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

Overview

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.

Full Title of Study: “Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2014

Interventions

  • Drug: Febuxostat
    • 80mg PO daily for 8 weeks

Arms, Groups and Cohorts

  • Active Comparator: Febuxostat
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Changes in 24 Hour Blood Pressure
    • Time Frame: 8 weeks
  • Changes in Pulse Wave Velocity
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel O’Connor, UCSD, Principal Investigator, UCSD
    • Jason T. Davis, M.D., Study Director, University of California, San Diego

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