Pre-hypertensionPhase 2/3NCT02038179

Center of Research Translation (CORT) Project 2

A Phase 2/3 study testing Allopurinol in people with Pre-hypertension and JNC 7 Stage I Hypertension, run by University of Alabama at Birmingham 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 40 yearsHealthy volunteers can take part
Conditions the study is for: Pre-hypertension, JNC 7 Stage I Hypertension
What is being tested?: Allopurinol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Aug 2018
Phase: Phase 2/3
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
Systolic blood pressure (SBP) ≥ 120 and <160 or;
Diastolic blood pressure (DBP) ≥ 80 and < 100
Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
Age 18-40

Who cannot join

Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
Estimated glomerular filtration rate < 60 mL/min/1.73m2
Current use of any urate-lowering therapy or statins
Prior diagnosis of gout or past use of urate-lowering therapy for gout
Prior diagnosis of diabetes
Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months

Show all 11Show fewer

Active smokers
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: University of Alabama at Birmingham CORT Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole.

Conditions: Pre-hypertension, JNC 7 Stage I Hypertension
Being tested: Allopurinol, Placebo
Keywords: Pre-hypertension, JNC 7 stage I hypertension
Medical subject headings: Prehypertension

What participants receive

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

AllopurinolDrug
Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.
PlaceboDrug
Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.

Study groups in NCT02038179
Study group	Role	What they receive
Allopurinol, Then Placebo	Experimental	Participants will be asked to take 4 weeks of allopurinol (300 mg oral per day), then will crossover (after 2-4 week washout period) and take placebo for an additional 4 weeks. Receives: Drug: Allopurinol; Drug: Placebo
Placebo, Then Allopurinol	Experimental	Participants will be asked to take 4 weeks of placebo, then will crossover (after 2-4 week washout period) and take allopurinol (300 mg oral per day) for an additional 4 weeks. Receives: Drug: Allopurinol; Drug: Placebo

What is being measured

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

Change in Systolic Blood Pressure (SBP)
Compare systolic blood pressure (SBP) captured by wearing a 24 hour ambulatory blood pressure monitor during each phase of treatment (allopurinol 300 mg/day PO or placebo). Change in systolic blood pressure is calculated by comparing SBP at the end of each treatment phase to pre-treatment values.
Measured: 4 weeks (pre-treatment vs. post-treatment SBP)
Change in Flow-mediated Arterial Vasodilation
Compare endothelial function as indexed by flow-mediated arterial vasodilation (FMD) within each phase of treatment (allopurinol 300 mg/day PO or placebo). Percent (%) change in FMD is calculated by comparing FMD (%) at the end of each treatment phase to pre-treatment values.
Measured: 4 weeks (pre-treatment vs. post-treatment FMD Values (%))
Change in Serum Levels of High Sensitivity C-reactive Protein
Serum level of high sensitivity C-reactive protein will be reported as a change during treatment phase (allopurinol 300 mg/day PO or placebo). Change in serum level of C-reactive protein is calculated by comparing serum values at the end of each treatment phase to pre-treatment levels.
Measured: 4 weeks (pre-treatment vs. post-treatment serum levels)

Timeline

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

Jul 2014Aug 2018

First posted16 Jan 2014 (estimated)
Study startJul 2014
Primary completionAug 2018
Study completionAug 2018

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 (2)Papers the sponsor has linked to this study.
Other trials for Pre-hypertensionStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02038179
Sponsor's protocol ID: F130408004
Other IDs: P50AR060772
Status last verified: Jan 2021
First submitted: 20 Dec 2013
Last updated: 11 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Shaffer A, Rahn E, Saag K, Mudano A, Gaffo A. Variation in serum urate levels in the absence of gout and urate lowering therapy. BMC Rheumatol. 2021 Sep 8;5(1):32. doi: 10.1186/s41927-021-00202-6.
PubMed 34493347
Gaffo AL, Calhoun DA, Rahn EJ, Oparil S, Li P, Dudenbostel T, Feig DI, Redden DT, Muntner P, Foster PJ, Biggers-Clark SR, Mudano A, Sattui SE, Saddekni MB, Bridges SL Jr, Saag KG. Effect of Serum Urate Lowering With Allopurinol on Blood Pressure in Young Adults: A Randomized, Controlled, Crossover Trial. Arthritis Rheumatol. 2021 Aug;73(8):1514-1522. doi: 10.1002/art.41749. Epub 2021 Jun 5.
PubMed 33779064

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

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All Pre-hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: University of Alabama at Birmingham CORT Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure
ClinicalTrials.gov ID: NCT02038179
Acronym / sponsor ID: F130408004
Conditions: Pre-hypertension, JNC 7 Stage I Hypertension
Keywords: Pre-hypertension, JNC 7 stage I hypertension
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: Jul 2014
Primary completion: Aug 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 16 Jan 2014 (estimated)
Results: Posted 26 Feb 2020

