Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
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