Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Completed · Phase 3 · NCT00781391
Conditions: Stroke, Atrial Fibrillation, Embolism
At a glance
- Research payments reported, 2025
- $70,000
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 21,105
About the trial
- Sponsor
- Daiichi Sankyo (with The TIMI Study Group)
- Tested
- warfarin tablets (drug), Edoxaban tablets (high dose regimen-60mg) (drug), Edoxaban tablets (low dose regimen-30mg) (drug), placebo warfarin (drug), placebo edoxaban (drug)
- Dates
- Started 2008-11; completion 2013-05
- Results posted
- Yes
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.
From ClinicalTrials.gov, last updated 2019-03-05. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Daiichi Sankyo Inc. reported $70,000 in research payments for this study in 2025 (2 payments).
Products named: Savaysa
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.