NCT00300274
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
PHASE3
COMPLETED
NCT00300274
INTERVENTIONAL
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
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.
Inclusion Criteria:
* Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
* The graft must be functional at time of randomization.
Exclusion Criteria:
* 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.
Other protocol-defined inclusion/exclusion criteria may apply.
Graft Rejection
- TREATMENT
-
- Type: DRUG
- Name: everolimus
- Description: Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
- Arm Group Labels: everolimus 1.5 mg, everolimus 3.0 mg
-
- Type: DRUG
- Name: mycophenolate mofetil
- Description: Mycophenolate mofetil supplied as 500 mg tablets.
- Arm Group Labels: mycophenolate mofetil
-
- Type: DRUG
- Name: cyclosporine
- Description: Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
- Arm Group Labels: everolimus 1.5 mg, everolimus 3.0 mg, mycophenolate mofetil
-
- Type: DRUG
- Name: corticosteroids
- Description: Corticosteroids standard dose.
- Arm Group Labels: everolimus 1.5 mg, everolimus 3.0 mg, mycophenolate mofetil
- Novartis Pharmaceuticals