Date: 2016-08-24
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Daiichi Sankyo (Japan)
Product: edoxaban
Action
mechanism: blood coagulation factor XA inhibitor/antithrombotic. Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation). The results from these trials form the basis of the MAA for edoxaban for the prevention of stroke and SEE in patients with NVAF, as well as for the treatment of DVT or PE and prevention of recurrence of symptomatic VTE.
Disease: non-valvular atrial fibrillation
Therapeutic area: Cardiovascular diseases
Country: Japan
Trial
details: ELDERCARE-A is a phase 3 clinical trial in Japan to verify the safety and efficacy (prevention of stroke and systemic embolism) of 15 mg once-daily oral administration of edoxaban to non-valvular atrial fibrillation patients who are not eligible for current available oral anticoagulation therapy with an approved dose regimen of VKA (vitamin K antagonist) or DOACs (direct oral anticoagulants) and are aged 80 years and older.
Latest
news: * On August 24, 2016, Daiichi Sankyo announced that it has initiated the ELDERCARE-A?edoxaban low-dose for elder care AF patients study aimed at additional dosage and formulation for patients with non-valvular atrial fibrillation for the anticoagulant edoxaban developed by Daiichi Sankyo.
