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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
Date:10/25/2012

TOKYO, Oct. 25, 2012 /PRNewswire/ -- 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 vein thrombosis (DVT), pulmonary embolism (PE), or both.1,2

Hokusai-VTE is the largest single phase 3 clinical study in the treatment and prevention of recurrence of VTE. More than 8,250 patients have been enrolled in the trial from more than 400 clinical sites across 38 countries worldwide.1,2

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 warfarin control therapy (target INR 2-3).2   This study design is allowing investigators to evaluate patients with a broad range of risks, including patients with moderate or severe conditions of PE and DVT.1,3,4

"With its rigorous design and large patient population, Hokusai-VTE marks an important step in the development of the new class of oral anticoagulants, direct factor Xa inhibitors," said Professor Harry Buller, MD, PhD, Professor of Internal Medicine, Chairman of the Department of Vascular Medicine at the Academic Medical Center in Amsterdam, The Netherlands and Chairman of the Hokusai-VTE steering committee. "What sets the Hokusai-VTE study apart from other studies of its kind is that it aims to reflect clinical practice through the flexible treatment duration." 

Edoxaban is an investigational once-daily, novel oral anticoagulant that specifically, reversibly and directly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood
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SOURCE Daiichi Sankyo
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