The Phase III global study will compare DU-176b with warfarin in preventing stroke and systemic embolic events in patients with atrial fibrillation. The primary safety assessment will be the incidence of bleeding.
Results from a recently announced Phase II safety study showed that the incidence of major and clinically relevant non-major bleeding events reported in the once-daily DU-176b treatment groups (30mg or 60mg) was similar to that in the warfarin-treated patient group. The incidence of major and clinically relevant non-major bleeding events was significantly higher in the twice-daily DU-176b treatment groups (30mg or 60mg), compared to the warfarin group.
The Phase III study will therefore randomize approximately 16,500 patients to one of three treatment groups: 30mg DU-176b once daily, 60mg DU-176b once daily, or warfarin. Those randomized to warfarin will be dosed once daily with dose adjustments to maintain international normalized ratio between 2.0 and 3.0.
This Phase III study is an event-driven, multinational, randomized, double-blind study with sites in North and South America, Africa, Asia, Europe, Australia and New Zealand. The expected median treatment duration of the study is 24 months and Daiichi Sankyo expects the study to conclude in the first half of 2012.
John Alexander, global head of R&D at Daiichi Sankyo Company, said: The start of our Phase III trial marks an important milestone in the clinical development of DU-176b and we hope this compound will prove to be another successful treatment in our cardiovascular portfolio.