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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00238446
First received: October 11, 2005
Last updated: November 1, 2011
Last verified: November 2011

October 11, 2005
November 1, 2011
April 2003
June 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00238446 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients
A Prospective, Open-label, Multicenter Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Heart Transplant Recipients

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

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2006   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00238446
CERL080A2401E1
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Study Director: Novartis Novartis
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP