NCT00300274

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 721 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Rejection

Interventions

Type	Name	Description
DRUG	everolimus	Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
DRUG	mycophenolate mofetil	Mycophenolate mofetil supplied as 500 mg tablets.
DRUG	cyclosporine	Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
DRUG	corticosteroids	Corticosteroids standard dose.

Timeline

• Start date: 2006-01-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2006-03-08
• Last updated: 2012-08-16
• Results posted: 2012-08-16

Locations

64 sites across 15 countries: United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Norway, Puerto Rico, Spain, Taiwan, United Kingdom