drugset / Trial / NCT01350999

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

NCT01350999 ↗

Phase 3 Completed 503 enrolled Takeda
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-11
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Eicosapentaenoic acid-ethyl Unknown 0.6 g Oral
Subject Omega-3-acid ethyl esters 90 Unknown 2 g Oral

Indications