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

Hypertension Clinical Trial

Official title:

Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472692
• Other study ID #: 110806
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• 24 Hour Blood Pressure
• Gout
• Hypertension
• Prehypertension
• Pulse Wave Velocity

Intervention

Drug:
• Febuxostat
80mg PO daily for 8 weeks

Locations

Country	Name	City	State
United States	Univerisity Of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 24 Hour Blood Pressure		8 weeks
Primary	Changes in Pulse Wave Velocity		8 weeks