Trial · NCT02500641
Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
NCT02500641, Phase 4, Completed, Menarini International Operations Luxembourg SA; results first posted 2019-06-21
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout. Trials, record NCT02500641. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02500641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
- NCT number
- NCT02500641
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 196 participants, actual
- Lead sponsor
- Menarini International Operations Luxembourg SA
- Conditions
- Gout
- Interventions
- Febuxostat 80/120mg/day, Allopurinol 100 up to 600mg/day, Colchicine, Naproxen, Omeprazole
- First posted
- 2015-07-16
- Last updated
- 2019-06-21
- Other registries' IDs
- eudract:2014-005567-33
- Results first posted
- 2019-06-21
- Limitations and caveats
- No limitations or caveats are applicable to this summary
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulse Wave Velocity | 36 weeks of treatment | Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulse Wave Velocity | 36 weeks of treatment | All randomized subjects who had taken at least one dose of study drug specified by treatment group and performed at least one primary efficacy assessment (PWV) after randomization. | m/s | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulse Wave Velocity | Febuxostat 80/120 mg/Day | 9.0 | Standard Deviation 2.04 | m/s | |
| Pulse Wave Velocity | Allopurinol 100 up to 600 mg/Day | 9.05 | Standard Deviation 1.99 | m/s |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Febuxostat 80/120 mg/Day | 98 | |
| Overall Study | STARTED | Allopurinol 100 up to 600 mg/Day | 98 | |
| Overall Study | COMPLETED | Febuxostat 80/120 mg/Day | 88 | |
| Overall Study | COMPLETED | Allopurinol 100 up to 600 mg/Day | 86 | |
| Overall Study | NOT COMPLETED | Febuxostat 80/120 mg/Day | 10 | |
| Overall Study | NOT COMPLETED | Allopurinol 100 up to 600 mg/Day | 12 |
Source ClinicalTrials.gov
Adverse events182
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 | Hypertension | Vascular disorders | Febuxostat 80/120 mg/Day | 1 | 98 | 1 |
| other | Hypertension | Vascular disorders | Allopurinol 100 up to 600 mg/Day | 3 | 98 | 3 |
| other | Arteriosclerosis | Vascular disorders | Febuxostat 80/120 mg/Day | 0 | 98 | 0 |
| other | Arteriosclerosis | Vascular disorders | Allopurinol 100 up to 600 mg/Day | 1 | 98 | 1 |
| other | Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Febuxostat 80/120 mg/Day | 1 | 98 | 1 |
| other | Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Allopurinol 100 up to 600 mg/Day | 0 | 98 | 0 |
| other | edema peripheral | General disorders | Febuxostat 80/120 mg/Day | 2 | 98 | 2 |
| other | edema peripheral | General disorders | Allopurinol 100 up to 600 mg/Day | 3 | 98 | 3 |
| other | Alanine aminotransferase increased | Investigations | Febuxostat 80/120 mg/Day | 4 | 98 | 4 |
| other | Alanine aminotransferase increased | Investigations | Allopurinol 100 up to 600 mg/Day | 1 | 98 | 1 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Febuxostat 80/120 mg/Day | 0 | 98 |
| Total, all-cause mortality | Allopurinol 100 up to 600 mg/Day | 0 | 98 |
| Total, other adverse events | Febuxostat 80/120 mg/Day | 50 | 98 |
| Total, other adverse events | Allopurinol 100 up to 600 mg/Day | 61 | 98 |
| Total, serious adverse events | Febuxostat 80/120 mg/Day | 10 | 98 |
| Total, serious adverse events | Allopurinol 100 up to 600 mg/Day | 8 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Febuxostat 80/120 mg/Day vs Allopurinol 100 up to 600 mg/Day: deaths from any cause | Trial comparisons |
| Febuxostat 80/120 mg/Day vs Allopurinol 100 up to 600 mg/Day: 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/NCT02500641
GET https://conductscience.org/api/trials/v1/NCT02500641/events?page=2