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

Inclusion criteria

• Adults aged 19 years or older
• Patients with primary hypercholesterolemia
• Patients who were informed about the purpose, method, effects, risks of this clinical study and have provided a written consent form signed by him/herself or by a representative
• those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350 mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the administration of antidyslipidemic drug of NCEP ATP III

Exclusion criteria

• Patients with hypersensitivity to the investigational product or its ingredients
• Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)
• Those with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebral vascular disease, coronary artery bypass or coronary intervention within 3 months of screening date
• Those with a history of malignant tumor within 5 years
• Those with a history of myopathy or rhabdomyolysis
• Those who show clinically significant confirmed laboratory test results (1) Patients showing AST or ALT level of greater than 2 times the institutional upper limit of normal or those with active liver disease or chronic hepatitis (2) A serum creatinine level greater than 2 times the institutional upper limit of normal (3) HbA1c > 9% (4) Those with TSH level of greater than 1.5 times the institutional upper limit of normal (5) Those with CK level greater than 2 times the institutional upper limit of normal (However, except for an increase caused by a recent trauma, intramuscular injection or strenuous exercise)
• Those who were given, within 4 weeks prior to the baseline (8 weeks in case of fibrate) or are expected to be given during the study period, a drug that can have an effect on the efficacy assessment of the clinical study (eg: antidyslipidemic drug (statins, ezetimibe, fibrates, BAS, nicotinic acid and derivative, etc.), systemic glucocorticosteroids, steatolytic enzyme inhibitor, cyclosporine, HIV proteinase inhibitor, macrolide class antibiotics, etc.)
• Patients who were given estrogen within 3 months from the screening or those who are expected to be given an administration during the study period. (However, a patient who is under a hormone replacement therapy (HRT) will be allowed if no dose change is expected in the course of the clinical study.)
• Those with a history of alcohol or drug abuse
• Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Pregnant or breast-feeding women
• Women of childbearing potential or men who do not intend to use an adequate contraceptive measure during the study period and for 4 weeks after the end of the study(Adequate contraception: Administration and transplantation of a progestin-only contraceptive pill, intrauterine device, condom, spermicidal agent, etc.)
• Patients who participated in another clinical study within 3 months from the screening date or have not had a washout period of at least 5 times the half-life of the active ingredient of the previously administered investigational product, whichever is longer
• Those with drug malabsorption
• Patients who has been judged by the investigator to be ineligible to participate in the clinical study