drugset / Trial / NCT00149929

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

NCT00149929

Phase 3 Completed 246 enrolled Novartis
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.

Timeline

Start
1999-12
Primary completion
2003-04
Completion
2003-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Sodium Unknown

Indications

No indication recorded.