Clinical trial
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in…
NCT00400400 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00400400 |
|---|---|
| Title | Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance |
| Official title | A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Renal Transplantation |
| Intervention type | Drug |
| Interventions | Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil, Placebo to mycophenolate sodium, Placebo to mycophenolate mofetil |
| Enrollment | 400 |
| Start date | Oct 1, 2006 |
| Primary completion | Jun 1, 2008 |
| First posted | Nov 16, 2006 |
| Last update posted | Aug 15, 2011 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes 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: