Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00149864|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Mycophenolate sodium (enteric coated)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Maintenance Renal Transplant Patients|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||December 2003|
|Actual Study Completion Date :||December 2003|
- To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.
- Safety/efficacy based on adverse event (AE) reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149864