A 24-month, Multi-center, Randomized, Open-label, Non-inferiority Study of Efficacy and Safety Comparing Two Exposures of Concentration-controlled Everolimus With Reduced Cyclosporine Versus 3.0 g Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Heart Transplant Recipients

CompletadoFase 3ClinicalTrials.gov

ID: NCT00300274Tipo: INTERVENTIONALInicio: 1 de ene de 2006Fin estimado: 1 de jul de 2011

Traducción no disponible, mostrando original

Resumen

This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
The graft must be functional at time of randomization.

Criterios de exclusión

Patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants.
Patients who are recipients of ABO incompatible transplants.

Intervenciones

drug

everolimus

Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.

drug

mycophenolate mofetil

Mycophenolate mofetil supplied as 500 mg tablets.

drug

cyclosporine

Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.

drug

corticosteroids

Corticosteroids standard dose.

Ubicaciones

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Fundacion Favalaro

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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