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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 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 21,105 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00781391
The ClinicalTrials.gov registry entry for NCT00781391 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 21,105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which warfarin tablets is the first listed.
NCT00781391 reports 0 study locations.
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.
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