NCT00238446

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

October 11, 2005

Last Update Submit

February 22, 2017

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

Interventions

EC-MPSDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were participating in the core study CERL080A2401 and have successfully completed the first 12 months of the core study

You may not qualify if:

  • Patients who did not complete the 12-month core study CERL080A2401

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

April 1, 2003

Primary Completion

June 1, 2006

Last Updated

February 24, 2017

Record last verified: 2017-02