Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium; Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

Inclusion Criteria:

• Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion Criteria:

• A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study

• Patient is likely to be greater than 20% noncompliant in taking study medications

• Patients with chronic medical conditions

• Patients with unstable doses of medications

• Pregnant or lactating women, women intending to become pregnant

• Patient is currently receiving prescription therapy with statins or other lipid-altering medications

• Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)