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

NCT ID: NCT01472692

Last Updated: 2019-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Prehypertension Gout Pulse Wave Velocity Hypertension 24 Hour Blood Pressure

Keywords

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Prehypertension Gout Puls Wave Velocity Hypertension 24 hour blood pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Febuxostat

Group Type ACTIVE_COMPARATOR

Febuxostat

Intervention Type DRUG

80mg PO daily for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Febuxostat

Intervention Type DRUG

80mg PO daily for 8 weeks

Interventions

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Febuxostat

80mg PO daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Uloric

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel O'Connor, UCSD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Jason T. Davis, M.D.

Role: STUDY_DIRECTOR

University of California, San Diego

Locations

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Univerisity Of California San Diego

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32877573 (View on PubMed)

Other Identifiers

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110806

Identifier Type: -

Identifier Source: org_study_id