Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
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ClinicalTrials.gov Identifier: NCT01472692 |
Recruitment Status
:
Completed
First Posted
: November 16, 2011
Last Update Posted
: April 2, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prehypertension Gout Pulse Wave Velocity Hypertension 24 Hour Blood Pressure | Drug: Febuxostat | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Febuxostat |
Drug: Febuxostat
80mg PO daily for 8 weeks
Other Name: Uloric
|
Placebo Comparator: Placebo |
Drug: Febuxostat
80mg PO daily for 8 weeks
Other Name: Uloric
|
- Changes in 24 hour blood pressure [ Time Frame: 8 weeks ]
- Changes in Pulse wave velocity [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP).
- Plasma uric acid level ≥5 mg/dl
- Ages 18-50
- non-smokers
- Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.
Exclusion Criteria:
- no current smoking in the prior 6 months.
- Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study.
- Any history of gout, hypertension, hypercholesterolemia, morbid obesity.
- Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications
- any history of illicit drug use within the last 6 months

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): NCT01472692
United States, California | |
Univerisity Of California San Diego | |
San Diego, California, United States, 92037 |
Principal Investigator: | Daniel O'Connor, UCSD | UCSD | |
Study Director: | Jason T. Davis, M.D. | University of California, San Diego |
Responsible Party: | Daniel O'Connor, M.D. Professor of Medicine, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01472692 History of Changes |
Other Study ID Numbers: |
110806 |
First Posted: | November 16, 2011 Key Record Dates |
Last Update Posted: | April 2, 2014 |
Last Verified: | March 2014 |
Keywords provided by Daniel O'Connor, University of California, San Diego:
Prehypertension Gout Puls Wave Velocity Hypertension 24 hour blood pressure |
Additional relevant MeSH terms:
Hypertension Prehypertension Vascular Diseases Cardiovascular Diseases |
Febuxostat Gout Suppressants Antirheumatic Agents |