Daiichi Sankyo announced that it has completed patient enrollment for its Phase 3 study of edoxaban, to prevent the occurrence of strokes and systemic embolic events (SEE) in patients with atrial fibrillation (AF). This study (known as the ENGAGE AF-TIMI 48 trial) is an event-driven, randomized, double-blind, double-dummy, parallel group, multi-centre, multi-national study designed to assess the efficacy and safety of edoxaban compared to the current standard of care, warfarin. Patients in the study are randomized to one of three treatment groups: 30 mg edoxaban once-daily, 60 mg edoxaban once-daily, or warfarin, a vitamin K antagonist. In addition, edoxaban doses are further adjusted to treat patients with renal impairment and/or low body weight, or those taking strong P-glycoprotein inhibitors. Those randomized to warfarin are dosed once-daily to achieve an International Normalized Ratio (INR) between 2.0 and 3.0.
Edoxaban is a direct, specific, oral Factor Xa inhibitor that is being investigated in two different dosing regimens given once-daily.
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