NCT01350999

Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia

A Phase 3 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Detailed description

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)). This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification. The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	omega-3-acid ethyl esters 90 (TAK-085)	Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
DRUG	Eicosapentaenoic acid-ethyl (EPA)	EPA-E capsules

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-05-10
• Last updated: 2016-09-20
• Results posted: 2016-09-20