The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.
Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study Primary Outcome Measure: The mean percent change of Non-HDL Cholesterol \[Time Frame: from baseline at week 8\] Secondary Outcome Measures: The achievement rate of LDL-C\<100mg/dl, Non-HDL-C\<130mg/dl \[Time Frame: from baseline at week 8\] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B \[Time Frame: from baseline at week 4, 8\] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI \[Time Frame: from baseline at week 4, 8\] The mean percent change of Fibrinogen, hs-CRP \[Time Frame: from baseline at week 4, 8\] Safety evaluation \[Time Frame: Treatment period and Extension period\]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
476
\[Atorvastatin Run-in Period\] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) \[Treatment Period\] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) \[Extension Period\] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)
Refer to Intervention Description of Atorvastatin 20mg
Refer to Intervention Description of Atorvastatin 20mg
The mean percent change of Non-HDL Cholesterol
Time frame: from baseline at week 8
The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl
Time frame: from baseline at week 8
The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B
Time frame: from baseline at week 4, 8
The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI
Time frame: from baseline at week 4, 8
The mean percent change of Fibrinogen, hs-CRP
Time frame: from baseline at week 4, 8
Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)
Time frame: Treatment period (8 weeks) and Extension period (16 weeks)
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