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.

Official Title

A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

Conditions

Hypercholesterolemia, Metabolic Syndrome

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Change in LDL-C

Secondary Outcome Measures:

  • Change in other lipid parameters

Study Start

December 2006

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years – 79 Years
  • Genders Eligible for Study: Both

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)

Total Enrolment

1120

Contact Details

Merck Sharp & Dohme (Australia) Inc., South Granville, NSW 2142, Australia; Recruiting

  • David Woolner: 61-2-9795-9500