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Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00430248
Recruitment Status : Completed
First Posted : February 1, 2007
Results First Posted : July 16, 2009
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Febuxostat
Drug: Allopurinol
Enrollment 2269
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.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily for up to 6 months. Febuxostat 80 mg, orally, once daily for up to 6 months. 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.
Period Title: Overall Study
Started 757 756 756
Completed 632 598 621
Not Completed 125 158 135
Reason Not Completed
Adverse Event             49             61             64
Protocol Violation             10             2             4
Personal Reasons             12             24             9
Lost to Follow-up             28             33             28
Therapeutic Failure             1             1             1
Withdrawal by Subject             14             20             16
Inclusion/Exclusion Criteria Not Met             0             2             0
Gout Flare             3             7             2
Reason Not Specified             8             8             11
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD Total
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily for up to 6 months. Febuxostat 80 mg, orally, once daily for up to 6 months. 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. Total of all reporting groups
Overall Number of Baseline Participants 757 756 756 2269
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
<45 years of age 192 196 180 568
45 to <65 years of age 450 432 445 1327
≥65 years of age 115 128 131 374
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
52.5  (11.68) 53.0  (11.79) 52.9  (11.73) 52.8  (11.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
Female
35
   4.6%
46
   6.1%
47
   6.2%
128
   5.6%
Male
722
  95.4%
710
  93.9%
709
  93.8%
2141
  94.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
Hispanic or Latino
47
   6.2%
49
   6.5%
53
   7.0%
149
   6.6%
Not Hispanic or Latino
710
  93.8%
707
  93.5%
702
  92.9%
2119
  93.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.1%
1
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
American Indian or Alaska Native
6
   0.8%
10
   1.3%
6
   0.8%
22
   1.0%
Asian
26
   3.4%
25
   3.3%
37
   4.9%
88
   3.9%
Native Hawaiian or Other Pacific Islander
11
   1.5%
10
   1.3%
11
   1.5%
32
   1.4%
Black or African American
83
  11.0%
78
  10.3%
67
   8.9%
228
  10.0%
White
620
  81.9%
618
  81.7%
625
  82.7%
1863
  82.1%
More than one race
11
   1.5%
15
   2.0%
8
   1.1%
34
   1.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   0.3%
2
   0.1%
Body Mass Index  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
<18.5 kilograms per meter² (kg/m²) 0 1 1 2
18.5 kg/m² to <25 kg/m² 50 46 42 138
25 kg/m² to <30 kg/m² 215 232 236 683
≥30 kg/m² 490 476 476 1442
Missing 2 1 1 4
Cardiovascular Disease  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
No 336 316 320 972
Yes 421 440 436 1297
Renal Function   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
Moderate Renal Impairment 130 136 136 402
Mild Renal Impairment 349 367 365 1081
Normal Renal Function 278 253 255 786
[1]
Measure Description:

Moderate renal impairment - baseline estimated creatinine clearance (CLcr) 30 milliliters per minute (mL/min) to 59 mL/min; Mild renal impairment - baseline estimated CLcr 60 mL/min to 89 mL/min; Normal renal function - estimated CLcr ≥90 mL/min.

CLcr calculated using the Cockroft-Gault formula corrected for ideal body weight.

