Trial · NCT01496469
Effect of Febuxostat on Blood Pressure
NCT01496469, Phase 2, Completed, Takeda; results first posted 2015-08-31
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Effect of Febuxostat on Blood Pressure. Trials, record NCT01496469. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01496469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Febuxostat on Blood Pressure
- NCT number
- NCT01496469
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- Febuxostat, Placebo
- First posted
- 2011-12-21
- Last updated
- 2015-08-31
- Results first posted
- 2015-08-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Baseline and Week 6 | The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. |
| Secondary | Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Baseline and Week 6 | The change in 24-hour mean DBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. |
| Secondary | Change From Baseline in Serum Urate Levels at Week 6 | Baseline and Week 6 |
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 From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Baseline and Week 6 | FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Baseline and Week 6 | FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Urate Levels at Week 6 | Baseline and Week 6 | FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Placebo | Baseline | 142.3 | Standard Error 1.21 | millimeters of mercury (mmHg) |
| Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Febuxostat 80 mg | Baseline | 139.5 | Standard Error 1.18 | millimeters of mercury (mmHg) |
| Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Placebo | Change at Week 6 | -3.4 | Standard Error 1.31 | millimeters of mercury (mmHg) |
| Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Febuxostat 80 mg | Change at Week 6 | -3.7 | Standard Error 1.27 | millimeters of mercury (mmHg) |
| Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Placebo | Baseline | 85.9 | Standard Error 1.14 | mmHg |
| Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Febuxostat 80 mg | Baseline | 83.0 | Standard Error 1.11 | mmHg |
| Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Placebo | Change at Week 6 | -2.7 | Standard Error 0.91 | mmHg |
| Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 | Febuxostat 80 mg | Change at Week 6 | -2.0 | Standard Error 0.88 | mmHg |
| Change From Baseline in Serum Urate Levels at Week 6 | Placebo | Baseline | 7.7 | Standard Error 0.14 | mg/dL |
| Change From Baseline in Serum Urate Levels at Week 6 | Febuxostat 80 mg | Baseline | 7.6 | Standard Error 0.14 | mg/dL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | STARTED | Febuxostat 80 mg | 61 | |
| Overall Study | COMPLETED | Placebo | 50 | |
| Overall Study | COMPLETED | Febuxostat 80 mg | 53 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Febuxostat 80 mg | 8 |
Source ClinicalTrials.gov
Adverse events6
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 1 | 60 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Febuxostat 80 mg | 3 | 61 | |
| serious | Coronary artery insufficiency | Cardiac disorders | Placebo | 0 | 60 | |
| serious | Coronary artery insufficiency | Cardiac disorders | Febuxostat 80 mg | 1 | 61 | |
| serious | Blood pressure increased | Investigations | Placebo | 1 | 60 | |
| serious | Blood pressure increased | Investigations | Febuxostat 80 mg | 0 | 61 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Febuxostat 80 mg | ||
| Total, other adverse events | Placebo | 1 | 60 |
| Total, other adverse events | Febuxostat 80 mg | 3 | 61 |
| Total, serious adverse events | Placebo | 1 | 60 |
| Total, serious adverse events | Febuxostat 80 mg | 1 | 61 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29102979 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Febuxostat 80 mg vs Placebo: serious adverse events |
Source 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/NCT01496469
GET https://conductscience.org/api/trials/v1/NCT01496469/registered