A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
396
Seoul National University Hospital
Seoul, South Korea
Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: baseline and 8 week
Percent change from baseline to 4 and 8 week in Total Cholesterol
Time frame: baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in Triglyceride
Time frame: baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in HDL-Cholesterol
Time frame: baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol
Time frame: baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in Apolipoprotein B
Time frame: baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in Apolipoprotein A1
Time frame: baseline to 4 and 8 week
Percent change from baseline to 4 week in LDL-Cholesterol
Time frame: baseline to 4 week
Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)
Time frame: baseline to 4 and 8
The change of LDL-Cholesterol/HDL-Cholesterol ratio
Time frame: baseline to 4 and 8 week
The change of Total Cholesterol/HDL-Cholesterol ratio
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Time frame: baseline to 4 and 8 week
The change of non-HDL-Cholesterol/HDL-Cholesterol ratio
Time frame: baseline to 4 and 8 week
The change of Apolipoprotein B/Apolipoprotein A1 ratio
Time frame: baseline to 4 and 8 week
The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline
Time frame: baseline to 4 and 8 week