A Multicenter, Randomized, Double-Blind, Double Dummy, Parallel Group, Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

CompletadoFase 3ClinicalTrials.gov

ID: NCT00338897Tipo: INTERVENTIONALInicio: 1 de may de 2006Fin estimado: 1 de may de 2007

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry

Criterios de exclusión

Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization
Known progressive malignant disease
Ischemic stroke in the last 3 months
Myocardial infarction (MI) in the last 3 months
Any major orthopedic surgery in the 3 months prior to study start
Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments)
Treatment with other antithrombotic agents within 7 days prior to surgery

Intervenciones

drug

SR123781A

Ubicaciones

Sanofi-Aventis

San Isidro, Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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