drugset / Trial / NCT00718224
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective knee replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.
Timeline
- Start
- 2008-07
- Primary completion
- 2009-05
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enoxaparin sodium | Other / unclassified | 20 mg | Subcutaneous |
| Comparator | Enoxaparin sodium | Other / unclassified | 30 mg | Subcutaneous |
| Subject | Semuloparin | Other / unclassified | 10 mg | Subcutaneous |
| Subject | Semuloparin | Other / unclassified | 20 mg | Subcutaneous |