NCT03949374CompletedPhase 4
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Percentage change in the level of LDL-C
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
10mg of the generic formulation (rosuvastatin, ROVASRO®)
Active Comparator
Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)
Intervention: ROVASRO, generic formulation of rosuvastatin (Drug)
10mg of the reference formulation (rosuvastatin, CRESTOR®)
Active Comparator
Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Intervention: CRESTOR, reference formulation of rosuvastatin (Drug)
Outcomes
Primary Outcomes
Percentage change in the level of LDL-C
Time Frame: 8 weeks after treatment
Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment.
Target achievement rate in the level of LDL-C
Time Frame: 8 weeks after treatment
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).
Secondary Outcomes
- Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)(8 weeks after treatment)
- Change in biochemical parameters : total cholesterol (mg/dL)(8 weeks after treatment)
- Change in biochemical parameters : triglyceride (mg/dL)(8 weeks after treatment)
- Change in biochemical parameters : apolipoprotein B(mg/dL)(8 weeks after treatment)
- Change in biochemical parameters : apolipoprotein A1(mg/dL)(8 weeks after treatment)
- Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L)(8 weeks after treatment)
Investigators
Study Sites (1)
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