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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

Study Description
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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.

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

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Febuxostat
U.S. FDA Resources

Arms and Interventions
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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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, California
Univerisity Of California San Diego
San Diego, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Daniel O'Connor, UCSD UCSD
Study Director: Jason T. Davis, M.D. University of California, San Diego
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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