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

This study has been completed.
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: March 31, 2014
Last verified: March 2014
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]
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

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 13, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Prehypertension
Gout
Puls Wave Velocity
Hypertension
24 hour blood pressure

Additional relevant MeSH terms:
Prehypertension
Cardiovascular Diseases
Vascular Diseases
Febuxostat
 Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015