Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

Inclusion Criteria:

1. Individuals aged between 19 and 80 years old.

2. The following patients who belong to the low-risk group to the very-high risk groupaccording to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ 2016).

• Very high risk group (coronary artery disease, ischemic stroke, peripheralvascular disease) were not receiving lipid-lowering agents (statins) within 4weeks of the screening, regardless of LDL-C levels

• High risk group (carotid artery disease, abnormal aneurysm, diabetes)* : LDL-C ≥ 100 mg/dl

• Moderate risk group (2 or more major risk factors)* : LDL-C ≥ 130 mg/dl

• Low risk group (less than 1 major risk factors)* : LDL-C ≥ 160 mg/dl

• If the patients taka a lipid-lowering agents (statin) within 4 weeks ofscreening, enrolled them after wash-out for 4 weeks or more.

3. Patients who voluntarily participated in the trial and obtained document consent.

Exclusion Criteria:

1. a history of acute arterial disease (patients with unstable angina myocardialinfarction, transient ischemic attack, cerebrovascular disease, coronary artery bypassgraft or percutaneous transluminal coronary angioplasty within 3 months prior to studyenrollment)

2. uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic bloodpressure ≥100mmHg)

3. uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)

4. uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upperlimits of normal (ULN))

5. usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.)within 4 weeks before enrollment

6. a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) morethan 2 times the ULN

7. chronic kidney disease (serum creatinine ≥2 times the ULN)

8. elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN)

9. a history of drug or alcohol abuse

10. a history of gastrointestinal surgery or gastrointestinal tract disorders

11. hypersensitivity to the components of this drug

12. those who disagree with contraception

13. pregnancy and/or lactation.