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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00037531
The ClinicalTrials.gov registry entry for NCT00037531 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 769 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sirolimus (RAPAMUNE) is the first listed.
NCT00037531 reports 0 study locations.
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.
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