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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Daniel O'Connor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT01472692

First received: November 13, 2011

Last updated: March 31, 2014

Last verified: March 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Prehypertension Gout Pulse Wave Velocity Hypertension 24 Hour Blood Pressure	Drug: Febuxostat	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive

Resource links provided by NLM:

Drug Information available for: Febuxostat

U.S. FDA Resources

Further study details as provided by Daniel O'Connor, University of California, San Diego:

Primary Outcome Measures:

Changes in 24 hour blood pressure [ Time Frame: 8 weeks ]
Changes in Pulse wave velocity [ Time Frame: 8 weeks ]


Enrollment:	47
Study Start Date:	October 2011
Study Completion Date:	March 2014
Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Febuxostat	Drug: Febuxostat 80mg PO daily for 8 weeks Other Name: Uloric
Placebo Comparator: Placebo	Drug: Febuxostat 80mg PO daily for 8 weeks Other Name: Uloric

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472692

Locations


United States, California
Univerisity Of California San Diego
San Diego, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Investigators


Principal Investigator:	Daniel O'Connor, UCSD	UCSD
Study Director:	Jason T. Davis, M.D.	University of California, San Diego

More Information


Responsible Party:	Daniel O'Connor, M.D. Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT01472692 History of Changes
Other Study ID Numbers:	110806
Study First Received:	November 13, 2011
Last Updated:	March 31, 2014

Keywords provided by Daniel O'Connor, University of California, San Diego:


Prehypertension Gout Puls Wave Velocity Hypertension 24 hour blood pressure

Additional relevant MeSH terms:


Hypertension Prehypertension Vascular Diseases Cardiovascular Diseases	Febuxostat Gout Suppressants Antirheumatic Agents

ClinicalTrials.gov processed this record on August 23, 2017

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