drugset / Trial / NCT00338897

Dose Ranging Study in Elective Total Hip Replacement Surgery

NCT00338897 ↗

Phase 2/3 Completed 1090 enrolled Sanofi
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

EvaluationDrugModalityDoseRoute
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