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Combined Dyslipidemia clinical trials

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NCT ID: NCT02166593 Completed - Clinical trials for Combined Dyslipidemia

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

Start date: May 2014
Phase: Phase 3
Study type: Interventional

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