Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
Phase 4
Completed
- Conditions
- Heart Transplantation
- Interventions
- Registration Number
- NCT00574743
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Enteric-coated Mycophenolate Sodium -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Argentina
🇦🇷Buenos Aires, Argentina
Novartis Investigative
🇨🇦Edmonton, Alberta, Canada
Site 1: X5000BJH
🇦🇷Cordoba, Argentina
Novarits
🇨🇦Ottawa, Canada
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Novartis Investigative site
🇺🇸Los Angeles, California, United States
Novartis
🇨🇦Toronto, Ontario, Canada
Novartis Investigative site, Sydney, Australia
🇦🇺Sydney, Australia
Novartis Pharmaceuticals
🇺🇸Philadelphia, Pennsylvania, United States