Clinical trial
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent…
NCT00300274 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00300274 |
|---|---|
| Title | Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection |
| Official title | 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 |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Graft Rejection |
| Intervention type | Drug |
| Interventions | everolimus, mycophenolate mofetil, cyclosporine, corticosteroids |
| Enrollment | 721 |
| Start date | Jan 1, 2006 |
| Primary completion | Jul 1, 2011 |
| Completion | Jul 1, 2011 |
| First posted | Mar 8, 2006 |
| Last update posted | Aug 16, 2012 |
| Countries | Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Norway, Puerto Rico, Spain and 3 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: