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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
Sponsor:
Information provided by (Responsible Party):
Daniel O'Connor, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE November 13, 2011
First Posted Date  ICMJE November 16, 2011
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2011)
  • Changes in 24 hour blood pressure [ Time Frame: 8 weeks ]
  • Changes in Pulse wave velocity [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01472692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Official Title  ICMJE Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Prehypertension
  • Gout
  • Pulse Wave Velocity
  • Hypertension
  • 24 Hour Blood Pressure
Intervention  ICMJE Drug: Febuxostat
80mg PO daily for 8 weeks
Other Name: Uloric
Study Arms  ICMJE
  • Active Comparator: Febuxostat
    Intervention: Drug: Febuxostat
  • Placebo Comparator: Placebo
    Intervention: Drug: Febuxostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2014)
47
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2011)
50
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01472692
Other Study ID Numbers  ICMJE 110806
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel O'Connor, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel O'Connor, UCSD UCSD
Study Director: Jason T. Davis, M.D. University of California, San Diego
PRS Account University of California, San Diego
Verification Date March 2014

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