A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)

Inclusion criteria

• 19 ~ 79 years old
• Patients who confirmed hypercholesterolemia.
• Patients who requiring drug therapy according to NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Visit2.
• Patients with Triglyceride< 400 at Visit 2.
• Patients who have a wash-out period over 4 weeks for other drugs that can affect lipid profile.(Patients who have lipid regulators should have washout period over six weeks)
• Patients who agreed to participate in the trial

Exclusion criteria

• Patients who have a history of myopathy or rhabdomyolysis by statin treatment or hypersensitivity to statin HMG CoA(3-hydroxy-3-methylglutaryl-coenzyme) reductase inhibitors) or ezetimibe.
• A heavy alcohol consumer. (alcohol > 25 units/week)
• Patients with severe renal disease. (creatinine ≥ 2.0 mg/dL)
• Patients with active liver disease and AST(aspartate transaminase) or ALT(alanine transaminase) > 2 times of upper limit of normal range.
• Patients with CPK(creatine phosphokinase) > 2 x upper limit of normal range.
• Patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein.
• Patients with HIV(human immunodeficiency virus positive.
• Patients who have a acute arteriopathy.
• Patients with uncontrolled hypertension.
• Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder.
• Patients with tumor.
• Patients who have hormonal therapy.
• Pregnancy or breastfeeding patients who don't agree to use adequate contraception.
• Patients who are judged unsuitable to participate in this study by investigator.
• Patients taking other clinical trial drugs within 30 days from the time of visit for screening.