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

Organon and Co1,143 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,143

Conditions

Hypercholesterolemia Metabolic Syndrome

Interventions

ezetimibe (+) simvastatinDRUG

Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.

Comparator: atorvastatin calciumDRUG

Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Comparator: Placebo (unspecified)DRUG

Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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)