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Allopurinol, Then Placebo	Experimental	Drug: Allopurinol, Drug: PlaceboParticipants will be asked to take 4 weeks of allopurinol (300 mg oral per day), then will crossover (after 2-4 week washout period) and take placebo for an additional 4 weeks.
Placebo, Then Allopurinol	Experimental	Drug: Allopurinol, Drug: PlaceboParticipants will be asked to take 4 weeks of placebo, then will crossover (after 2-4 week washout period) and take allopurinol (300 mg oral per day) for an additional 4 weeks.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
Systolic blood pressure (SBP) ≥ 120 and <160 or;
Diastolic blood pressure (DBP) ≥ 80 and < 100
Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
Age 18-40

Key exclusion criteria (11 listed)

Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
Estimated glomerular filtration rate < 60 mL/min/1.73m2
Current use of any urate-lowering therapy or statins
Prior diagnosis of gout or past use of urate-lowering therapy for gout
Prior diagnosis of diabetes

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
AllopurinolParticipants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.	Drug	Allopurinol, Then Placebo, Placebo, Then Allopurinol
PlaceboParticipants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.	Drug	Allopurinol, Then Placebo, Placebo, Then Allopurinol

Primary outcome

Change in Systolic Blood Pressure (SBP)
Time frame: 4 weeks (pre-treatment vs. post-treatment SBP)
Compare systolic blood pressure (SBP) captured by wearing a 24 hour ambulatory blood pressure monitor during each phase of treatment (allopurinol 300 mg/day PO or placebo). Change in systolic blood pressure is calculated by comparing SBP at the end of each treatment phase to pre-treatment values.
Change in Flow-mediated Arterial Vasodilation
Time frame: 4 weeks (pre-treatment vs. post-treatment FMD Values (%))
Compare endothelial function as indexed by flow-mediated arterial vasodilation (FMD) within each phase of treatment (allopurinol 300 mg/day PO or placebo). Percent (%) change in FMD is calculated by comparing FMD (%) at the end of each treatment phase to pre-treatment values.
Change in Serum Levels of High Sensitivity C-reactive Protein
Time frame: 4 weeks (pre-treatment vs. post-treatment serum levels)
Serum level of high sensitivity C-reactive protein will be reported as a change during treatment phase (allopurinol 300 mg/day PO or placebo). Change in serum level of C-reactive protein is calculated by comparing serum values at the end of each treatment phase to pre-treatment levels.

Results and safety

Results posted to the registry on 26 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allopurinol Then Placebo	52	48
Placebo Then Allopurinol	47	42

Primary outcome: Change in Systolic Blood Pressure (SBP)

Time frame: 4 weeks (pre-treatment vs. post-treatment SBP). Mean (Standard Error). Unit: mm Hg

Measure	Allopurinol Phase n = 99	Placebo Phase n = 99
Value	-1.39 (10.0)	-1.06 (8.94)

Allopurinol Phase vs Placebo Phase: p = 0.83, paired t-test

Population analysed: Missing data was handled with a multiple imputations approach

Primary outcome: Change in Flow-mediated Arterial Vasodilation

Time frame: 4 weeks (pre-treatment vs. post-treatment FMD Values (%)). Mean (Standard Error). Unit: percent change

Measure	Allopurinol Phase n = 99	Placebo Phase n = 99
Value	2.5 (0.55)	-0.1 (0.42)

Allopurinol Phase vs Placebo Phase: p <0.001, paired t-test

Population analysed: Missing data was handled with a multiple imputation approach

Primary outcome: Change in Serum Levels of High Sensitivity C-reactive Protein

Time frame: 4 weeks (pre-treatment vs. post-treatment serum levels). Mean (Standard Error). Unit: mg/L

Measure	Allopurinol Phase n = 99	Placebo Phase n = 99
Value	0.6 (0.39)	0.8 (0.82)

Allopurinol Phase vs Placebo Phase: p = 0.84, paired t-test

Population analysed: Data reported is imputed for missing.

Adverse events

Time frame: Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allopurinol	0 of 99 (0%)	12 of 99 (12.1%)	0 of 99
Placebo	0 of 99 (0%)	12 of 99 (12.1%)	0 of 99

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34493347Shaffer A, Rahn E, Saag K, Mudano A, Gaffo A. Variation in serum urate levels in the absence of gout and urate lowering therapy. BMC Rheumatol. 2021 Sep 8;5(1):32. doi: 10.1186/s41927-021-00202-6.
Derived from this study: PubMed 33779064Gaffo AL, Calhoun DA, Rahn EJ, Oparil S, Li P, Dudenbostel T, Feig DI, Redden DT, Muntner P, Foster PJ, Biggers-Clark SR, Mudano A, Sattui SE, Saddekni MB, Bridges SL Jr, Saag KG. Effect of Serum Urate Lowering With Allopurinol on Blood Pressure in Young Adults: A Randomized, Controlled, Crossover Trial. Arthritis Rheumatol. 2021 Aug;73(8):1514-1522. doi: 10.1002/art.41749. Epub 2021 Jun 5.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Allopurinol in people with Pre-hypertension and JNC 7 Stage I Hypertension, run by University of Alabama at Birmingham 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 11 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 11 Jan 2021. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Feb 2020). 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?

Change in Systolic Blood Pressure (SBP) (time frame: 4 weeks (pre-treatment vs. post-treatment SBP)). The study lists 3 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 NCT02038179, which also lists 2 linked publications.

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 11 Jan 2021.