Clinical trial
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients…
NCT00189826 · Astellas Pharma Inc, Industry · Completed
Key facts
| NCT number | NCT00189826 |
|---|---|
| Title | A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation. |
| Official title | A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation |
| Lead sponsor | Astellas Pharma Inc, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Liver Transplantation |
| Intervention type | Drug |
| Interventions | tacrolimus |
| Enrollment | 475 |
| Start date | Aug 1, 2004 |
| Primary completion | Dec 1, 2006 |
| Completion | Dec 1, 2006 |
| First posted | Sep 19, 2005 |
| Last update posted | Jul 9, 2014 |
| Countries | Australia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Ireland, Italy, Norway, Poland and 4 more |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: