Trial · NCT02038179
Center of Research Translation (CORT) Project 2
NCT02038179, Phase 2, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2020-02-26
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Center of Research Translation (CORT) Project 2. Trials, record NCT02038179. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02038179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Center of Research Translation (CORT) Project 2
- NCT number
- NCT02038179
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 99 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Pre-hypertension, JNC 7 Stage I Hypertension
- Interventions
- Allopurinol, Placebo
- First posted
- 2014-01-16
- Last updated
- 2021-01-11
- Results first posted
- 2020-02-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Systolic Blood Pressure (SBP) | 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. |
| Primary | Change in Flow-mediated Arterial Vasodilation | 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. |
| Primary | Change in Serum Levels of High Sensitivity C-reactive Protein | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Systolic Blood Pressure (SBP) | 4 weeks (pre-treatment vs. post-treatment SBP) | Missing data was handled with a multiple imputations approach | mm Hg | MEAN |
| PRIMARY | Change in Flow-mediated Arterial Vasodilation | 4 weeks (pre-treatment vs. post-treatment FMD Values (%)) | Missing data was handled with a multiple imputation approach | percent change | MEAN |
| PRIMARY | Change in Serum Levels of High Sensitivity C-reactive Protein | 4 weeks (pre-treatment vs. post-treatment serum levels) | Data reported is imputed for missing. | mg/L | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Systolic Blood Pressure (SBP) | Allopurinol Phase | -1.39 | Standard Error 10.0 | mm Hg | |
| Change in Systolic Blood Pressure (SBP) | Placebo Phase | -1.06 | Standard Error 8.94 | mm Hg | |
| Change in Flow-mediated Arterial Vasodilation | Allopurinol Phase | 2.5 | Standard Error 0.55 | percent change | |
| Change in Flow-mediated Arterial Vasodilation | Placebo Phase | -0.1 | Standard Error 0.42 | percent change | |
| Change in Serum Levels of High Sensitivity C-reactive Protein | Allopurinol Phase | 0.6 | Standard Error 0.39 | mg/L | |
| Change in Serum Levels of High Sensitivity C-reactive Protein | Placebo Phase | 0.8 | Standard Error 0.82 | mg/L |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 (4 Weeks) | STARTED | Allopurinol Then Placebo | 52 | |
| Phase 1 (4 Weeks) | STARTED | Placebo Then Allopurinol | 47 | |
| Phase 1 (4 Weeks) | COMPLETED | Allopurinol Then Placebo | 48 | |
| Phase 1 (4 Weeks) | COMPLETED | Placebo Then Allopurinol | 42 | |
| Phase 1 (4 Weeks) | NOT COMPLETED | Allopurinol Then Placebo | 4 | |
| Phase 1 (4 Weeks) | NOT COMPLETED | Placebo Then Allopurinol | 5 | |
| Washout (2-4 Weeks) | STARTED | Allopurinol Then Placebo | 48 | |
| Washout (2-4 Weeks) | STARTED | Placebo Then Allopurinol | 42 | |
| Washout (2-4 Weeks) | COMPLETED | Allopurinol Then Placebo | 46 | |
| Washout (2-4 Weeks) | COMPLETED | Placebo Then Allopurinol | 40 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increase Blood Pressure (>= 160 disastolic blood pressure or >=90 systolic blood pressure) | Cardiac disorders | Allopurinol | 1 | 99 | 1 |
| other | Increase Blood Pressure (>= 160 disastolic blood pressure or >=90 systolic blood pressure) | Cardiac disorders | Placebo | 0 | 99 | 0 |
| other | Tachycardia | Cardiac disorders | Allopurinol | 0 | 99 | 0 |
| other | Tachycardia | Cardiac disorders | Placebo | 1 | 99 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Allopurinol | 1 | 99 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 99 | 2 |
| other | Hyper-defecation | Gastrointestinal disorders | Allopurinol | 0 | 99 | 0 |
| other | Hyper-defecation | Gastrointestinal disorders | Placebo | 1 | 99 | 1 |
| other | Dizziness | Ear and labyrinth disorders | Allopurinol | 0 | 99 | 0 |
| other | Dizziness | Ear and labyrinth disorders | Placebo | 1 | 99 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allopurinol | 0 | 99 |
| Total, all-cause mortality | Placebo | 0 | 99 |
| Total, other adverse events | Allopurinol | 12 | 99 |
| Total, other adverse events | Placebo | 12 | 99 |
| Total, serious adverse events | Allopurinol | 0 | 99 |
| Total, serious adverse events | Placebo | 0 | 99 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50AR060772 | INvestigations In Gout, Hyperuricemia, and comorbidiTies (INSIGHT) Center of Research Translation (CORT) | SAAG, KENNETH G | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2012 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Allopurinol vs Placebo: deaths from any cause | Trial comparisons |
| Allopurinol vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02038179
GET https://conductscience.org/api/trials/v1/NCT02038179/events?page=2