BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
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
- —
Outcome
Mixed primary results
registry BIBR 1048 225 mg Bid vs Enoxaparin 40 mg qd; p = 0.0007; Odds Ratio (OR) 0.469 (95% CI 0.302 to 0.727); Regression, Logistic NCT01225822 ↗
registry BIBR 1048 50 mg Bid vs Enoxaparin 40 mg qd; p = 0.0472; Odds Ratio (OR) 0.121 (95% CI 0.015 to 0.974); Regression, Logistic NCT01225822 ↗
registry BIBR 1048 150 mg Bid vs Enoxaparin 40 mg qd; p = 0.1043; Odds Ratio (OR) 2.049 (95% CI 0.862 to 4.868); Regression, Logistic NCT01225822 ↗
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 |