Combined Dyslipidemia Clinical Trial
Official title:
A Study 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
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. ;