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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00574743
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.

Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: Enteric-coated Mycophenolate Sodium Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : January 2002
Actual Primary Completion Date : April 2004

Arm Intervention/treatment
No Intervention: 2
Active Comparator: 1 Drug: Enteric-coated Mycophenolate Sodium

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00574743

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
Buenos Aires, Argentina, 1107
Site 1: X5000BJH
Cordoba, Argentina
Novartis Investigative site, Sydney, Australia
Sydney, Australia
Canada, Alberta
Novartis Investigative
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Ottawa, Canada, K1H 8L6
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00574743     History of Changes
Other Study ID Numbers: CERL080A2401
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action