Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
This 8 weeks, prospective, single center, randomized, open-label, parallel-group,
 non-inferiority study was performed from October 2015 to April 2018. This study as designed
 to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin,
 ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with
 primary hypercholesterolemia and complex dyslipidemia.
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 group
 according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ
 2016).

 -  Very high risk group (coronary artery disease, ischemic stroke, peripheral
 vascular disease) were not receiving lipid-lowering agents (statins) within 4
 weeks 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 of
 screening, 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 myocardial
 infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass
 graft or percutaneous transluminal coronary angioplasty within 3 months prior to study
 enrollment)

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

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

 4. uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper
 limits 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) more
 than 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.