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NCT00037531 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 769
- Enrollment target
NCT00037531: Completed Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00037531 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 769 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
NCT00037531, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 769 participants
- Enrollment target
Study Summary
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled in protocol 0468E1-306-US.
Interventions
- DRUG Sirolimus (RAPAMUNE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 769 participants |
| Est. Completion | 2004-08 |
| Phase | Phase 3 |
What the finished NCT00037531 record still lists
NCT00037531 is an interventional study that assigns participants to a tested intervention. The registered 769 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 1 intervention - of which Sirolimus (RAPAMUNE) is the first listed.
NCT00037531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00037531 about?
NCT00037531 is a clinical study titled "Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients". To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical tr...
What is the current status of trial NCT00037531?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 769 participants. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00037531?
The interventions under investigation include: Sirolimus (RAPAMUNE) (DRUG).
Who is sponsoring clinical trial NCT00037531?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00037531's enrollment target sits among peer trials
769 444th of 2000 higher than 1,556 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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