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NCT00574197 · ClinicalTrials.gov registry record · Phase 4
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT00574197: Completed Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT00574197 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00574197, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.
Primary Outcome
Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale) GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort.
Interventions
- DRUG Mycophenolate Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00574197 record still lists
NCT00574197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate Sodium is the first listed.
NCT00574197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00574197 about?
NCT00574197 is a clinical study titled "Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients". Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-c...
What is the current status of trial NCT00574197?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2006-06. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00574197?
The interventions under investigation include: Mycophenolate Sodium (DRUG).
Who is sponsoring clinical trial NCT00574197?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00574197's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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