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NCT00402467 · ClinicalTrials.gov registry record · Phase 2
An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 613
- Enrollment target
NCT00402467 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 613 participants.
The verdict
NCT00402467, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 613 participants
- Enrollment target
Study Summary
The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously. In this study 4 different doses of the investigational drug BAY59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II, Dose III, Dose IV. This study will run for approximately 7 months in a number of countries. In total, up to 600 patients may participate in this study.
Interventions
- DRUG Rivaroxaban (BAY59-7939)
- DRUG Rivaroxaban, (BAY59-7939)
- DRUG Enoxaparine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 613 participants |
| Start Date | 2004-02 |
| Est. Completion | 2004-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402467
The ClinicalTrials.gov registry entry for NCT00402467 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 613 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 3 interventions - of which Rivaroxaban (BAY59-7939) is the first listed.
NCT00402467 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00402467 about?
NCT00402467 is a clinical study titled "An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study". The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. The purpose of this study is to compare the safety and effica...
What is the current status of trial NCT00402467?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 613 participants. The study started on 2004-02. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00402467?
The interventions under investigation include: Rivaroxaban (BAY59-7939) (DRUG), Rivaroxaban, (BAY59-7939) (DRUG), Enoxaparine (DRUG).
Who is sponsoring clinical trial NCT00402467?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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