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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 11, 2005
Last updated: February 22, 2017
Last verified: February 2017
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Study Start Date: April 2003
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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.

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Please refer to this study by its identifier: NCT00238446

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00238446     History of Changes
Other Study ID Numbers: CERL080A2401E1
Study First Received: October 11, 2005
Last Updated: February 22, 2017

Keywords provided by Novartis:
Enteric-coated mycophenolate sodium, heart transplant recipients, long term safety

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017