TOKYO, MUNICH, Germany and EDISON, New Jersey, December 7 /PRNewswire/ --
- ENGAGE-AF TIMI 48 Trial to Study 16,500 Patients in More Than 1,400 Centers Globally
DAIICHI SANKYO Company, Limited (TSE: 4568), announced today that it has initiated its pivotal Phase III trials for DU-176b, an investigational oral Factor Xa inhibitor, in patients with atrial fibrillation. DU-176b is being developed solely by DAIICHI SANKYO.
The Phase III global study, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation (ENGAGE-AF TIMI 48), will compare DU-176b with warfarin in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation. The primary safety assessment will be the incidence of bleeding.