A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
Seoul National University Hospital
Seoul, South Korea
% Change of LDL-C
% Change of LDL-C in week 8 from baseline
Time frame: 8 weeks
% Change of LDL-C
% Change of LDL-C in week 4 from baseline
Time frame: 4 weeks
% Change of Lipid parameters
% Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs
Time frame: 4 weeks and 8 weeks
LDL-C goal achievement rates
LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: \< 160 mg/dL, intermediate risk group: \<130 mg/dL, high risk group: \< 100 mg/dL, extreme risk group: \< 70 mg/dL)
Time frame: 4 weeks and 8 weeks
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DW1125A-1
Ezetimibe/Atorvastatin 10/5 mg placebo
Atorvastatin 5mg placebo
Ezetimibe 10mg placebo
Atorvastatin 10mg placebo