Estudio de Fase 3, aleatorizado, de grupos paralelos, multicéntrico y multinacional para la evaluación de la eficacia y seguridad de heparina (de bajo peso molecular)/edoxabán versus heparina (de bajo peso molecular)/warfarina en sujetos con trombosis venosa profunda (TVP) sintomática y/o embolia pulmonar (EP).

CompletadoFase 3ClinicalTrials.gov

ID: NCT00986154Tipo: INTERVENTIONALInicio: 1 de oct de 2009Fin estimado: 1 de abr de 2013

Resumen

Evaluación de heparina/edoxabán tosilato (DU176b) versus heparina/warfarina en la prevención de la recurrencia de coágulos sanguíneos en pacientes con trombosis venosa profunda aguda sintomática en las piernas y/o coágulos sanguíneos en los pulmones.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female subjects older than the minimum legal adult age (country specific);
Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
Able to provide written informed consent

Criterios de exclusión

thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
Calculated Creatinine clearance (CrCL) \< 30 mL/min;
significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
concurrent treatment with potent P-gp inhibitors;
subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study

Intervenciones

drug

edoxaban tosylate(DU-176b)

edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment

drug

low molecular weight heparin/unfractionated heparin

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

drug

warfarin

tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

Ubicaciones

Investigational Site 1100

Buenos Aires, Argentina

Investigational Site 1103

Buenos Aires, Argentina

Investigational Site 1106

Buenos Aires, Argentina

Investigational Site 1108

Buenos Aires, Argentina

Investigational Site 1104

Córdoba, Argentina

Investigational Site 1110

Pcia de Corrientes, Argentina

Investigational Site 1109

Santa Fe, Argentina

Patrocinadores

PrincipalDaiichi Sankyo

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