Status:
COMPLETED
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Graft Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 rec...
Eligibility Criteria
Inclusion
- Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
- The graft must be functional at time of randomization.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
721 Patients enrolled
Trial Details
Trial ID
NCT00300274
Start Date
January 1 2006
End Date
July 1 2011
Last Update
August 16 2012
Active Locations (64)
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1
UCLA Medical Center
Los Angeles, California, United States
2
California Pacific Medical Center
San Francisco, California, United States
3
Stanford U Sch, Falk Cardiovasular Research Ctr.
Stanford, California, United States
4
University of Florida Shands Hospital
Gainesville, Florida, United States