Phase 4
N=47
Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Prehypertension · Gout · Pulse Wave Velocity · Hypertension · 24 Hour Blood Pressure
Bottom Line
View on ClinicalTrials.gov: NCT01472692 ↗Enrolled (actual)
47
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Changes in 24 Hour Blood Pressure
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Febuxostat (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in 24 Hour Blood Pressure |
— | — |
| PRIMARY Changes in Pulse Wave Velocity |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01472692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.