drugset
drugset / Trial / NCT00149864

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

NCT00149864 ↗

Phase 3 Completed 264 enrolled Novartis
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-02
Primary completion
2003-12
Completion
2003-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Sodium Unknown 720 mg —

Indications

No indication recorded.