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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 3,449 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00440193
The ClinicalTrials.gov registry entry for NCT00440193 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,449 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.
NCT00440193 reports 0 study locations.
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.
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