STUDY OF PITAVASTATIN 4 MG vs. SIMVASTATIN 40 MG (FOLLOWING UP- TITRATION) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA AND 2 OR MORE RISK FACTORS FOR CORONARY HEART DISEASE

INTERVENTION: Trade Name: Livalo Tab Product Name: Pitavastatin Product Code: NK‐104 Pharmaceutical Form: Tablet INN or Proposed INN: Pitavastatin CAS Number: 147526‐32‐7 Current Sponsor code: NK‐104 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Livalo Tab Product Name: Pitavastatin Product Code: NK‐104 Pharmaceutical Form: Tablet INN or Proposed INN: Pitavastatin CAS Number: 147526‐32‐7 Current Sponsor code: NK‐104 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Zocord Product Name: Simvastatin Pharmaceutical Form: Capsule* INN or Proposed INN: Simvastatin CAS Number: 79902‐63‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Zocord Product Name: Simvastatin Pharmaceutical Form: Capsule* INN or Proposed INN: Simvastatin CAS Number: 79902‐63‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Hypercholesterolemia or Combined Dyslipidemia and 2 or more risk factors for coronary heart disease (CHD) ; MedDRA version: 7.1 Level: LLT Classification code 10020604 PRIMARY OUTCOME: Main Objective: To demonstrate the non‐inferiority of pitavastatin 4 mg once daily (QD) versus (vs.) simvastatin 40 mg QD, with respect to the reduction of LDL‐C, when administered for 12 weeks using an up‐titration regimen. Primary end point(s): To demonstrate the non‐inferiority of pitavastatin 4 mg once daily (QD) versus (vs.) simvastatin 40 mg QD. Secondary Objective: To compare the efficacy of pitavastatin 4 mg QD vs. simvastatin 40 mg QD with respect to changes from baseline in other lipid and lipoprotein fractions (TC, HDL C, TC:HDL‐C ratio, non‐HDL:HDL ratio, TG, apolipoprotein B [Apo B] and apolipoprotein A1 [Apo‐A1], , Apo‐B:Apo‐A1 ratio, high sensitivity C‐reactive protein [hs‐CRP], oxidized LDL, and LDL‐C target attainment [European Atherosclerosis Society {EAS} and National Cholesterol Education Program {NCEP}]); ; To assess the safety and tolerability of pitavastatin 4 mg QD when administered for 12 weeks using an up‐titration regimen. INCLUSION CRITERIA: 1. Males and females (age range 18‐75 years); 2. Non‐pregnant, non‐lactating females. Women of child bearing potential are allowed to enter the study ONLY if they use sustained contraceptive preparations (e.g., implants or intramuscular [IM] injections) or comply with an approved mechanical contraceptive method. 3. At least two cardiovascular disease risk factors have to be present: ‐ Cigarette smoking; ‐ Hypertension (blood pressure =140/90 mm Hg or on antihypertensive medication); ‐ Low HDL‐C (<1.0 mmol/L [40 mg/dL]); ‐ Family history of premature (CHD in male first‐degree relative <55 years of age; CHD in female first‐degree relative <65 years of age) Note: If HDL‐C is >60 mg/dL at Visit 3 (Week ‐1) or Visit 3A (if applicable) then the number of risk factors will be reduced by 1. ‐ Age (men =45 years, women =55 years). 4. Patients who are eligible and able to participate in the study and who have given informed consent a