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.