1992 patients undergoing elective total hip arthroplasty were randomized to receive either oral darexaban (YM150) (at 15 mg bid, 30 mg qd, 30 mg bid, or 60 mg qd) or 40 mg enoxaparin qd. Incidence of VTEs or death was the primary outcome, and incidence of bleeding and adverse events were part of the safety analysis. No significant differences were found between bid and qd darexaban dosing, as well as daily totals of 30 or 60 mg with respect to VTE occurrence. No significant difference was found when compared to enoxaparin after study period. Majority of the VTE and bleeding events occurred during the first 12 days. Medication in all groups was well tolerated with no significant differences.