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

Phase 4

Completed

• Conditions: 24 Hour Blood Pressure; Prehypertension; Gout; Pulse Wave Velocity; Hypertension
• Interventions: Drug: Febuxostat

• Registration Number: NCT01472692
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-13
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2019-11
• Results First Submitted: 2019-11-26
• Results First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Results First Posted: 2019-12-16
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Febuxostat	Febuxostat	-
Placebo	Febuxostat	-

Primary Outcome Measures

Name	Time	Method
Changes in Pulse Wave Velocity	8 weeks
Changes in 24 Hour Blood Pressure	8 weeks

Trial Locations

Locations (1)

Univerisity Of California San Diego; 🇺🇸 San Diego, California, United States