Daiichi Sankyo has begun dosing patients in its largest Phase III trial to test its factor Xa inhibitor edoxaban for the treatment and prevention of recurrent venous thromboembolism (VTE), or blood clots in the veins.
The new study, called HOKUSAI VTE, will evaluate the safety and efficacy ofedoxaban in reducing recurrent VTE complications inpatients with deep-vein thrombosis and/or pulmonary embolism.
It is estimated that more than 900,000 fatal and non-fatal VTE events occur in the US annually, and approximately 300,000 deaths are related to VTE every year.
HOKUSAI VTE chairman of the Steering Committee Harry Büller said that the incidence of VTE is predicted to double by 2050.
"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," Büller said.
HOKUSAI VTE is a Phase III multi-centre study that will include approximately 7,500 patients in more than 450 clinical sites in approximately 40 countries worldwide.