Bayer completes Ph II rivaroxaban study enrollment

German drug major Bayer Schering Pharma revealed at the European Society of Cardiology Congress in Barcelona, Spain, that it has completed patient enrollment into the Phase III ROCKET AF study (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF study is assessing the efficacy and safety of rivaroxaban (Xarelto) 20mg once-daily, a novel oral, direct Factor Xa inhibitor, compared to the current standard of care, warfarin, a vitamin K antagonist (VKA)
dose-adjusted, for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF).

"We are most encouraged by the excellent progress of the ROCKET AF study in atrial fibrillation and look forward to the study results in 2010," said Kemal Malik, member of the Bayer HealthCare Executive Committee and chief medical Ooficer.

ROCKET AF is a prospective, randomized, double-blind, double-dummy study including 14,269 patients from more than 1,100 centers across 45 countries, worldwide.