Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00238446
Collaborator
(none)
Study Details
Study Description
Brief Summary
This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Prospective, Open-label, Multicenter Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Heart Transplant Recipients
Study Start Date
:
Apr 1, 2003
Actual Primary Completion Date
:
Jun 1, 2006
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
Patients who were participating in the core study CERL080A2401 and have successfully completed the first 12 months of the core study
Exclusion Criteria:
Patients who did not complete the 12-month core study CERL080A2401
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00238446
Other Study ID Numbers:
- CERL080A2401E1
First Posted:
Oct 13, 2005
Last Update Posted:
Feb 24, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Novartis Pharmaceuticals