drugset / Trial / NCT00338897
Dose Ranging Study in Elective Total Hip Replacement Surgery
RandomizedParallel-groupDouble-blindPrevention
Summary
The primary objective is to: * demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. The secondary objectives are to: * evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and * to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.
Timeline
- Start
- 2006-05
- Primary completion
- 2007-05
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SR123781A | Oligonucleotide (other) | 0.25 mg | Subcutaneous |
| Subject | SR123781A | Oligonucleotide (other) | 0.5 mg | Subcutaneous |
| Subject | SR123781A | Oligonucleotide (other) | 1 mg | Subcutaneous |
| Subject | SR123781A | Oligonucleotide (other) | 2 mg | Subcutaneous |
| Subject | SR123781A | Oligonucleotide (other) | 4 mg | Subcutaneous |