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

NCT ID: NCT00238446

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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EC-MPS

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

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CERL080A2401E1

Identifier Type: -

Identifier Source: org_study_id

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