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| ID | Type | Description | Link |
|---|---|---|---|
| P50AR060772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug | Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 4 weeks (pre-treatment vs. post-treatment serum levels) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34493347 | Derived | 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. | |
| 33779064 | Derived | 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. |
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Participants completed a 2-4 week placebo run-in prior to assignment to study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Allopurinol Then Placebo | Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks. The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol (300 mg per day PO) or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol (300 mg per day PO) or placebo for an additional 4 weeks. |
| FG001 | Placebo Then Allopurinol | Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks. The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol (300 mg per day PO) or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol (300 mg per day PO) or placebo for an additional 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 (4 Weeks) |
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| Washout (2-4 Weeks) |
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| Phase 2 (4 Weeks) |
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Overall population baseline analytics are displayed. Data were collected prior to Phase 1 of the clinical trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks. Placebo: The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Missing data was handled with a multiple imputations approach | Posted | Mean | Standard Error | mm Hg | 4 weeks (pre-treatment vs. post-treatment SBP) |
|
Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allopurinol | Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks. The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase Blood Pressure (>= 160 disastolic blood pressure or >=90 systolic blood pressure) | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Rahn | University of Alabama at Birmingham | 205-996-6552 | elizabethrahn@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 12, 2018 | Jan 3, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Systolic Blood Pressure | Systolic Blood Pressure collected via in-office sphygmomanometer. Report is the mean of 2 measurements. | Mean | Standard Deviation | mm Hg |
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| Diastolic Blood Pressure | Diastolic Blood Pressure collected via in-office sphygmomanometer. Report is the mean of 2 measurements. | Mean | Standard Deviation | mm Hg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Serum urate (mg/dL) | Mean | Standard Deviation | mg/dL |
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| Flow Mediated Dilation | Not all participants successfully completed flow mediated dilation testing at baseline. | Mean | Standard Deviation | percentage of dilation |
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| high sensitivity C-reactive protein (hs-CRP) | Not all participants had successful lab draws measuring highly sensitive C-reactive protein (hs-CRP) at baseline. | Mean | Standard Deviation | mg/L |
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Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received placebo, daily (PO) for approximately four weeks. |
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|
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| Primary | 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. | Missing data was handled with a multiple imputation approach | Posted | Mean | Standard Error | percent change | 4 weeks (pre-treatment vs. post-treatment FMD Values (%)) |
|
|
|
|
| Primary | 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. | Data reported is imputed for missing. | Posted | Mean | Standard Error | mg/L | 4 weeks (pre-treatment vs. post-treatment serum levels) |
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| 0 |
| 99 |
| 0 |
| 99 |
| 12 |
| 99 |
| EG001 | Placebo | Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks. The subjects will be randomized to receive placebo once daily by mouth. | 0 | 99 | 0 | 99 | 12 | 99 |
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Hyper-defecation | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Drowsiness | General disorders | Non-systematic Assessment |
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| Itch | General disorders | Non-systematic Assessment |
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| Abnormal Menses | Reproductive system and breast disorders | Non-systematic Assessment |
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| Weight Gain | General disorders | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment | Reduced white blood cell count |
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| Elevated Liver Enzyme | Hepatobiliary disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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