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NCT00742859 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
A Phase 2 study, sponsored by Portola Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 508
- Enrollment target
NCT00742859: Completed Phase 2 study, sponsored by Portola Pharmaceuticals.
NCT00742859 is a Phase 2 study that has completed, run by Portola Pharmaceuticals. The registered enrollment target is 508 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (282% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00742859, a Phase 2 study, has completed, sponsored by Portola Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 508 participants
- Enrollment target
Study Summary
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.
Primary Outcome
The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution
Interventions
- DRUG Warfarin
- DRUG betrixaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 508 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00742859 record still lists
NCT00742859 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (282% higher).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT00742859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00742859 about?
NCT00742859 is a clinical study titled "Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin". Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normali...
What is the current status of trial NCT00742859?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 508 participants. The study started on 2008-10. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00742859?
The interventions under investigation include: Warfarin (DRUG), betrixaban (DRUG).
Who is sponsoring clinical trial NCT00742859?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00742859's enrollment target sits among peer trials
508 69th of 2000 higher than 1,932 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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