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Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection


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.

Study Status: Completed


Condition Intervention Phase
Graft Rejection Drug: everolimus
Drug: mycophenolate mofetil
Drug: cyclosporine
Drug: corticosteroids
Phase 3

Verified by Novartis Pharmaceuticals July, 2012

Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis identifier: NCT00300274

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio
United States

Novartis., Study Director

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