Gout
Conditions
Keywords
tophi, hyperuricemia, uric acid, Drug Therapy
Brief summary
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
Detailed description
Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout. Treatment duration will be 6 months.
Interventions
DRUGFebuxostat
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
DRUGAllopurinol
Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months. Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Has one or more of the American Rheumatism Association criteria for the diagnosis of gout. * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).
Exclusion criteria
* Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study. * Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation. * History of xanthinuria. * Alcohol consumption greater than 14/week. * History of significant concomitant illness. * Active liver or peptic ulcer disease. * Has rheumatoid arthritis requiring treatment. * Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight. * Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | Last Visit on treatment (up to 6 months) | The percentage of subjects whose serum urate level was \<6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | Month 2 | Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 2 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | Month 4 | Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 4 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. | Month 6 | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. | Month 2 | Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 2 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. | Month 4 | Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 4 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. | Month 6 | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 6 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. | Last Visit on treatment (up to 6 months) | The percentage of subjects whose serum urate level was \<5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected. |
| Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | Last Visit on treatment (up to 6 months) | The percentage of subjects with mild-to-moderate renal impairment whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. |
| Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit | Month 4 | Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 4 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit | Month 6 | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 6 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit | Last Visit on treatment (up to 6 months) | The percentage of subjects whose serum urate level was \<4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected. |
| Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit. | Baseline and Month 2 | Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized. |
| Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit | Baseline and Month 4 | Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized. |
| Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit. | Baseline and Month 6 | Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized. |
| Mean Percent Change From Baseline in Serum Urate Levels at Final Visit. | Baseline and Last Visit on treatment (up to 6 months) | The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected. |
| Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit | Month 2 | Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 2 visit was summarized. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 324 sites in the United States from 16 February 2007 to 12 March 2008.
Pre-assignment details
Subjects who were currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Febuxostat 40 mg QD Febuxostat 40 mg, orally, once daily for up to 6 months. | 757 |
| Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily for up to 6 months. | 756 |
| Allopurinol 200 mg or 300 mg QD Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD. | 756 |
| Total | 2,269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 49 | 61 | 64 |
| Overall Study | Gout Flare | 3 | 7 | 2 |
| Overall Study | Inclusion/Exclusion Criteria Not Met | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 28 | 33 | 28 |
| Overall Study | Personal Reasons | 12 | 24 | 9 |
| Overall Study | Protocol Violation | 10 | 2 | 4 |
| Overall Study | Reason Not Specified | 8 | 8 | 11 |
| Overall Study | Therapeutic Failure | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 14 | 20 | 16 |
Baseline characteristics
| Characteristic | Febuxostat 40 mg QD | Total | Allopurinol 200 mg or 300 mg QD | Febuxostat 80 mg QD |
|---|---|---|---|---|
| Age Continuous | 52.5 years STANDARD_DEVIATION 11.68 | 52.8 years STANDARD_DEVIATION 11.73 | 52.9 years STANDARD_DEVIATION 11.73 | 53.0 years STANDARD_DEVIATION 11.79 |
| Age, Customized 45 to <65 years of age | 450 subjects | 1327 subjects | 445 subjects | 432 subjects |
| Age, Customized <45 years of age | 192 subjects | 568 subjects | 180 subjects | 196 subjects |
| Age, Customized ≥65 years of age | 115 subjects | 374 subjects | 131 subjects | 128 subjects |
| Body Mass Index 18.5 kg/m² to <25 kg/m² | 50 subjects | 138 subjects | 42 subjects | 46 subjects |
| Body Mass Index <18.5 kilograms per meter² (kg/m²) | 0 subjects | 2 subjects | 1 subjects | 1 subjects |
| Body Mass Index 25 kg/m² to <30 kg/m² | 215 subjects | 683 subjects | 236 subjects | 232 subjects |
| Body Mass Index ≥30 kg/m² | 490 subjects | 1442 subjects | 476 subjects | 476 subjects |
| Body Mass Index Missing | 2 subjects | 4 subjects | 1 subjects | 1 subjects |
| Cardiovascular Disease No | 336 subjects | 972 subjects | 320 subjects | 316 subjects |
| Cardiovascular Disease Yes | 421 subjects | 1297 subjects | 436 subjects | 440 subjects |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants | 149 Participants | 53 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 710 Participants | 2119 Participants | 702 Participants | 707 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Mean Body Mass Index | 32.9 kg/m² STANDARD_DEVIATION 6.37 | 32.8 kg/m² STANDARD_DEVIATION 6.33 | 32.7 kg/m² STANDARD_DEVIATION 6.23 | 32.9 kg/m² STANDARD_DEVIATION 6.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 22 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 88 Participants | 37 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 83 Participants | 228 Participants | 67 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 34 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 11 Participants | 32 Participants | 11 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 620 Participants | 1863 Participants | 625 Participants | 618 Participants |
| Renal Function Mild Renal Impairment | 349 subjects | 1081 subjects | 365 subjects | 367 subjects |
| Renal Function Moderate Renal Impairment | 130 subjects | 402 subjects | 136 subjects | 136 subjects |
| Renal Function Normal Renal Function | 278 subjects | 786 subjects | 255 subjects | 253 subjects |
| Serum Urate | 9.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 1.15 | 9.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 1.18 | 9.5 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 1.19 | 9.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 35 Participants | 128 Participants | 47 Participants | 46 Participants |
| Sex: Female, Male Male | 722 Participants | 2141 Participants | 709 Participants | 710 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 193 / — | 167 / — | 166 / — |
| serious Total, serious adverse events | 19 / — | 28 / — | 31 / — |
Outcome results
Primary
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
The percentage of subjects whose serum urate level was \<6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.
