Blood PressureNCT01701622
The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study
A study testing febuxostat in people with Blood Pressure and Gout, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure, Gout
- What is being tested?
- febuxostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2011
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients currently treated at the University of Mississippi Medical Center General Internal Medicine/Hypertension or Family Medicine Clinics.
- Have a diagnosis of gout.
- Taking allopurinol at a stable dose for at least 2 months.
Who cannot join
- Less than 18 years old.
- Severe renal impairment defined as CrCl <30 mL/min.
- Previous diagnosis of severe hepatic impairment.
- Currently taking azathioprine, mercaptopurine, or theophylline.
- Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.
- Arm circumference greater than 50 cm.
- Change in antihypertensive medication within the previous 2 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center General Medicine/Hypertension and Family Medicine Clinics
Jackson, Mississippi, 39216
About this study
Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. It has been repeatedly noted that hyperuricemia was an independent risk factor of death in those at high cardiovascular disease risk. A recent review concluded that there is strong evidence that hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.
Although this correlation of hypertension and hyperuricemia is known, there has only been one published study that has evaluated if lowering the uric acid would reduce the blood pressure. The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased the blood pressure. Despite this, further evaluation of this therapeutic approach has not been studied.
The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood pressure lowering effects superior to allopurinol in patients diagnosed with gout.
Read the detailed description
Screening and Recruitment
- Identify and recruit 20 participants from the University of Mississippi Medical Center General Internal Medicine/Hypertension and Family Medicine Clinics.
- Participants must be currently taking allopurinol for the treatment of gout and be on a stable dose of allopurinol for at least 2 months.
- Any antihypertensive medications must be at stable doses for at least 2 months.
- The identified patients will be invited to participate in the study.
Provide Consent
- IRB approved comprehension survey will be administered to participants in determination of competency to provide consent.
- The "Consent to Participate in Research" information will be discussed with each participant and consent acquired.
- Materials can be taken by the potential participant to review and consent provided at a later date.
Data collection
- After consent is provided, study personnel will evaluate blood pressure (BP).
- Participants will undergo 24-hour Ambulatory Blood Pressure Monitor (ABPM). The normal fee for ABPM will be waived.
- Participants will then discontinue allopurinol and initiate febuxostat at a comparable dose. Febuxostat will be provided to all participants at no cost.
- If receiving < 300 mg allopurinol daily, will provide febuxostat 40 mg daily.
- If receiving > 300 mg allopurinol daily, will provide febuxostat 80 mg daily.
- After at least 4 weeks of febuxostat, the participant will repeat 24-hour ABPM. The normal fee for ABPM will be waived.
- After completion of the febuxostat portion of the study, participants will receive a compensation of $50 at the end of the study. Compensation will only be provided to those who complete the entire study.
Results
- Data collection will be added to participant's permanent medical records.
- Results for individual participants will be discussed with the participant as well as their primary care provider.
- The decision to remain on febuxostat or resume allopurinol will lie with the primary care provider.
- Conditions
- Blood Pressure, Gout
- Being tested
- febuxostat
- Keywords
- Blood Pressure, Gout, allopurinol, febuxostat, uric acid
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
febuxostatDrug
Also called Uloric
If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol, febuxostat | Experimental | Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. Receives: Drug: febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings
The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.
Measured: 4 to 5 weeks
Secondary outcomes (1)
If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)
measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.
Measured: Participants will be followed for an expected average of 4 to 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: unable to enroll participants
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.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Minor, University of Mississippi Medical Center
- Investigators
- Amber S Holdiness, PharmD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701622
- Sponsor's protocol ID
- 2009-0186
- Status last verified
- Dec 2017
- First submitted
- 27 Jan 2010
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study
- ClinicalTrials.gov ID
- NCT01701622
- Acronym / sponsor ID
- 2009-0186
- Conditions
- Blood Pressure, Gout
- Keywords
- Blood Pressure, Gout, allopurinol, febuxostat, uric acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Posted 11 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. It has been repeatedly noted that hyperuricemia was an independent risk factor of death in those at high cardiovascular disease risk. A recent review concluded that there is strong evidence that hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.
Although this correlation of hypertension and hyperuricemia is known, there has only been one published study that has evaluated if lowering the uric acid would reduce the blood pressure. The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased the blood pressure. Despite this, further evaluation of this therapeutic approach has not been studied.
The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood pressure lowering effects superior to allopurinol in patients diagnosed with gout.
Detailed description
Screening and Recruitment
- Identify and recruit 20 participants from the University of Mississippi Medical Center General Internal Medicine/Hypertension and Family Medicine Clinics.
- Participants must be currently taking allopurinol for the treatment of gout and be on a stable dose of allopurinol for at least 2 months.
- Any antihypertensive medications must be at stable doses for at least 2 months.
- The identified patients will be invited to participate in the study.
Provide Consent
- IRB approved comprehension survey will be administered to participants in determination of competency to provide consent.
- The "Consent to Participate in Research" information will be discussed with each participant and consent acquired.
- Materials can be taken by the potential participant to review and consent provided at a later date.
Data collection
- After consent is provided, study personnel will evaluate blood pressure (BP).
- Participants will undergo 24-hour Ambulatory Blood Pressure Monitor (ABPM). The normal fee for ABPM will be waived.
- Participants will then discontinue allopurinol and initiate febuxostat at a comparable dose. Febuxostat will be provided to all participants at no cost.
- If receiving < 300 mg allopurinol daily, will provide febuxostat 40 mg daily.
- If receiving > 300 mg allopurinol daily, will provide febuxostat 80 mg daily.
- After at least 4 weeks of febuxostat, the participant will repeat 24-hour ABPM. The normal fee for ABPM will be waived.
- After completion of the febuxostat portion of the study, participants will receive a compensation of $50 at the end of the study. Compensation will only be provided to those who complete the entire study.
Results
- Data collection will be added to participant's permanent medical records.
- Results for individual participants will be discussed with the participant as well as their primary care provider.
- The decision to remain on febuxostat or resume allopurinol will lie with the primary care provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allopurinol, febuxostat | Experimental | Drug: febuxostatPatients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients currently treated at the University of Mississippi Medical Center General Internal Medicine/Hypertension or Family Medicine Clinics.
- Have a diagnosis of gout.
- Taking allopurinol at a stable dose for at least 2 months.
Key exclusion criteria (7 listed)
- Less than 18 years old.
- Severe renal impairment defined as CrCl <30 mL/min.
- Previous diagnosis of severe hepatic impairment.
- Currently taking azathioprine, mercaptopurine, or theophylline.
- Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.
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: UloricIf baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks. | Drug | Allopurinol, febuxostat |
Primary outcome
BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings
Time frame: 4 to 5 weeks
The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.
1 secondary outcome
If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)
Time frame: Participants will be followed for an expected average of 4 to 5 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amber S Holdiness, PharmD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing febuxostat in people with Blood Pressure and Gout, run by University of Mississippi Medical Center 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Jan 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2013). 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?
BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings (time frame: 4 to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2018.