drugset / Trial / NCT00157014
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Timeline
- Start
- 2004-05-10
- Primary completion
- 2008-07-18
- Completion
- 2008-07-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 3 mg/kg | Oral |
| Comparator | Cyclosporine | Peptide | 5 mg/kg | Oral |
| Comparator | Cyclosporine | Peptide | 6 mg/kg | Oral |
| Comparator | Cyclosporine | Peptide | 10 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.3 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |