Trials / Completed
CompletedNCT00149864
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Maintenance Renal Transplant Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
Summary
Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mycophenolate sodium (enteric coated) |
Timeline
- Start date
- 2000-02-01
- Primary completion
- 2003-12-01
- Completion
- 2003-12-01
- First posted
- 2005-09-08
- Last updated
- 2011-02-02
Source: ClinicalTrials.gov record NCT00149864. Inclusion in this directory is not an endorsement.