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Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation
The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. In terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.
Details
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | 2011-05 |
| Completion | 2012-12 |
Conditions
- Hypertension
- Cardiac Transplantation
Interventions
- Aliskiren
Primary outcomes
- Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC) — 7 days, 14 days, 30 days (End of Study)
The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.
Countries
United States