NCT02035215

Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia

Efficacy and Safety of Co-administration of Omacor Plus Atorvastatin Compared With Atorvastatin Monotherapy in Patients With Type Ⅱb Dyslipidemia: a Multicenter, Double-blind, Randomized, Active-controlled, Parallel, Phase Ⅲ Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Kuhnil Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia

Conditions

• Hyperlipidemia, Familial Combined

Interventions

Type	Name	Description
DRUG	Atorvastatin 20mg
DRUG	Omega-3-acids ethylesters 90 4g
OTHER	Placebo(Omega-3-acids ethylesters 90)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-01-14
• Last updated: 2014-03-20

Locations

4 sites across 1 country: South Korea