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NCT00440193 · ClinicalTrials.gov registry record · Phase 3
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,449
- Enrollment target
NCT00440193: Completed Phase 3 study, sponsored by Bayer.
NCT00440193 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 3,449 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (347% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00440193, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,449 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
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.
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
- DRUG Enoxaparin followed by VKA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,449 participants |
| Start Date | 2007-03 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00440193 record still lists
NCT00440193 is an interventional study that assigns participants to a tested intervention. Its 3,449 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 (347% higher).
The record links to 0 conditions, and to 2 interventions - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT00440193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00440193 about?
NCT00440193 is a clinical study titled "Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study". This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
What is the current status of trial NCT00440193?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,449 participants. The study started on 2007-03. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00440193?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Enoxaparin followed by VKA (DRUG).
Who is sponsoring clinical trial NCT00440193?
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 NCT00440193's enrollment target sits among peer trials
3,449 70th of 2000 higher than 1,931 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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