drugset / Trial / NCT00396786
Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.
Timeline
- Start
- 2004-11
- Primary completion
- 2005-07
- Completion
- 2005-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enoxaparin sodium | Other / unclassified | 40 mg | — |
| Subject | Rivaroxaban | Other / unclassified | 5 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 10 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 20 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 30 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 40 mg | Oral |