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NCT00300274 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 721
- Enrollment target
NCT00300274: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00300274 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 721 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00300274, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 721 participants
- Enrollment target
Study 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.
Primary Outcome
Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Ba
Interventions
- DRUG everolimus
- DRUG cyclosporine
- DRUG mycophenolate mofetil
- DRUG corticosteroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 721 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00300274 record still lists
NCT00300274 is an interventional study that assigns participants to a tested intervention. The registered 721 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which everolimus is the first listed.
NCT00300274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00300274 about?
NCT00300274 is a clinical study titled "Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection". 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.
What is the current status of trial NCT00300274?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 721 participants. The study started on 2006-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00300274?
The interventions under investigation include: everolimus (DRUG), cyclosporine (DRUG), mycophenolate mofetil (DRUG), corticosteroids (DRUG).
Who is sponsoring clinical trial NCT00300274?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00300274's enrollment target sits among peer trials
721 494th of 2000 higher than 1,507 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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