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NCT00157014 · ClinicalTrials.gov registry record · Phase 3
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
A Phase 3 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
NCT00157014: Completed Phase 3 study, sponsored by Astellas Pharma.
NCT00157014 is a Phase 3 study that has completed, run by Astellas Pharma. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00157014, a Phase 3 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Primary Outcome
The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase). The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Change is defined as Week 52 assessment- Week 2 assessment.
Interventions
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG Tacrolimus
- DRUG Cyclosporine
- DRUG Mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2004-05-10 |
| Est. Completion | 2008-07-18 |
| Phase | Phase 3 |
What the finished NCT00157014 record still lists
NCT00157014 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT00157014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00157014 about?
NCT00157014 is a clinical study titled "Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens". The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
What is the current status of trial NCT00157014?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2004-05-10. Estimated completion is 2008-07-18.
What interventions are being tested in trial NCT00157014?
The interventions under investigation include: Prednisone (DRUG), Methylprednisolone (DRUG), Tacrolimus (DRUG), Cyclosporine (DRUG), Mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00157014?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00157014's enrollment target sits among peer trials
111 1655th of 2000 higher than 344 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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