Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00439777 · ClinicalTrials.gov registry record · Phase 3
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,833
- Enrollment target
NCT00439777: Completed Phase 3 study, sponsored by Bayer.
NCT00439777 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 4,833 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (526% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439777, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,833 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 pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).
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 overlapping with and followed by VKA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,833 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00439777 record still lists
NCT00439777 is an interventional study that assigns participants to a tested intervention. Its 4,833 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 (526% higher).
The record links to 0 conditions, and to 2 interventions - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT00439777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439777 about?
NCT00439777 is a clinical study titled "Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE 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 pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein...
What is the current status of trial NCT00439777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,833 participants. The study started on 2007-03. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00439777?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Enoxaparin overlapping with and followed by VKA (DRUG).
Who is sponsoring clinical trial NCT00439777?
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 NCT00439777's enrollment target sits among peer trials
4,833 53rd of 2000 higher than 1,948 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01719055 · 4,800 participants
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
- NCT05485675 · 4,800 participants · NA
Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program
- NCT06307652 · 4,800 participants · Phase 3
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
- NCT05252754 · 4,874 participants · Phase 3
Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia