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

This study is currently recruiting participants.
Verified June 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Daniel O'Connor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01472692
First received: November 13, 2011
Last updated: June 22, 2012
Last verified: June 2012
History of Changes

November 13, 2011
June 22, 2012
October 2011
August 2012   (final data collection date for primary outcome measure)
  • Changes in 24 hour blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes in Pulse wave velocity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472692 on ClinicalTrials.gov Archive Site
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Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Prehypertension
  • Gout
  • Pulse Wave Velocity
  • Hypertension
  • 24 Hour Blood Pressure
Drug: Febuxostat
80mg PO daily for 8 weeks
Other Name: Uloric
  • Active Comparator: Febuxostat
    Intervention: Drug: Febuxostat
  • Placebo Comparator: Placebo
    Intervention: Drug: Febuxostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact: Jason T Davis, M.D. 858-534-0639 jtd002@ucsd.edu
Contact: Dalal Naqshbandi 858-534-0639 ucsdbloodpressurestudy@gmail.com
United States
 
NCT01472692
110806
Yes
Daniel O'Connor, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Daniel O'Connor, UCSD UCSD
Study Director: Jason T. Davis, M.D. University of California, San Diego
University of California, San Diego
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP