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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief 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

Detailed Summary:
Sponsor: Kuhnil Pharmaceutical Co., Ltd.

Current Primary Outcome: The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 8 ]

Original Primary Outcome: The mean percent change of TG(Triglyceride) [ Time Frame: from baseline at week 8 ]

Current Secondary Outcome:

  • The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 4 ]
  • The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C [ Time Frame: from baseline at week 4,8 ]


Original Secondary Outcome:

  • The mean percent change of TG(Triglyceride) [ Time Frame: from baseline at week 4 ]
  • The mean percent change of TC(Total Cholesterol), LDL-C, HDL-C [ Time Frame: from baseline at week 4,8 ]


Information By: Kuhnil Pharmaceutical Co., Ltd.

Dates:
Date Received: January 10, 2014
Date Started: January 2014
Date Completion: December 2014
Last Updated: March 19, 2014
Last Verified: March 2014