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The VA HDL Intervention Trial

This study has been completed.
Sponsor:
Collaborators:
Parke-Davis
Fournier Labs
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00283335
First received: January 25, 2006
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Coronary Heart Disease
 Drug: gemfibrozil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: CSP #363 - The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol

Resource links provided by NLM:

Drug Information available for: Gemfibrozil
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 2561
Study Start Date: June 1991

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 73 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria:

  1. male gender
  2. age 73 or younger
  3. presence of CHD
  4. HDL-C le 40 mg/dl
  5. LDL-C le 140 mg/dl
  6. triglycerides le 300 mg/dl

Exclusion criteria:

  1. significant medical illness
  2. alcohol or substance abuse
  3. evidence of cholecystitis or cholelithiasis
  4. ejection fraction of lt 35%
  5. current use of steroids, estrogens, immunosuppressive agents, oral coagulants, or lipid modifying drug.
  6. allergic to gemfibrozil or fibric acid
  7. refused informed consent

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283335

Locations
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Department of Veterans Affairs
Parke-Davis
Fournier Labs
Investigators
Study Chair: Hanna E. Bloomfield, MD MPH Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Bloomfield, Hanna - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00283335     History of Changes
Other Study ID Numbers: 363
Study First Received: January 25, 2006
Last Updated: June 10, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013