Efficacy and Safety of Enteric-Coated Mycophenolate Sodium in Heart Transplant Recipients

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00238446

Purpose

This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.

Condition	Intervention	Phase
Patients Successfully Completing the 12-Month Treatment Period of the Core Study (de Novo Heart Recipients) Who Were Interested of Being Treated With EC-MPS	Drug: EC-MPS	Phase III

MedlinePlus related topics: Dietary Sodium Heart Transplantation

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Study Start Date:	April 2003
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238446

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	CERL080A2401E1
Study First Received:	October 11, 2005
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00238446
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Enteric-coated mycophenolate sodium, heart transplant recipients, long term safety

Study placed in the following topic categories:

Mycophenolate mofetil

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009