Daiichi Sankyo Completes Enrolment in Hokusai - VTE, investigating once-daily Edoxaban in the Largest Single Phase 3 Study for the Treatment and Prevention of Recurrence of VTE

Daiichi Sankyo Completes Enrolment in Hokusai - VTE, investigating once-daily Edoxaban in the Largest Single Phase 3 Study for the Treatment and Prevention of Recurrence of VTE PR Newswire TOKYO, October 25, 2012 TOKYO, October 25, 2012 /PRNewswire/ -- Edoxaban is an investigational, once daily, novel oral factor Xa inhibitor Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has completed patient enrolment in the global Hokusai-VTE phase 3 study investigating the once-daily oral factor Xa inhibitor edoxaban for the treatment and prevention of recurrence of venous thromboembolism (VTE) in patients who have had an acute symptomatic deep [1],[2]vein thrombosis (DVT), pulmonary embolism (PE), or both. Hokusai-VTE is the largest single phase 3 clinical study in the treatment and prevention of recurrence of VTE. More [1],[2]than 8,250 patients have been enrolled in the trial from more than 400 clinical sites across 38 countries worldwide. The Hokusai-VTE clinical study has been designed to reflect clinical practice, using a standard heparin lead-in, and providing a flexible treatment duration of three, six or 12 months. Edoxaban 60mg once-daily will be compared to [2] warfarin control therapy (target INR 2-3). This study design is allowing investigators to evaluate patients with a broad [1],[3],[4]range of risks, including patients with moderate or severe conditions of PE and DVT.