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

Novartis

Status and phase: Completed; Phase 3

Conditions: 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

Treatments: Drug: EC-MPS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00238446

CERL080A2401E1

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)