Dyslipidemias, Hypercholesterolemia
Conditions
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.
Interventions
DRUGCRESTOR, reference formulation of rosuvastatin
Use of ROVASRO for hypercholesterolemia
DRUGROVASRO, generic formulation of rosuvastatin
Use of CRESTOR for hypercholesterolemia
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in the level of LDL-C | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL) | 8 weeks after treatment | Percentage changes in high-density lipoprotein-cholesterol(HDL-C)(mg/dL). |
| Change in biochemical parameters : apolipoprotein B(mg/dL) | 8 weeks after treatment | Percentage changes in apolipoprotein B(mg/dL). |
| Change in biochemical parameters : total cholesterol (mg/dL) | 8 weeks after treatment | Percentage changes in total cholesterol (mg/dL). |
| Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L) | 8 weeks after treatment | Percentage changes in high sensitivity C-reactive protein (hsCRP)(mg/L). |
| Change in biochemical parameters : apolipoprotein A1(mg/dL) | 8 weeks after treatment | Percentage changes in apolipoprotein A1(mg/dL). |
| Change in biochemical parameters : triglyceride (mg/dL) | 8 weeks after treatment | Percentage changes in triglyceride (mg/dL). |
Countries
South Korea
Outcome results
None listed