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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT01472692
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prehypertension; Gout; Pulse Wave Velocity; Hypertension; 24 Hour Blood Pressure	Drug: Febuxostat	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Febuxostat	Drug: Febuxostat; 80mg PO daily for 8 weeks; Other Names: Uloric
Placebo Comparator: Placebo	Drug: Febuxostat; 80mg PO daily for 8 weeks; Other Names: Uloric

Outcome Measures

Primary Outcome Measures

1. Changes in 24 Hour Blood Pressure [8 weeks]

2. Changes in Pulse Wave Velocity [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01472692
• Other Study ID Numbers: 110806
• First Posted: Nov 16, 2011
• Last Update Posted: Dec 16, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by University of California, San Diego: Prehypertension; Gout; Puls Wave Velocity; Hypertension; 24 hour blood pressure
• Additional relevant MeSH terms: Hypertension; Prehypertension; Febuxostat

Study Results

Participant Flow

Pre-assignment Detail	The Principal Investigator for this study has passed away and the results data is not available.

Arm/Group Title	Febuxostat	Placebo
Arm/Group Description	Febuxostat: 80mg PO daily for 8 weeks	Febuxostat: 80mg PO daily for 8 weeks
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Febuxostat	Placebo	Total
Arm/Group Description	Febuxostat: 80mg PO daily for 8 weeks	Febuxostat: 80mg PO daily for 8 weeks	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Changes in 24 Hour Blood Pressure
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The Principal Investigator for this study has passed away and the results data is not available.

Arm/Group Title	Febuxostat	Placebo
Arm/Group Description	Febuxostat: 80mg PO daily for 8 weeks	Febuxostat: 80mg PO daily for 8 weeks
Measure Participants	0	0

2. Primary Outcome

Title	Changes in Pulse Wave Velocity
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The Principal Investigator for this study has passed away and the results data is not available.

Arm/Group Title	Febuxostat	Placebo
Arm/Group Description	Febuxostat: 80mg PO daily for 8 weeks	Febuxostat: 80mg PO daily for 8 weeks
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	The Principal Investigator for this study has passed away and the results data is not available.
Arm/Group Title	Febuxostat		Placebo
Arm/Group Description	Febuxostat: 80mg PO daily for 8 weeks		Febuxostat: 80mg PO daily for 8 weeks
All Cause Mortality
	Febuxostat		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Febuxostat		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Febuxostat		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The Principal Investigator for this study has passed away and the results data is not available.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.