NCT02166593

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Yooyoung Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Combined Dyslipidemia

Interventions

Type	Name	Description
DRUG	Pravastatin40mg/Fenofibrate160mg	Pravafenix(Pravastatin40mg/Fenofibrate160mg)
DRUG	Atorvastatin Sodium 10mg	Lipitor 10mg(Atorvastatin Sodium)

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2014-06-18
• Last updated: 2018-09-28

Locations

1 site across 1 country: South Korea