Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin

Summary

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

Timeline

Start

2014-05

Primary completion

2018-01

Completion

2018-01

Drugs

Indications