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NCT00362232 · ClinicalTrials.gov registry record · Phase 3
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
A Phase 3 study of Venous Thromboembolism, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,148
- Enrollment target
- 20
- Study locations
NCT00362232: Completed Phase 3 study of Venous Thromboembolism, sponsored by Bayer.
NCT00362232 is a Phase 3 study of Venous Thromboembolism that has completed, run by Bayer. The registered enrollment target is 3,148 participants, below the 6,229-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00362232, a Phase 3 study of Venous Thromboembolism, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,148 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
Primary Outcome
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Conditions Studied
Interventions
- DRUG Enoxaparin
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
- DRUG Placebo: tablet of Rivaroxaban
- DRUG Placebo: syringes of Enoxaparin
Study Locations (20)
Florida
- - Boynton Beach
- - Clearwater
- - DeLand
- - Hollywood
- - Jacksonville
- - Pensacola
- - Pinellas Park
California
- - Bakersfield
- - Encinitas
- - Fountain Valley
- - La Jolla
- - Torrance
- - Yuba City
Colorado
- - Centennial
- - Denver
- - Englewood
Alabama
- - Birmingham
- - Tuscaloosa
Arizona
- - Phoenix
Arkansas
- - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,148 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00362232 record still lists
NCT00362232 is an interventional study that assigns participants to a tested intervention. Its 3,148 participants enrollment target places it among the larger protocols in the corpus, below the 6,229-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 4 interventions - of which Enoxaparin is the first listed.
NCT00362232 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00362232 about?
NCT00362232 is a clinical study titled "Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.". The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
What is the current status of trial NCT00362232?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,148 participants. The study started on 2006-06. Estimated completion is 2008-01.
What conditions does trial NCT00362232 study?
This clinical trial studies the following conditions: Venous Thromboembolism.
What interventions are being tested in trial NCT00362232?
The interventions under investigation include: Enoxaparin (DRUG), Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Placebo: tablet of Rivaroxaban (DRUG), Placebo: syringes of Enoxaparin (DRUG).
Who is sponsoring clinical trial NCT00362232?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00362232 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00362232's enrollment target sits among peer trials
3,148 15th of 47 higher than 33 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism 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.
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