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

Primary Purpose

Prehypertension, Gout, Pulse Wave Velocity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Febuxostat
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring Prehypertension, Gout, Puls Wave Velocity, Hypertension, 24 hour blood pressure

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Univerisity Of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Febuxostat

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in 24 Hour Blood Pressure
Changes in Pulse Wave Velocity

Secondary Outcome Measures

Full Information

First Posted
November 13, 2011
Last Updated
November 26, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01472692
Brief Title
Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Official Title
Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Gout, Pulse Wave Velocity, Hypertension, 24 Hour Blood Pressure
Keywords
Prehypertension, Gout, Puls Wave Velocity, Hypertension, 24 hour blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Febuxostat
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
Uloric
Intervention Description
80mg PO daily for 8 weeks
Primary Outcome Measure Information:
Title
Changes in 24 Hour Blood Pressure
Time Frame
8 weeks
Title
Changes in Pulse Wave Velocity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel O'Connor, UCSD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason T. Davis, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Study Director
Facility Information:
Facility Name
Univerisity Of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32877573
Citation
Gois PHF, Souza ERM. Pharmacotherapy for hyperuricaemia in hypertensive patients. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD008652. doi: 10.1002/14651858.CD008652.pub4.
Results Reference
derived

Learn more about this trial

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

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