RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

CompletadoFase 3ClinicalTrials.gov

ID: NCT00329628Tipo: INTERVENTIONALInicio: 1 de feb de 2006Fin estimado: 1 de mar de 2007

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and female patients aged 18 years or above
Patients scheduled for elective total hip replacement

Criterios de exclusión

Planned, staged total bilateral hip replacement
Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)

Intervenciones

drug

Rivaroxaban (BAY59-7939)

10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days

drug

Enoxaparin

Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days

Ubicaciones

Avellaneda, Buenos Aires, Argentina

Berazategui, Buenos Aires, Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Patrocinadores

PrincipalBayer

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