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NCT00439725 · ClinicalTrials.gov registry record · Phase 3
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,197
- Enrollment target
NCT00439725: Completed Phase 3 study, sponsored by Bayer.
NCT00439725 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,197 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439725, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,197 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).
Primary Outcome
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of D
Interventions
- DRUG Placebo
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,197 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00439725 record still lists
NCT00439725 is an interventional study that assigns participants to a tested intervention. Its 1,197 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00439725 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439725 about?
NCT00439725 is a clinical study titled "Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study". This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are el...
What is the current status of trial NCT00439725?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,197 participants. The study started on 2007-02. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00439725?
The interventions under investigation include: Placebo (DRUG), Rivaroxaban (Xarelto, BAY59-7939) (DRUG).
Who is sponsoring clinical trial NCT00439725?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439725's enrollment target sits among peer trials
1,197 228th of 2000 higher than 1,773 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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