drugset / Trial / NCT01350973
Efficacy of TAK-085 in Participants With Hypertriglyceridemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to determine the efficacy and safety 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
- 2010-12
- Completion
- 2010-12
Outcome
Met primary endpoint
registry TAK-085 4 g vs EPA-E 1.8 g; p < 0.0001; LS Mean Difference -11.35 (95% CI -15.9442 to -6.7637) NCT01350973 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eicosapentaenoic acid-ethyl | Unknown | 0.6 g | Oral |
| Subject | Omega-3-acid ethyl esters 90 | Unknown | 2 g | Oral |