Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

This study has been terminated.
(Study was stopped early due to difficulty finding patients who met I/E criteria.)
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01235910
First received: November 3, 2010
Last updated: July 21, 2015
Last verified: July 2015
Results First Received: December 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Cardiac Transplantation
Intervention: Drug: Aliskiren

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aliskiren

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

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


Participant Flow:   Overall Study
    Aliskiren  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aliskiren

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

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


Baseline Measures
    Aliskiren  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  58  (0)  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)   [ Time Frame: 7 days, 14 days, 30 days (End of Study) ]

2.  Secondary:   Aliskiren Plasma Concentrations   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Blood Pressure   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped due to difficulty finding patients who met the strict inclusion/exclusion criteria. Only one patient was started on study drug.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christina Aquilante, Pharm.D.
Organization: University of Colorado
phone: 303-724-6126
e-mail: christina.aquilante@ucdenver.edu


No publications provided


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01235910     History of Changes
Other Study ID Numbers: 10-0746
Study First Received: November 3, 2010
Results First Received: December 10, 2014
Last Updated: July 21, 2015
Health Authority: United States: Food and Drug Administration