The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.
The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
347
Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
Pitavastatin ca 2mg
The mean percentage change of Non-HDL Cholesterol
Change rate of Non-HDL-C after 8 weeks compared to baseline (%)
Time frame: from baseline at week 8
The mean percentage change of Non-HDL Cholesterol
Change rate of Non-HDL-C after 4 weeks compared to baseline (%)
Time frame: from baseline at week 4
The mean percentage change of LDL-C
Change rate of LDL-C after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of HDL-C
Change rate of HDL-C after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of LDL-C/HDL-C
Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of TC/HDL-C
Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of non-HDL-C/HDL-C
Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of VLDL-C
Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: from baseline at week 4,8
The mean percentage change of TG
Change rate of TG after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of TC
Change rate of TC after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of Apo Al
Change rate of Apo Al after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of Apo B
Change rate of Apo B change after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of Apo Al/Apo B
Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of fibrinogen
Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
The mean percentage change of hs-CRP
Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%)
Time frame: from baseline at week 4,8
Achievement rate(%) of treatment goals after 4 weeks and 8 weeks
LDL-C\<100mg/dL \& non-HDL-C \<130mg/dL
Time frame: from baseline at week 4,8