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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 4,833 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00439777
The ClinicalTrials.gov registry entry for NCT00439777 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,833 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT00439777 reports 0 study locations.
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.
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