Clinical trial
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein…
NCT00362232 · Bayer, Industry · Completed
Key facts
| NCT number | NCT00362232 |
|---|---|
| Title | 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. |
| Official title | RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement |
| Acronym | RECORD 4 |
| Lead sponsor | Bayer, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Venous Thromboembolism |
| Intervention type | Drug |
| Interventions | Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin, Placebo: tablet of Rivaroxaban, Placebo: syringes of Enoxaparin |
| Enrollment | 3,148 |
| Start date | Jun 1, 2006 |
| Primary completion | Jan 1, 2007 |
| Completion | Jan 1, 2008 |
| First posted | Aug 9, 2006 |
| Last update posted | Nov 4, 2014 |
| Countries | Bulgaria, Canada, Denmark, India, Israel, Lithuania, Mexico, Norway, Pakistan, Poland, Sri Lanka, Sweden and 1 more |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: