MARS - Monitored Atherosclerosis Regression Study

• Status: Completed
• Trial end date: 1992-02-01
• Target enrollment: 0
• Participant gender: All

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 regression.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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