Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
NCT ID: NCT00574743
Last Updated: 2011-11-02
Study Results
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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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2002-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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2
No interventions assigned to this group
1
Enteric-coated Mycophenolate Sodium
Interventions
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Enteric-coated Mycophenolate Sodium
Eligibility Criteria
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Inclusion Criteria
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Exclusion Criteria
* Patients on Left Ventricular Assist Device who have received any immunotherapy prior to transplantation or who are scheduled to receive immunotherapy thereafter.
* Patients with Panel Reactive Antibodies (PRA) 25%.
* Patients with serum creatinine 3.0mg/dL..
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
* Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low aspirin treatment is allowed).
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
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Novartis Investigative site
Los Angeles, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Novartis Pharmaceuticals
Philadelphia, Pennsylvania, United States
Argentina
Buenos Aires, , Argentina
Site 1: X5000BJH
Córdoba, , Argentina
Novartis Investigative site, Sydney, Australia
Sydney, , Australia
Novartis Investigative
Edmonton, Alberta, Canada
Novartis
Toronto, Ontario, Canada
Novarits
Ottawa, , Canada
Countries
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Other Identifiers
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CERL080A2401
Identifier Type: -
Identifier Source: org_study_id