1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy 2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized, double blind setting. 3. Phase and design : A multicenter, double blind, randomized, active controlled, parallel-design, Phase 3 study 4. Duration of study : 12 months from the IRB approval date 5. Duration of administration : 4-week single blind run-in period plus 8-week double blind treatment period
This study is to Evaluate the Efficacy and Safety of Pravastatin/Fenofibrate Complex in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy. After administrating the atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) for 8 weeks, evaluate the variation of the Non-HDL-C for each arm. Ultimatly verificaite the Pravafenix Cap. (pravastatin sodium/fenofibrate) have better effects than atorvastatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
302
Pravafenix(Pravastatin40mg/Fenofibrate160mg)
Lipitor 10mg(Atorvastatin Sodium)
Seoul National University Hospital
Seoul, South Korea
Percent change (%) from baseline in Non-HDL-C
Percent change (%) from baseline at Week 8 in Non-HDL-C
Time frame: at Week 8
Percent change (%) from baseline in Non-HDL-C
Percent change (%) from baseline at Week 4 in Non-HDL-C
Time frame: Week 4
◦Percent change (%) from baseline at Week 4 and Week 8 in TG
Percent change (%) from baseline at Week 4 and Week 8 in TG
Time frame: Week 4 and Week 8
Percent change (%) from baseline at Week 4 and Week 8 in TC
Percent change (%) from baseline at Week 4 and Week 8 in TC
Time frame: Week 4 and Week 8
Percent change (%) from baseline at Week 4 and Week 8 in LDL-C
Percent change (%) from baseline at Week 4 and Week 8 in LDL-C
Time frame: Week 4 and Week 8
Percent change (%) from baseline at Week 4 and Week 8 in HDL-C
Percent change (%) from baseline at Week 4 and Week 8 in HDL-C
Time frame: Week 4 and Week 8
Percent change (%) from baseline at Week 4 and Week 8 in Apo A-I
Percent change (%) from baseline at Week 4 and Week 8 in Apo A-I
Time frame: Week 4 and Week 8
Percent change (%) from baseline at Week 4 and Week 8 in Apo B
Percent change (%) from baseline at Week 4 and Week 8 in Apo B
Time frame: Week 4 and Week
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