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NCT00781391 · ClinicalTrials.gov registry record · Phase 3
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 21,105
- Enrollment target
NCT00781391: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT00781391 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 21,105 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2637% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00781391, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 21,105 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
Interventions
- DRUG warfarin tablets
- DRUG Edoxaban tablets (high dose regimen-60mg)
- DRUG Edoxaban tablets (low dose regimen-30mg)
- DRUG placebo warfarin
- DRUG placebo edoxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21,105 participants |
| Start Date | 2008-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT00781391 record still lists
NCT00781391 is an interventional study that assigns participants to a tested intervention. Its 21,105 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2637% higher).
The record links to 0 conditions, and to 5 interventions - of which warfarin tablets is the first listed.
NCT00781391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00781391 about?
NCT00781391 is a clinical study titled "Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation". 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 th...
What is the current status of trial NCT00781391?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 21,105 participants. The study started on 2008-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00781391?
The interventions under investigation include: warfarin tablets (DRUG), Edoxaban tablets (high dose regimen-60mg) (DRUG), Edoxaban tablets (low dose regimen-30mg) (DRUG), placebo warfarin (DRUG), placebo edoxaban (DRUG).
Who is sponsoring clinical trial NCT00781391?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00781391's enrollment target sits among peer trials
21,105 9th of 2000 higher than 1,992 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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