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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Use of ROVASRO for hypercholesterolemia
Use of CRESTOR for hypercholesterolemia
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
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.
Time frame: 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).
Time frame: 8 weeks after treatment
Change in biochemical parameters : total cholesterol (mg/dL)
Percentage changes in total cholesterol (mg/dL).
Time frame: 8 weeks after treatment
Change in biochemical parameters : triglyceride (mg/dL)
Percentage changes in triglyceride (mg/dL).
Time frame: 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).
Time frame: 8 weeks after treatment
Change in biochemical parameters : apolipoprotein B(mg/dL)
Percentage changes in apolipoprotein B(mg/dL).
Time frame: 8 weeks after treatment
Change in biochemical parameters : apolipoprotein A1(mg/dL)
Percentage changes in apolipoprotein A1(mg/dL).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 8 weeks after treatment