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Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul N. Hopkins, University of Utah
ClinicalTrials.gov Identifier:
NCT01328769
First received: March 29, 2011
Last updated: August 13, 2015
Last verified: July 2015
Results First Received: July 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Hypertension
Interventions: Drug: Febuxostat
Drug: Placebo

  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
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Reporting Groups
  Description
Febuxostat 80mg once daily
Placebo Matching placebo dose 80mg once daily

Participant Flow:   Overall Study
    Febuxostat   Placebo
STARTED   25   24 
COMPLETED   25   23 
NOT COMPLETED   0   1 



  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.
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Reporting Groups
  Description
Febuxostat 80mg daily
Placebo Matching placebo dose 80mg once daily
Total Total of all reporting groups

Baseline Measures
   Febuxostat   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   23   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.6  (8.1)   48.6  (8.0)   49.6  (8.1) 
Gender 
[Units: Participants]
     
Female   4   4   8 
Male   21   19   40 


  Outcome Measures
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1.  Primary:   Change in Renal Plasma Flow in Response to Infused Angiotensin II   [ Time Frame: Baseline to 6 weeks ]

2.  Secondary:   Change in Endothelial Function   [ Time Frame: Baseline to 6 weeks ]


  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
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  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: Paul Hopkins
Organization: University of Utah
phone: 801-585-8139
e-mail: paul.hopkins@utah.edu



Responsible Party: Paul N. Hopkins, University of Utah
ClinicalTrials.gov Identifier: NCT01328769     History of Changes
Other Study ID Numbers: 42916
Study First Received: March 29, 2011
Results First Received: July 7, 2015
Last Updated: August 13, 2015
Health Authority: United States: Institutional Review Board