Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: American Heart Association
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• 6 months or more since cardiac transplant

• Clinically stable from a transplant perspective

• Maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid

• Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate measurements, spaced 2 minutes apart.

Exclusion Criteria:

• Clinical instability from a cardiac transplant perspective

• Contraindications to aliskiren therapy

• Conditions that may increase the risk of aliskiren adverse effects

• Severe hypertension

• Concomitant medications known to increase or decrease aliskiren plasma exposure.