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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 5, 2011
Last Update Posted: September 17, 2015
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.
Information provided by (Responsible Party):
Paul N. Hopkins, University of Utah
In this study the investigators will recruit hypertensive subjects with higher than average uric acid levels to test the effect of lowering uric acid with febuxostat on several measures as listed below. This will be a randomized, double-blind, placebo-controlled, parallel group study.

Condition Intervention Phase
Hypertension Drug: Febuxostat Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)

Resource links provided by NLM:

Further study details as provided by Paul N. Hopkins, University of Utah:

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

Secondary Outcome Measures:
  • Change in Endothelial Function [ Time Frame: Baseline to 6 weeks ]
    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.

Enrollment: 49
Study Start Date: March 2011
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Febuxostat
Drug: Febuxostat
Placebo Comparator: Placebo
Drug: Placebo

  Show Detailed Description


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mild to moderate hypertension. For purposes of this study, the investigators define mild to moderate hypertension as being on no more than 1-2 antihypertensive medications and blood pressure <140 mm Hg systolic and <90 mm Hg diastolic based on mean seated blood pressure at the screening visit in our clinic. For these visits, the investigators measure blood pressure using a Dinamap automatic oscillometric cuff while subjects are seated quietly. The subjects are left in a quiet room without speaking for 5 minutes initially. The Dinamap is started and the technician leaves the room and 3 blood pressures are obtained at intervals of 2 minutes. The investigators use the mean of last 2 blood pressures for classification purposes. This is the approach the investigators have used in several multicenter studies including HyperGEN and the NHLBI Family Heart Study.
  • Age 18 to 60.
  • Uric acid =5.8 mg/dl. This was the mean uric acid among hypertensives in our prior study.11 As renal plasma flow response to Ang II infusion decreased linearly with higher uric acid, the investigators felt that using higher than average uric acid will provide greater power.

Exclusion Criteria:

  • Severe or poorly controlled hypertension (treated blood pressure >160 mm Hg systolic or >100 mm Hg diastolic).
  • Diabetes (type 1 or type 2).
  • Estimated GFR <60 ml/min.
  • Persons unable stop all medications (including antihypertensives) other than stable doses of thyroxine or estrogen for at least 2 weeks.
  • Secondary hypertension.
  • Prior history of clinically diagnosed coronary artery disease or congestive heart failure.
  • Taking uric acid lowering medication within 1 month of screening visit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328769

United States, Utah
Cardiovascular Genetics, University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Paul N. Hopkins
Principal Investigator: Paul N Hopkins Cardiovascular Genetics
  More Information

Responsible Party: Paul N. Hopkins, Professor of Internal Medicine, 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
Last Verified: July 2015

Keywords provided by Paul N. Hopkins, University of Utah:
uric acid
intra-renal renin-angiotensin system
renal plasma flow
angiotensin II

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Gout Suppressants
Antirheumatic Agents