Status:
COMPLETED
The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Parke-Davis
Fournier Labs
Conditions:
Coronary Heart Disease
Eligibility:
MALE
Up to 73 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Primary Hypothesis: To determine if drug treatment aimed at raising HDL-cholesterol and lowering triglycerides will reduce the rate of heart attack and death in veterans with coronary heart disease (...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- male gender
- age 73 or younger
- presence of CHD
- HDL-C le 40 mg/dl
- LDL-C le 140 mg/dl
- triglycerides le 300 mg/dl
Exclusion
- Exclusion criteria:
- significant medical illness
- alcohol or substance abuse
- evidence of cholecystitis or cholelithiasis
- ejection fraction of lt 35%
- current use of steroids, estrogens, immunosuppressive agents, oral coagulants, or lipid modifying drug.
- allergic to gemfibrozil or fibric acid
- refused informed consent
Key Trial Info
Start Date :
June 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1999
Estimated Enrollment :
2531 Patients enrolled
Trial Details
Trial ID
NCT00283335
Start Date
June 1 1991
End Date
August 1 1999
Last Update
October 21 2015
Active Locations (1)
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1
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417