2,531 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00283335, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,531 participants
- Enrollment target
Study Summary
This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140 mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years. There was a risk reduction of 22% in the primary outcome (p=.0006) and 24% risk reduction in the combined endpoint of stroke, MI, and CHD death. The rate of events was reduced by raising HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med 1999;341:410-418).
Interventions
- OTHER Placebo
- DRUG gemfibrozil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,531 participants |
| Start Date | 1991-06 |
| Est. Completion | 1999-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00283335
The ClinicalTrials.gov registry entry for NCT00283335 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,531 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00283335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00283335 about?
NCT00283335 is a clinical study titled "The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol". This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140 mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal myocardial infarction(MI) or dea...
What is the current status of trial NCT00283335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,531 participants. The study started on 1991-06. Estimated completion is 1999-08.
What interventions are being tested in trial NCT00283335?
The interventions under investigation include: Placebo (OTHER), gemfibrozil (DRUG).
Who is sponsoring clinical trial NCT00283335?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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