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

Study Overview
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Brief Summary
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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.

Official Title
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A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

Conditions
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Hypercholesterolemia, Dyslipidemias

Intervention / Treatment
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* Drug: CRESTOR, reference formulation of rosuvastatin
* Drug: ROVASRO, generic formulation of rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged between 19 and 80 years old. 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. Patients who voluntarily participated in the trial and obtained document consent. Exclusion Criteria: 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) uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg) uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl) uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN)) usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more than 2 times the ULN chronic kidney disease (serum creatinine ≥2 times the ULN) elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN) a history of drug or alcohol abuse a history of gastrointestinal surgery or gastrointestinal tract disorders hypersensitivity to the components of this drug those who disagree with contraception pregnancy and/or lactation.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10mg of the generic formulation (rosuvastatin, ROVASRO®)<br>Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®) | Drug: ROVASRO, generic formulation of rosuvastatin<br>* Use of CRESTOR for hypercholesterolemia<br>|
| Active Comparator: 10mg of the reference formulation (rosuvastatin, CRESTOR®)<br>Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®) | Drug: CRESTOR, reference formulation of rosuvastatin<br>* Use of ROVASRO for hypercholesterolemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in the level of LDL-C | Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment. | 8 weeks after treatment | 
| Target achievement rate in the level of LDL-C | Target achievement rate in the level of LDL-C from baseline to week 8 of drug treatment The LDL-C targets were defined as <70 mg/dL for the very high risk group, <100 mg/dL for the high risk group, <130 mg/dL for the moderate risk group, and <160 mg/dL for the low risk group (Committee. KCJ 2016). | 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biochemical parameters : total cholesterol (mg/dL) | Percentage changes in total cholesterol (mg/dL). | 8 weeks after treatment | 
| Change in biochemical parameters : triglyceride (mg/dL) | Percentage changes in triglyceride (mg/dL). | 8 weeks after treatment | 
| Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL) | Percentage changes in high-density lipoprotein-cholesterol(HDL-C)(mg/dL). | 8 weeks after treatment | 
| Change in biochemical parameters : apolipoprotein B(mg/dL) | Percentage changes in apolipoprotein B(mg/dL). | 8 weeks after treatment | 
| Change in biochemical parameters : apolipoprotein A1(mg/dL) | Percentage changes in apolipoprotein A1(mg/dL). | 8 weeks after treatment | 
| Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L) | Percentage changes in high sensitivity C-reactive protein (hsCRP)(mg/L). | 8 weeks after treatment |