A Phase 2/3 interventional study of Allopurinol and Placebo in Pre-hypertension and JNC 7 Stage I Hypertension, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by University of Alabama at Birmingham · Phase 2/3, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 99 is close to the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Allopurinol · Drug: Placebo
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.
Drug: Allopurinol · Drug: Placebo
Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.
Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks (pre-treatment vs. post-treatment serum levels)
| Milestone | Allopurinol Then Placebo | Placebo Then Allopurinol |
|---|---|---|
| Started | 52 | 47 |
| Completed | 48 | 42 |
| Not completed | 4 | 5 |
| Milestone | Allopurinol Then Placebo | Placebo Then Allopurinol |
|---|---|---|
| Started | 48 | 42 |
| Completed | 46 | 40 |
| Not completed | 2 | 2 |
| Milestone | Allopurinol Then Placebo | Placebo Then Allopurinol |
|---|---|---|
| Started | 46 | 40 |
| Completed | 44 | 38 |
| Not completed | 2 | 2 |
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.
| mm Hg | Allopurinol Phase | Placebo Phase |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | -1.39 ± 10.0 | -1.06 ± 8.94 |
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.
| percent change | Allopurinol Phase | Placebo Phase |
|---|---|---|
| Change in Flow-mediated Arterial Vasodilation | 2.5 ± 0.55 | -0.1 ± 0.42 |
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.
| mg/L | Allopurinol Phase | Placebo Phase |
|---|---|---|
| Change in Serum Levels of High Sensitivity C-reactive Protein | 0.6 ± 0.39 | 0.8 ± 0.82 |
Collected over Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Allopurinol | 0/99 (0%) | 0/99 (0%) | 12/99 (12.1%) |
| Placebo | 0/99 (0%) | 0/99 (0%) | 12/99 (12.1%) |
| Event | Allopurinol | Placebo |
|---|---|---|
| FatigueGeneral disorders | 3/99 | 1/99 |
| NauseaGastrointestinal disorders | 1/99 | 3/99 |
| DiarrheaGastrointestinal disorders | 1/99 | 2/99 |
| Increase Blood Pressure (>= 160 disastolic blood pressure or >=90 systolic blood pressure)Cardiac disorders | 1/99 | 0/99 |
| TachycardiaCardiac disorders | 0/99 | 1/99 |
| Hyper-defecationGastrointestinal disorders | 0/99 | 1/99 |
| DizzinessEar and labyrinth disorders | 0/99 | 1/99 |
| HeadacheNervous system disorders | 1/99 | 1/99 |
| DrowsinessGeneral disorders | 1/99 | 0/99 |
| ItchGeneral disorders | 1/99 | 1/99 |
Overall population baseline analytics are displayed. Data were collected prior to Phase 1 of the clinical trial.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 28.0 ± 7 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 37 |
| Male | 62 |
| Ethnicity (NIH/OMB)(Participants) | Overall |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 96 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 40 |
| White | 52 |
| More than one race | 2 |
| Unknown or Not Reported | 2 |
| Systolic Blood Pressure(mm Hg) | Overall |
|---|---|
| Mean | 127 ± 11.3 |
| Diastolic Blood Pressure(mm Hg) | Overall |
|---|---|
| Mean | 81.3 ± 9.7 |
| Body Mass Index(kg/m^2) | Overall |
|---|---|
| Mean | 30.8 ± 7.7 |
| Serum urate (mg/dL)(mg/dL) | Overall |
|---|---|
| Mean | 5.8 ± 1.2 |
2 further baseline measures are reported on the registry.
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University of Alabama at Birmingham