Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy

To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.

Inclusion Criteria:

• Greater than 18 years of age
• Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
• Existing coronary heart disease and cholesterol > 4.0 mmol/l

Exclusion Criteria:

• Uncontrolled diabetes
• Elevated liver function tests
• Elevated creatine kinase (ck)
• Triglycerides (tg) > 4.5 mmol/l
• Drug or alcohol dependency within 6 months prior to visit 1
• Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
• Woman of childbearing potential not using an acceptable method of birth control
• Women who are pregnant or breast feeding