Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prehypertension; Gout; Pulse Wave Velocity; Hypertension; 24 Hour Blood Pressure
Intervention: Febuxostat (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Daniel O'Connor, UCSD, Principal Investigator, Affiliation: UCSD
Jason T. Davis, M.D., Study Director, Affiliation: University of California, San Diego
Overall contact:
Jason T Davis, M.D., Phone: 858-534-0639, Email: jtd002@ucsd.edu
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.
Clinical Details
Official title: Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Changes in 24 hour blood pressureChanges in Pulse wave velocity
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Jason T Davis, M.D., Phone: 858-534-0639, Email: jtd002@ucsd.edu
Univerisity Of California San Diego, San Diego, California 92037, United States; Recruiting
Jason T Davis, M.D, Phone: 858-534-0639, Email: ucsdbloodpressurestudy@gmail.com
Dalal Naqshbandi, Phone: 858-534-0639, Email: ucsdbloodpressurestudy@gmail.com
Daniel O'Connor, MD, Principal Investigator
Jason Davis, M.D., Sub-Investigator
Fangwen Rao, MD, Sub-Investigator
Dalal Naqshbandi, Sub-Investigator
Additional Information
Starting date: October 2011
Last updated: June 22, 2012
|
