A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

CompletadoFase 3ClinicalTrials.gov

ID: NCT00097357Tipo: INTERVENTIONALInicio: 1 de oct de 2004Fin estimado: 1 de dic de 2005

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

Undergoing elective unilateral total knee replacement surgery.
Willing and able to undergo bilateral ascending contrast venography.
Able to inject (by self or caregiver) study medication subcutaneously.

Criterios de exclusión

Women of childbearing potential.
Women who are pregnant or breastfeeding.
Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) \>=35 kg/m2

Intervenciones

drug

Apixaban

Tablets, Oral, 12 +/- 2 days

drug

Enoxaparin

Injection, SQ, Q12H, 12 +/- 2 days

drug

Warfarin

Tablets, Oral, QD, 12 +/- 2 days

drug

Enoxaparin Placebo

Injection, SQ, BID, 12 +/- 2 days

drug

Apixaban Placebo

Tablets, Oral, BID, 12 +/- 2 days

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital fEDERAL, Buenos Aires, Argentina

Local Institution

Prov. Buenos Aires, Buenos Aires, Argentina

Local Institution

Godoy Cruz, Mendoza Province, Argentina

Local Institution

Mendoza, Mendoza Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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