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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01472692
Other study ID # 110806
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2011
Est. completion date March 2014

Study information

Verified date November 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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


Intervention

Drug:
Febuxostat
80mg PO daily for 8 weeks

Locations

Country Name City State
United States Univerisity Of California San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in 24 Hour Blood Pressure 8 weeks
Primary Changes in Pulse Wave Velocity 8 weeks
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