Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00574743
First received: December 14, 2007
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 162
Study Start Date: January 2002
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Active Comparator: 1 Drug: Enteric-coated Mycophenolate Sodium

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574743

Locations
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, Alberta
Novartis Investigative
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Novartis
Toronto, Ontario, Canada, M5G 2C4
Canada
Novarits
Ottawa, Canada, K1H 8L6
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00574743     History of Changes
Other Study ID Numbers: CERL080A2401
Study First Received: December 14, 2007
Last Updated: November 1, 2011
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

Keywords provided by Novartis:
ERL080A, Heart Transplantation, Mycophenolate, EC-MPS

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014