A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

CompletadoFase 3ClinicalTrials.gov

ID: NCT00643201Tipo: INTERVENTIONALInicio: 1 de jul de 2008Fin estimado: 1 de mar de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men and women ≥ 18 years of age
Clinical diagnosis of DVT or PE

Criterios de exclusión

Contraindications for enoxaparin or warfarin
Active bleeding or high risk for serious bleeding
Short life expectancy
Uncontrolled high blood pressure
Significantly impaired kidney or liver function

Intervenciones

drug

Enoxaparin

solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.

drug

warfarin

tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

drug

Placebo for apixaban

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

drug

Placebo for enoxaparin

solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.

drug

Placebo for warfarin

tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

drug

apixaban

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution

Corrientes, Corrientes Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorPfizer

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