A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
385
Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
The catholic university of korea seoul st. Mary's hospital
Seoul, South Korea
Change form baseline in LDL-C
Time frame: up to week 8
Change form baseline in LDL-C
Time frame: up to week 20
Change form baseline in Total cholesterol
Time frame: up to week 20
Change form baseline in Triglyceride
Time frame: up to week 20
Change form baseline in HDL-C
Time frame: up to week 20
Change form baseline in Non-HDL-C
Time frame: up to week 20
Change form baseline in LDL-C/HDL-C ratio
Time frame: up to week 20
Change form baseline in TC/HDL-C ratio
Time frame: up to week 20
Change form baseline in Non-HDL-C/HDL-C ratio
Time frame: up to week 20
Change form baseline in Apo-B ratio
Time frame: up to week 20
Change form baseline in Apo-B
Time frame: up to week 20
Change form baseline in Apo-A1
Time frame: up to week 20
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Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
Change form baseline in Apo-B/Apo-A1 ratio
Time frame: up to week 20