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

February 22, 2017 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

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

Intervention / Treatment

Drug: EC-MPS

Study Type

Interventional

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

October 11, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

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

Other Study ID Numbers

CERL080A2401E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.