Trials / Completed
CompletedNCT01017029
Everolimus in de Novo Heart Transplant Recipients
Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 182 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus | |
| DRUG | Mycophenolate mofetil + Everolimus |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2009-11-20
- Last updated
- 2015-01-12
- Results posted
- 2014-12-18
Locations
12 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT01017029. Inclusion in this directory is not an endorsement.