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Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure

This study has been completed.
Information provided by (Responsible Party):
Daniel O'Connor, University of California, San Diego Identifier:
First received: November 13, 2011
Last updated: March 31, 2014
Last verified: March 2014
High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.

Condition Intervention Phase
Prehypertension Gout Pulse Wave Velocity Hypertension 24 Hour Blood Pressure Drug: Febuxostat Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Daniel O'Connor, University of California, San Diego:

Primary Outcome Measures:
  • Changes in 24 hour blood pressure [ Time Frame: 8 weeks ]
  • Changes in Pulse wave velocity [ Time Frame: 8 weeks ]

Enrollment: 47
Study Start Date: October 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01472692

United States, California
Univerisity Of California San Diego
San Diego, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Daniel O'Connor, UCSD UCSD
Study Director: Jason T. Davis, M.D. University of California, San Diego
  More Information

Responsible Party: Daniel O'Connor, M.D. Professor of Medicine, University of California, San Diego Identifier: NCT01472692     History of Changes
Other Study ID Numbers: 110806
Study First Received: November 13, 2011
Last Updated: March 31, 2014

Keywords provided by Daniel O'Connor, University of California, San Diego:
Puls Wave Velocity
24 hour blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Gout Suppressants
Antirheumatic Agents processed this record on September 21, 2017