PrehypertensionPhase 4NCT01472692

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

A Phase 4 study testing Febuxostat in people with Prehypertension and Gout, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Prehypertension, Gout, Pulse Wave Velocity
What is being tested?: Febuxostat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Mar 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Univerisity Of California San Diego
San Diego, California, 92037

Other trials in United States

About this study

Official title: Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive

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.

Conditions: Prehypertension, Gout, Pulse Wave Velocity, Hypertension, 24 Hour Blood Pressure
Being tested: Febuxostat
Keywords: Prehypertension, Gout, Puls Wave Velocity, Hypertension, 24 hour blood pressure
Medical subject headings: Prehypertension, Gout, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FebuxostatDrug
Also called Uloric
80mg PO daily for 8 weeks

Study groups in NCT01472692
Study group	Role	What they receive
Febuxostat	Active comparator	Not described Receives: Drug: Febuxostat
Placebo	Placebo comparator	Not described Receives: Drug: Febuxostat

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in 24 Hour Blood Pressure
Measured: 8 weeks
Changes in Pulse Wave Velocity
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Mar 2014

First posted16 Nov 2011 (estimated)
Study startOct 2011
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PrehypertensionStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01472692
Sponsor's protocol ID: 110806
Status last verified: Nov 2019
First submitted: 13 Nov 2011
Last updated: 16 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gois PHF, Souza ERM. Pharmacotherapy for hyperuricaemia in hypertensive patients. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD008652. doi: 10.1002/14651858.CD008652.pub4.
PubMed 32877573

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
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Overweight, Prediabetic State
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Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
Prehypertension
Recruiting
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Prehypertension (Elevated Blood Pressure) or Hypertension, Healthy
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Adverse Event

All Prehypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive
ClinicalTrials.gov ID: NCT01472692
Acronym / sponsor ID: 110806
Conditions: Prehypertension, Gout, Pulse Wave Velocity, Hypertension, 24 Hour Blood Pressure
Keywords: Prehypertension, Gout, Puls Wave Velocity, Hypertension, 24 hour blood pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Study start: Oct 2011
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 16 Nov 2011 (estimated)
Results: Posted 16 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Febuxostat	Active comparator	Drug: Febuxostat
Placebo	Placebo comparator	Drug: Febuxostat

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FebuxostatAlso: Uloric80mg PO daily for 8 weeks	Drug	Febuxostat, Placebo

Primary outcome

Changes in 24 Hour Blood Pressure
Time frame: 8 weeks
Changes in Pulse Wave Velocity
Time frame: 8 weeks

Results and safety

Results posted to the registry on 16 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Febuxostat	0	0
Placebo	0	0

Primary outcome: Changes in 24 Hour Blood Pressure

Time frame: 8 weeks

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

Primary outcome: Changes in Pulse Wave Velocity

Time frame: 8 weeks

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

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Febuxostat	0 of 0	0 of 0	0
Placebo	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The Principal Investigator for this study has passed away and the results data is not available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32877573Gois PHF, Souza ERM. Pharmacotherapy for hyperuricaemia in hypertensive patients. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD008652. doi: 10.1002/14651858.CD008652.pub4.

Related trials for Prehypertension

RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Not yet recruiting
Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
Prehypertension
Recruiting
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Prehypertension (Elevated Blood Pressure) or Hypertension, Healthy
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Adverse Event

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel O'Connor, UCSD principal investigator

UCSD

Jason T. Davis, M.D. study director

University of California, San Diego

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Febuxostat in people with Prehypertension and Gout, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in 24 Hour Blood Pressure (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01472692, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.