Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

NCT01235910 | Terminated Phase 4 Results

• 1 other identifier: 10-0746
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Cardiac Transplantation

Keywords

Hypertension; Cardiac transplantation; Aliskiren; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)

  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.

  7 days, 14 days, 30 days (End of Study)

Secondary Outcomes (2)

• Aliskiren Plasma Concentrations

  2 weeks

• Blood Pressure

  2 weeks

Study Arms (1)

1

OTHER

Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows

Drug: Aliskiren

Interventions

Aliskiren DRUG

Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows

Also known as: Tekturna (aliskiren), Neoral (cyclosporine)

1

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Heart Association: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Cyclosporine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was stopped due to difficulty finding patients who met the strict inclusion/exclusion criteria. Only one patient was started on study drug.

Results Point of Contact

• Title: Christina Aquilante, Pharm.D.
• Organization: University of Colorado

christina.aquilante@ucdenver.edu

303-724-6126

Study Officials

• Christina L Aquilante, Pharm.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 8, 2010
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 29, 2018
• Results First Posted: August 18, 2015

Record last verified: 2018-05

Locations

US (1)