Status:
COMPLETED
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart and Lung Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retr...
Eligibility Criteria
Inclusion
- Patients receiving a first heart or bilateral or single lung transplant
- Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.
Exclusion
- Multi-organ transplants or previously transplanted organs
- Patients with the need of more than two cyclosporine microemulsion dosages per day
- Other protocol-defined inclusion/exclusion criteria may applied
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00154193
Start Date
June 1 2004
Last Update
February 11 2020
Active Locations (1)
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1
Novartis
Basel, Switzerland