Status:
COMPLETED
MARS - Monitored Atherosclerosis Regression Study
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Atherosclerosis
Coronary Artery Disease
Eligibility:
All Genders
21-67 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether significant alterations in serum lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis progression or even induce r...
Detailed Description
Two conceptual advances occurring in the 1980's made it possible to test the hypothesis that significant alterations in serum lipoproteins can substantially reduce atherosclerosis progression or even ...
Eligibility Criteria
Inclusion
- Angiography within 17 weeks of randomization showing patient is at high risk for coronary artery disease but not a candidate for coronary artery graft surgery
- Men and women ages 21 through 67 years
- Mean plasma cholesterol levels from the first two screening visits in the range of 190 to 270 mg/dL
- Smokers are admitted, but encouraged to stop smoking tobacco
Exclusion
- Premenopausal women unless surgically sterilized
- Hypertension, diabetes, thyroid disease, liver dysfunction, renal insufficiency, congestive heart failure, major arrhythmia, left ventricular conduction defects
- Physical impairment that may interfere with participation
- Life threatening disease with high likelihood of disability or death during the trial period
- Use of hydralazine, guanethidine, lipid-lowering drugs, estrogens, steroids, amphetamines, antibiotics, theophylline, acetaminophen (average daily use greater than ten grains), other drugs as determined by the principle investigator
- Vitamins A or D in doses greater than the Recommended Daily Allowance (RDA)
- Alcohol abuse
- Nutritional supplements high in cholesterol content
- Chelation therapy
- Psychosocial situations which make completion of the study unlikely
- Hypersensitivity to any component of the study medication
Key Trial Info
Start Date :
June 1 1985
Trial Type :
INTERVENTIONAL
End Date :
February 1 1992
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00116870
Start Date
June 1 1985
End Date
February 1 1992
Last Update
December 11 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033