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

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