MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162 AM2)

• Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 10 mg versus atorvastatin 20 mg [ Time Frame: Baseline (Phase I) and Week 6 (End of 6 Week Phase I Treatment Period) ] [ Designated as safety issue: No ]
• Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 10 mg versus rosuvastatin 10 mg [ Time Frame: Baseline (Phase I) and Week 6 (End of 6 Week Phase I Treatment Period) ] [ Designated as safety issue: No ]

• Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 20 mg versus atorvastatin 40 mg [ Time Frame: Week 6 (Baseline for Phase II) and Week 12 (End of 6 Week Phase II Treatment Period) ] [ Designated as safety issue: No ]
• Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 20 mg versus rosuvastatin 20 mg [ Time Frame: Week 6 (Baseline for Phase II) and Week 12 (End of 6 Week Phase II Treatment Period) ] [ Designated as safety issue: No ]

This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels.

• Drug: ezetimibe (+) atorvastatin
  Phase I: ezetimibe 10 mg and atorvastatin 10 mg once daily for 6 weeks
• Drug: Comparator: ezetimibe (+) atorvastatin
  Phase I: ezetimibe 10 mg and atorvastatin 10 mg once daily for 6 weeks; Patients completing Phase I will continue to Phase II: ezetimibe 10 mg and atorvastatin 10 mg for six weeks
• Drug: Comparator: atorvastatin, switching to ezetimibe (+) atorvastatin
  Phase I: atorvastatin 20 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: ezetimibe 10 mg and atorvastatin 20 mg for six weeks
• Drug: Comparator: atorvastatin
  Phase I: atorvastatin 20 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: atorvastatin 40 mg for six weeks
• Drug: Comparator: rosuvastatin, switching to ezetimibe (+) atorvastatin
  Phase I: rosuvastatin 10 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: ezetimibe 10 mg and atorvastatin 20 mg for six weeks
• Drug: Comparator: rosuvastatin
  Phase I: rosuvastatin 10 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: rosuvastatin 20 mg for six weeks

• Experimental: 1
  Phase I: ezetimibe 10 mg + atorvastatin 10 mg
  Intervention: Drug: ezetimibe (+) atorvastatin
• Experimental: 2
  Phase I: ezetimibe 10 mg + atorvastatin 10 mg; Phase II: ezetimibe 10 mg + atorvastatin 10 mg
  Intervention: Drug: Comparator: ezetimibe (+) atorvastatin
• Experimental: 3
  Phase I: atorvastatin 20 mg; Phase II: ezetimibe 10 mg + atorvastatin 20 mg
  Intervention: Drug: Comparator: atorvastatin, switching to ezetimibe (+) atorvastatin
• Active Comparator: 4
  Phase I: atorvastatin 20 mg; Phase II: atorvastatin 40 mg
  Intervention: Drug: Comparator: atorvastatin
• Experimental: 5
  Phase I: rosuvastatin 10 mg; Phase II: ezetimibe 10 mg + atorvastatin 20 mg
  Intervention: Drug: Comparator: rosuvastatin, switching to ezetimibe (+) atorvastatin
• Active Comparator: 6
  Phase I: rosuvastatin 10 mg; Phase II: rosuvastatin 20 mg
  Intervention: Drug: Comparator: rosuvastatin

Inclusion Criteria:

• Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
• Patient is willing to maintain a cholesterol lowering diet during the study
• Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study

Exclusion Criteria:

• Patient is Asian
• Patient routinely has more than 2 alcoholic drinks per day
• Female patient is pregnant or breastfeeding
• Patient has congestive heart failure
• Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
• Patient has uncontrolled cardiac arrhythmias
• Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
• Patient has uncontrolled high blood pressure
• Patient has kidney disease
• Patient has any disease known to influence blood lipid levels
• Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
• Patient has poorly controlled or newly diagnosed diabetes
• Patient is known to be HIV positive
• Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers