Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe

Inclusion criteria

• Aged over 19 years
• Signed informed consent form
• At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL

Exclusion criteria

• At visit 1, BMI ≥ 30kg/㎡
• Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
• Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome
• Creatine Kinase > 5 x upper limit of normal
• ALT or AST > 3 x upper limit of normal
• Has a activity/chronic hepatic disease or HIV-positive
• Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein

• Uncontrolled diabetes mellitus(HbA1c ≥9%)
• Hypothyroidism (TSH > 1.5 x upper limit of normal rate at the screening )
• Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
• Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening)
• Severe heart failure (NYHA Class III or IV)
• Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
• History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
• Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
• Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
• Pregnant or breast-feeding
• Patients who have a drug or alcohol abuse or are being treated for psychological disorder
• Patients who were treated with other investigational drug within 12 weeks prior to screening
• Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs