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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,197 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00439725
The ClinicalTrials.gov registry entry for NCT00439725 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,197 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 Placebo is the first listed.
NCT00439725 reports 0 study locations.
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.
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