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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238446

Enrollment

Unknown

Registered

2005-10-13

Start date

2003-04-30

Completion date

Unknown

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Keywords

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

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.

Interventions

DRUGEC-MPS

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026