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The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol

NCT00283335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2531

Last updated 2015-10-21

No results posted yet for this 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).

Conditions

Interventions

DRUG

gemfibrozil

OTHER

Placebo

Matching placebo tablets taken once per day

Sponsors & Collaborators

  • Parke-Davis

    collaborator INDUSTRY

  • Fournier Labs

    collaborator UNKNOWN

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Hanna E. Bloomfield, MD MPH · Minneapolis VA Health Care System, Minneapolis, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
73 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-06-30
Primary Completion
1998-09-30
Completion
1999-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00283335 on ClinicalTrials.gov