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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00574743 |
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
Condition | Intervention | Phase |
---|---|---|
Heart Transplantation |
Drug: Enteric-coated Mycophenolate Sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 162 |
Study Start Date: | January 2002 |
Arms | Assigned Interventions |
---|---|
2: No Intervention | |
1: Active Comparator | Drug: Enteric-coated Mycophenolate Sodium |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
United States, California | |
Novartis Investigative site | |
Los Angeles, California, United States, 90073 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Pennsylvania | |
Novartis Pharmaceuticals | |
Philadelphia, Pennsylvania, United States, 19103 | |
Argentina | |
Argentina | |
Buenos Aires, Argentina, 1107 | |
Site 1: X5000BJH | |
Cordoba, Argentina | |
Australia | |
Novartis Investigative site, Sydney, Australia | |
Sydney, Australia | |
Canada | |
Novarits | |
ottawa, Canada, K1H 8L6 | |
Canada, Alberta | |
Novartis Investigative | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, Ontario | |
Novartis | |
Toronto, Ontario, Canada, M5G 2C4 |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CERL080A2401 |
Study First Received: | December 14, 2007 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00574743 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; United States: Food and Drug Administration; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board |
ERL080A, Heart Transplantation, Mycophenolate, EC-MPS |
Mycophenolate mofetil Mycophenolic Acid |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |