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news.Daiichi Sankyo Company has completed patient enrollment in its Phase III Engage AF-TIMI 48 clinical study of Edoxaban, a direct, specific, oral Factor Xa inhibitor that is being investigated in two different dosing regimens given once daily, to prevent the occurrence of strokes and systemic embolic events (SEE) in patients with atrial fibrillation (AF).
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Daiichi Sankyo said that the Engage AF-TIMI 48 study began enrollment in November 2008.
The Phase III Engage AF-TIMI 48 clinical study is an event-driven, randomised, double-blind, double-dummy, parallel group, multi-center, multi-national study designed to assess the efficacy and safety of Edoxaban compared to the current standard of care, warfarin.
In the study, the patients are randomised to one of three treatment groups: 30mg Edoxaban once daily, 60mg Eedoxaban once daily, or warfarin, a vitamin K antagonist.
Daiichi Sankyo Pharma Development chief science officer and president Glenn Gormley said that the completion of enrollment for the largest AF outcomes study ever undertaken – Engage AF-TIMI 48 – marks a key milestone in the development of Edoxaban and for Daiichi Sankyo.