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Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma Canada, Inc. |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00157014 |
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Condition | Intervention | Phase |
---|---|---|
Heart Transplantation Heart Diseases |
Drug: Tacrolimus Drug: cyclosporin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM |
Enrollment: | 112 |
Study Start Date: | July 2004 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Tacrolimus
Oral
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2: Active Comparator |
Drug: cyclosporin
Oral
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Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporin as their primary immunosuppressant
Two parallel active arms.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients having any one of the following at enrolment:
United States, California | |
Los Angeles, California, United States, 90095 | |
Canada, Alberta | |
Calgary, Alberta, Canada, T2N 2T9 | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Edmonton, Alberta, Canada, T6G 2 N8 | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Canada, Ontario | |
Ottawa, Ontario, Canada, K1Y 4W7 | |
London, Ontario, Canada, N6A 5A5 | |
Toronto, Ontario, Canada, M5G 2N2 | |
Toronto, Ontario, Canada, M5G 1X8 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H3A 1A1 | |
Montreal, Quebec, Canada, H1T 1C8 | |
Sainte-Foy, Quebec, Canada, G1V 4G5 |
Study Director: | Medical Monitor | Astellas Pharma Canada, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | FKC-009 |
Study First Received: | September 8, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00157014 History of Changes |
Health Authority: | Canada: Health Canada |
Treatment Outcome Treatment Effectiveness Anti-rejection therapy Immunosuppression Antirejection |
Cyclosporine Heart Diseases Immunologic Factors Clotrimazole Miconazole Antifungal Agents |
Tioconazole Stress Tacrolimus Antirheumatic Agents Immunosuppressive Agents Cyclosporins |
Anti-Infective Agents Heart Diseases Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Tacrolimus |
Cyclosporins Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Antifungal Agents Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents |