CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 721 enrolled
Drug / intervention
everolimus +3 moredrug
Likely dose
everolimus 0.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00300274
NCT00300274Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Mar 8, 2006·Updated Aug 16, 2012

In Brief

A Phase 3 clinical trial evaluating everolimus, mycophenolate mofetil, and 2 other interventions for Graft Rejection. Completed, enrolled 721 participants across 64 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Rejection
CountriesArgentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Norway, Puerto Rico, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2006
Enrollment StartJan 1, 2006
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.3 years ago

Interventions

everolimusdrug

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

mycophenolate mofetildrug

Mycophenolate mofetil supplied as 500 mg tablets.

cyclosporinedrug

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

corticosteroidsdrug

Corticosteroids standard dose.