drugset / Trial / NCT00300274

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

NCT00300274

Phase 3 Completed 721 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-01
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide
Subject Everolimus Small molecule 0.75 mg
Subject Everolimus Small molecule 1.5 mg
Comparator Mycophenolate Mofetil Small molecule 1500 mg

Indications