- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574743
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
November 1, 2011 updated by: Novartis Pharmaceuticals
A 12-month, Single-blind, Randomized, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of ERL080A Compared With MMF in de Novo Heart Recipients
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1107
- Argentina
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Cordoba, Argentina
- Site 1: X5000BJH
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Sydney, Australia
- Novartis Investigative site, Sydney, Australia
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Ottawa, Canada, K1H 8L6
- Novarits
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Novartis Investigative
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Novartis
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California
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Los Angeles, California, United States, 90073
- Novartis Investigative Site
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Novartis Pharmaceuticals
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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
- Male or female cardiac patients 18-65 years old undergoing primary heart transplantation treated with CS-ME and corticosteroids as basic immunosuppression.
- 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 with donor hearts greater than 60 years of age and/or with cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary disease or are known to have heart disease at time of transplant.
- 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).
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 1
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No Intervention: 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2002
Primary Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Estimate)
November 2, 2011
Last Update Submitted That Met QC Criteria
November 1, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERL080A2401
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.
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Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
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The Hospital for Sick ChildrenCompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCanada
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Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationSpain, Australia, France, Germany, Canada, Italy, United Kingdom, Belgium, South Africa, Switzerland, Sweden, United States, Austria, Brazil, Czechia, Denmark, Finland, Hungary, Ireland, Mexico, Netherlands, New Zealand, Poland
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Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
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Emory UniversityCompletedLiver Transplantation | Kidney Transplantation | Heart Transplantation | Lung Transplantation | Heart-Lung TransplantationUnited States
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Astellas Pharma IncCompletedHeart Transplantation | Lung Transplantation | Pancreas (Including SPK) TransplantationFrance, United Kingdom, Taiwan, Belgium, Italy, Austria
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National Taiwan University HospitalNational Science Council, TaiwanUnknownLiver Transplantation | Heart TransplantationTaiwan
-
University of Oslo School of PharmacyCompletedHeart Transplantation | Renal TransplantationNorway
Clinical Trials on Enteric-coated Mycophenolate Sodium
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Sihuan Pharmaceutical Holdings Group Ltd.Unknown
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Sihuan Pharmaceutical Holdings Group Ltd.Completed
-
Guangzhou Yipinhong Pharmaceutical CO.,LTDCompletedChronic Hepatitis BChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Unknown
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Completed
-
Guangzhou Yipinhong Pharmaceutical CO.,LTDCompleted
-
Novartis PharmaceuticalsCompletedRenal TransplantationUnited States
-
University of PennsylvaniaNovartis PharmaceuticalsTerminatedTransplants and ImplantsUnited States
-
NovartisCompletedMaintenance Kidney TransplantSwitzerland
-
Guangzhou Yipinhong Pharmaceutical CO.,LTDUnknown