Evaluation of edoxaban vs. warfarin in subjects with symptomatic VTE

• Research type

  Research Study

• Full title

  A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism

• IRAS ID

  36080

• Contact name

  Alexander Cohen

• Sponsor organisation

  Daiichi Sankyo Development Limited

• Eudract number

  2009-014290-40

• Clinicaltrials.gov Identifier

  NCT00986154

• Research summary

  Deep-vein thrombosis (DVT) and pulmonary embolism (PE or thrombosis in the lung) are referred to as venous thromboembolism (VTE). VTE can cause serious illness and even death and is a common disorder affecting yearly about 2-3 per 1000 inhabitants. Vitamin K Antagonists (VKA), such as warfarin, are commonly used anticoagulants (also called Ó?blood thinners?), for the treatment of this condition. However there are inherent risks associated with the use of products like warfarin. Many drug and food interactions impair the effectiveness and there is the need for frequent blood monitoring to manage dose administration. For these reasons, easier to use drugs are being investigated in clinical studies. This study is performed to compare the safety and efficacy of edoxaban (a new anticoagulant, not yet approved by the health authorities), with warfarin in patients with VTE. If demonstrated to be safe and effective, edoxaban could represent a potential alternative treatment to warfarin. Patients will be assigned by chance to one of two treatment groups: edoxaban or warfarin. All patients will also receive heparin (an anticoagulant that is injected) for at least 5 days, which is required for initial treatment. This is a blinded study, so neither the patient nor the study doctor will know which treatment (warfarin or edoxaban) the patients are receiving. Patients will stay in the study for a maximum or 12 months and be seen by their study doctor every month. If the doctor decides that the treatment can be stopped earlier, the patients will be followed up for the remainder of the 12 months with visits every 3 months. An independent study overview committee of expert doctors will monitor the safety and well being of subjects during the study. This study is being funded by Daiichi Sankyo Pharma Development and will be recruiting about 7,500 patients from 450 hospitals worldwide.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  09/H0713/77

• Date of REC Opinion

  10 Feb 2010

• REC opinion

  Further Information Favourable Opinion