A Multicenter, Randomized, Double-Blind, Titration Study to

INTERVENTION: Trade Name: EZETROL Pharmaceutical Form: Tablet INN or Proposed INN: ezetimibe Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: CRESTOR Pharmaceutical Form: Tablet INN or Proposed INN: Rosuvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: CRESTOR Pharmaceutical Form: Tablet INN or Proposed INN: Rosuvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: hypercholesterolemia ; MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia PRIMARY OUTCOME: Main Objective: To evaluate the LDL‐C lowering efficacy of the addition of ezetimibe (10 mg) to rosuvastatin (5 or 10 mg) (pooled across doses) compared with doubling the baseline dose of rosuvastatin (pooled) in patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin (5 or 10 mg) alone and not at their NCEP ATP III LDL‐C goal. Primary end point(s): • Percent change from baseline in LDL‐C Secondary Objective: To evaluate the LDL‐C lowering efficacy of the addition of ezetimibe (10 mg) to the rosuvastatin 5 mg compared with rosuvastatin 10 mg in patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin 5 mg alone and not at their NCEP ATP III LDL‐C goal. 2. To evaluate the LDL‐C lowering efficacy of the addition of ezetimibe (10 mg) to rosuvastatin 10 mg compared with rosuvastatin 20 mg in patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin 10 mg alone and not at their NCEP ATP III LDL‐C goal. 3. In patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin 5 or 10 mg alone and not at their NCEP ATP III LDL‐C goal:; INCLUSION CRITERIA: • Men and women between 18 and 79 years of age. • Patient is currently taking a stable dose of lipid‐lowering agents listed below and the LDL‐C prescreen value is within the range noted in Appendix 6.8. Simvastatin 5 mg, 10 mg, 20 mg, 40 mg, 80 mg* Atorvastatin 10 mg, 20 mg, 40 mg* Rosuvastatin 5 mg, 10 mg Pravastatin 10 mg, 20 mg, 40 mg Fluvastatin 20 mg, 40 mg, 80 mg Lovastatin 10 mg, 20 mg, 40 mg, 80 mg Ezetimibe 10 mg Ezetimibe 10 mg + Pravastatin 10 mg Ezetimibe 10 mg + Simvastatin 10 mg* Ezetimibe + Fluvastatin 10 /20 mg or 10/40 mg Ezetimibe + Lovastatin 10/10 mg or 10/20 mg • Patient is moderately high risk (patients with multiple (2+) risk factors that confer a 10‐year risk for CHD of 10 to 20% as estimated from Framingham risk scores): Visit 2 LDL‐C =100 mg/dL but =160 mg/dL (2.6 and 4.2 mmol/L) ‐or‐ Patient is high risk without atherosclerotic vascular disease (patients with CHD risk equivalents: dia