MARS - Monitored Atherosclerosis Regression Study

Completed · Phase 2/Phase 3

Conditions studied: Atherosclerosis, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00116870

Run by

Merck Sharp & Dohme LLC

People needed

270

Starts

1985-06-01

Expected to finish

1992-02-01

Last updated by the study team

2009-12-11

Who can join

Age: 21 and older, up to 67. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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