Time frame: Last Visit on treatment (up to 6 months)
Population: Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | 45.2 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | 67.1 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | 42.1 percentage of subjects |
Comparison: The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.95% CI: [-1.9, 8.1]
p-value: 0.233Fisher Exact
p-value: <0.00195% CI: [20.1, 29.8]Fisher Exact
p-value: <0.00195% CI: [17, 26.8]Fisher Exact
Secondary
Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.
The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time frame: Baseline and Last Visit on treatment (up to 6 months)
Population: Analysis was performed on the ITT subjects with a post-baseline serum urate value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Final Visit. | -33.1 percent change from baseline | Standard Deviation 15.5 |
| Febuxostat 80 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Final Visit. | -40.6 percent change from baseline | Standard Deviation 19.9 |
| Allopurinol 200 mg or 300 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Final Visit. | -31.3 percent change from baseline | Standard Deviation 16.2 |
p-value: 0.05ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.
Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.
Time frame: Baseline and Month 2
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit. | -35.1 percent change from baseline | Standard Deviation 12.8 |
| Febuxostat 80 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit. | -44.5 percent change from baseline | Standard Deviation 15.5 |
| Allopurinol 200 mg or 300 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit. | -33.8 percent change from baseline | Standard Deviation 13.2 |
p-value: 0.079ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit
Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.
Time frame: Baseline and Month 4
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit | -34.9 percent change from baseline | Standard Deviation 13.1 |
| Febuxostat 80 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit | -45.5 percent change from baseline | Standard Deviation 15.6 |
| Allopurinol 200 mg or 300 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit | -34.5 percent change from baseline | Standard Deviation 12.8 |
p-value: 0.685ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Time frame: Baseline and Month 6
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit. | -35.6 percent change from baseline | Standard Deviation 13.2 |
| Febuxostat 80 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit. | -45.1 percent change from baseline | Standard Deviation 16 |
| Allopurinol 200 mg or 300 mg QD | Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit. | -34.4 percent change from baseline | Standard Deviation 13.3 |
p-value: 0.153ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
The percentage of subjects with mild-to-moderate renal impairment whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time frame: Last Visit on treatment (up to 6 months)
Population: Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | 49.7 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | 71.6 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | 42.3 percentage of subjects |
p-value: 0.021Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit
The percentage of subjects whose serum urate level was \<4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Time frame: Last Visit on treatment (up to 6 months)
Population: Analysis was performed on the ITT subjects with a post-baseline serum urate value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit | 2.5 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit | 17.5 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit | 1.5 percentage of subjects |
p-value: 0.196Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 2 visit was summarized.
Time frame: Month 2
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit | 2.1 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit | 17.5 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit | 1.5 percentage of subjects |
p-value: 0.421Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 4 visit was summarized.
Time frame: Month 4
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit | 2.0 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit | 18.6 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit | 1.4 percentage of subjects |
p-value: 0.52Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 6 visit was summarized.
Time frame: Month 6
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit | 3.1 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit | 20.3 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit | 1.8 percentage of subjects |
p-value: 0.195Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.
The percentage of subjects whose serum urate level was \<5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Time frame: Last Visit on treatment (up to 6 months)
Population: Analysis was performed on the ITT subjects with a post-baseline serum urate value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. | 16.5 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. | 44.0 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. | 13.2 percentage of subjects |
p-value: 0.083Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 2 visit was summarized.
Time frame: Month 2
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. | 15.4 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. | 45.9 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. | 11.7 percentage of subjects |
p-value: 0.05Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 4 visit was summarized.
Time frame: Month 4
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. | 15.0 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. | 51.6 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. | 13.5 percentage of subjects |
p-value: 0.428Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 6 visit was summarized.
Time frame: Month 6
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. | 19.3 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. | 49.7 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. | 14.8 percentage of subjects |
p-value: 0.041Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 2 visit was summarized.
Time frame: Month 2
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | 49.1 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | 74.1 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | 43.2 percentage of subjects |
p-value: 0.031Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 4 visit was summarized.
Time frame: Month 4
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | 47.1 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | 75.2 percentage of subjects |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | 45.5 percentage of subjects |
p-value: 0.578Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized.
Time frame: Month 6
Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. | 48.9 percentage of participants |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. | 75.3 percentage of participants |
| Allopurinol 200 mg or 300 mg QD | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. | 46.6 percentage of participants |
p-value: 0.426Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact