Daiichi Sankyo has completed enrolment in its Hokusai-VTE Phase III study evaluating edoxaban to treat and prevent reoccurrence of venous thromboembolism (VTE) in patients who have had an acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both.
Edoxaban is an investigational, once daily, novel oral factor Xa inhibitor licensed only in Japan for the prevention of VTE after major orthopaedic surgery, under the brand name Lixiana.
Hokusai-VTE steering committee chairman, the Academic Medical Center in Amsterdam department of vascular medicine chairman, internal medicine professor Dr Harry Büller said Hokusai-VTE marks an important step in the development of the new class of oral anticoagulants, direct factor Xa inhibitors due to its design and large patient population.
"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," Buller said.
The Hokusai-VTE Phase III study enrolled more than 8,250 patients from more than 400 clinical sites across 38 countries worldwide.
The study, which compares edoxaban 60mg once-daily to warfarin control therapy, is designed to reflect clinical practice, using a standard heparin lead-in, and providing a flexible treatment duration of three, six or 12 months.
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Investigators can evaluate patients with a range of risks, including patients with moderate or severe conditions of PE and DVT, using the study design.
Daiichi Sankyo senior executive officer, research and development global head Glenn Gormley said; "We are very pleased to announce that we have completed patient recruitment for the Hokusai-VTE clinical study, the largest global study of its kind and we expect to see first results during FY 2013."