Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
Completed · Phase 4
Conditions studied: Heart Transplantation
In brief
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
Key facts
- Study ID
- NCT00574743
- Run by
- Novartis Pharmaceuticals
- People needed
- 162
- Starts
- 2002-01-01
- Last updated by the study team
- 2011-11-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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