Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01328769
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Paul N. Hopkins, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Hypertension
Interventions Drug: Febuxostat
Drug: Placebo
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description 80mg once daily Matching placebo dose 80mg once daily
Period Title: Overall Study
Started 25 24
Completed 25 23
Not Completed 0 1
Arm/Group Title Febuxostat Placebo Total
Hide Arm/Group Description 80mg daily Matching placebo dose 80mg once daily Total of all reporting groups
Overall Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 23 participants 48 participants
50.6  (8.1) 48.6  (8.0) 49.6  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
4
  16.0%
4
  17.4%
8
  16.7%
Male
21
  84.0%
19
  82.6%
40
  83.3%
1.Primary Outcome
Title Change in Renal Plasma Flow in Response to Infused Angiotensin II
Hide Description [Not Specified]
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
80mg daily
Matching placebo dose 80mg once daily
Overall Number of Participants Analyzed 25 23
Mean (Standard Error)
Unit of Measure: ml/minute
-54.1  (13.4) -10.8  (14)
2.Secondary Outcome
Title Change in Endothelial Function
Hide Description Endothelial function was calculated by software from the manufacturer VENDYS. The measurement was taken by using the index of area under the curve of the finger temperature recovery curve just after releasing a blood pressure cuff. The blood pressure cuff occluded blood flow for 5 minutes as compared to the temperature curve in the non-occluded arm.
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
80mg daily
Matching placebo dose 80mg once daily
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ratio of finger temperature
1.66  (0.63) 1.90  (0.39)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Febuxostat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Febuxostat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
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
Responsible Party: Paul N. Hopkins, University of Utah
ClinicalTrials.gov Identifier: NCT01328769     History of Changes
Other Study ID Numbers: 42916
First Submitted: March 29, 2011
First Posted: April 5, 2011
Results First Submitted: July 7, 2015
Results First Posted: September 17, 2015
Last Update Posted: September 17, 2015