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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia; Metabolic Syndrome

Treatments: Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409773

0653A-107

2006_527

Details and patient eligibility

About

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.

Enrollment: 1,143 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,143 participants in 5 patient groups

1

Other group

Description:

Arm 1: drug + comparator + Placebo

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: ezetimibe (+) simvastatin

Drug: Comparator: atorvastatin calcium

2

Other group

Description:

Arm 2: drug + comparator + Placebo

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: ezetimibe (+) simvastatin

Drug: Comparator: atorvastatin calcium

3

Other group

Description:

Arm 3: drug + comparator + Placebo

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: ezetimibe (+) simvastatin

Drug: Comparator: atorvastatin calcium

4

Other group

Description:

Arm 4: drug + comparator + Placebo

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: ezetimibe (+) simvastatin

Drug: Comparator: atorvastatin calcium

5

Other group

Description:

Arm 5: drug + comparator + Placebo

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: ezetimibe (+) simvastatin

Drug: Comparator: atorvastatin calcium