A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
382
Chungbuk National University Hospital
Cheongju-si, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: baseline and 8 week
Percent change from baseline to 4 week in LDL-Cholesterol
Time frame: baseline and 4 week
The change in the LDL-C level from the baseline to Week 4 and Week 8
Time frame: baseline to 4 and 8 week
The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8
Time frame: baseline to 4 and 8 week
The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8
Time frame: baseline to 4 and 8 week
The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8
Time frame: baseline to 4 and 8 week
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Chungnam National University Hospital
Daejeon, South Korea
Dongguk University Ilsan Hospital
Goyang-si, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Boramae Hospital
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
...and 10 more locations