drugset / Trial / NCT01225822
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
RandomizedParallel-groupDouble-blindPrevention
Summary
The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.
Timeline
- Start
- 2002-11
- Primary completion
- 2003-08
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran etexilate | Unknown | 50 mg | — |
| Subject | Dabigatran etexilate | Unknown | 150 mg | — |
| Subject | Dabigatran etexilate | Unknown | 225 mg | — |
| Subject | Dabigatran etexilate | Unknown | 300 mg | — |
| Comparator | Enoxaparin sodium | Other / unclassified | 40 mg | Subcutaneous |