February 5, 2010 – A new, large-scale pivotal phase III trial has been initiated for edoxaban to evaluate its safety and efficacy in reducing recurrent venous thromboembolic (VTE) complications in patients with deep-vein thrombosis (DVT) and/or pulmonary embolism (PE).
The primary efficacy endpoint for the HOKUSAI VTE trial is the recurrence of symptomatic VTE (i.e., the composite of DVT, nonfatal PE and fatal PE). The primary safety assessment of the trial is the incidence of major and clinically relevant non-major bleeding. Edoxaban is an investigational oral Factor Xa inhibitor
"The incidence of VTE is predicted to double by 2050," said Harry R. Büller, M.D., professor of internal medicine, chairman of the department for vascular medicine at the Academic Medical Center, Amsterdam and chairman of the steering committee for HOKUSAI VTE. "Based on what we've seen in phase II and other trials, edoxaban shows promise as an agent to help fulfill the need for treatment options that are safe, effective and more convenient than the current standard of care, which requires extensive monitoring, careful dose adjusting and may have the potential for various drug and food interactions."
HOKUSAI VTE is the largest, single phase III study ever undertaken in the area of VTE. The multicenter study that will include approximately 7,500 patients in more than 450 clinical sites in approximately 40 countries worldwide. This is an event-driven, randomized, double-blind, double-dummy, parallel-group, multicenter, multinational study, which will randomize patients to two different treatment groups. Both groups will receive open label enoxaparin or unfractionated heparin for at least five days and up to 12 days, followed by double-blind warfarin or edoxaban 60 mg once-daily. Patients will be treated for up to 12 months in accordance to the standard of care and international guidelines.
For more information: www.daiichisankyo.com