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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

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.