Mean Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
32.9  (6.37) 32.9  (6.39) 32.7  (6.23) 32.8  (6.33)
Serum Urate  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter (mg/dL)
Number Analyzed 757 participants 756 participants 756 participants 2269 participants
9.6  (1.15) 9.6  (1.20) 9.5  (1.19) 9.6  (1.18)
1.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 757 756 755
Measure Type: Number
Unit of Measure: percentage of subjects
45.2 67.1 42.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.1
Confidence Interval 95%
-1.9 to 8.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparisons between treatment groups were performed using Fisher’s exact test (two-tailed 0.05 significance level).
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.9
Confidence Interval 95%
20.1 to 29.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparisons between treatment groups were performed using Fisher’s exact test (two-tailed 0.05 significance level).
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 21.9
Confidence Interval 95%
17.0 to 26.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 479 503 501
Measure Type: Number
Unit of Measure: percentage of subjects
49.7 71.6 42.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 703 691 685
Measure Type: Number
Unit of Measure: percentage of subjects
49.1 74.1 43.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 652 636 646
Measure Type: Number
Unit of Measure: percentage of subjects
47.1 75.2 45.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 618 596 616
Measure Type: Number
Unit of Measure: percentage of participants
48.9 75.3 46.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 703 691 685
Measure Type: Number
Unit of Measure: percentage of subjects
15.4 45.9 11.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 652 636 646
Measure Type: Number
Unit of Measure: percentage of subjects
15.0 51.6 13.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 618 596 616
Measure Type: Number
Unit of Measure: percentage of subjects
19.3 49.7 14.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a post-baseline serum urate value.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 757 756 755
Measure Type: Number
Unit of Measure: percentage of subjects
16.5 44.0 13.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 703 691 685
Measure Type: Number
Unit of Measure: percentage of subjects
2.1 17.5 1.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 652 636 646
Measure Type: Number
Unit of Measure: percentage of subjects
2.0 18.6 1.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.520
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 618 596 616
Measure Type: Number
Unit of Measure: percentage of subjects
3.1 20.3 1.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a post-baseline serum urate value.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 757 756 755
Measure Type: Number
Unit of Measure: percentage of subjects
2.5 17.5 1.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.196
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05 (two-tailed).
Method Fisher Exact
Comments [Not Specified]
14.Secondary Outcome
Title Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 703 691 685
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-35.1  (12.8) -44.5  (15.5) -33.8  (13.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
15.Secondary Outcome
Title Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 652 636 646
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-34.9  (13.1) -45.5  (15.6) -34.5  (12.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
16.Secondary Outcome
Title Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 618 596 616
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-35.6  (13.2) -45.1  (16.0) -34.4  (13.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
17.Secondary Outcome
Title Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects with a post-baseline serum urate value.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg, orally, once daily for up to 6 months.
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.
Overall Number of Participants Analyzed 757 756 755
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-33.1  (15.5) -40.6  (19.9) -31.3  (16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 200 mg or 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Febuxostat 80 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily for up to 6 months. Febuxostat 80 mg, orally, once daily for up to 6 months. 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.
All-Cause Mortality
Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19   28   31 
Blood and lymphatic system disorders       
Leukocytoses not elsewhere classified (NEC)  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Thrombocytopenias  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Cardiac disorders       
Cardiac Conduction Disorders  1  0/757 (0.00%)  2/756 (0.26%)  0/756 (0.00%) 
Cardiac Hypertensive Complications  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Coronary Artery Disorders NEC  1  2/757 (0.26%)  0/756 (0.00%)  2/756 (0.26%) 
Heart Failures NEC  1  2/757 (0.26%)  0/756 (0.00%)  1/756 (0.13%) 
Ischaemic Coronary Artery Disorders  1  1/757 (0.13%)  2/756 (0.26%)  1/756 (0.13%) 
Supraventricular Arrhythmias  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Ear and labyrinth disorders       
Inner Ear Signs and Symptoms  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Gastrointestinal disorders       
Acute and Chronic Pancreatitis  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)  1  1/757 (0.13%)  0/756 (0.00%)  0/756 (0.00%) 
Dyspeptic Signs and Symptoms  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Gastrointestinal Ulcers and Perforation, Site Unspecified  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Intestinal Haemorrhages  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Intestinal Ulcers and Perforation NEC  1  2/757 (0.26%)  1/756 (0.13%)  0/756 (0.00%) 
Nausea and Vomiting Symptoms  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Non-Site Specific Gastrointestinal Haemorrhages  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
General disorders       
General Signs and Symptoms NEC  1  1/757 (0.13%)  0/756 (0.00%)  0/756 (0.00%) 
Pain and Discomfort NEC  1  1/757 (0.13%)  2/756 (0.26%)  1/756 (0.13%) 
Hepatobiliary disorders       
Cholecystitis and Cholelithiasis  1  0/757 (0.00%)  0/756 (0.00%)  3/756 (0.40%) 
Immune system disorders       
Allergies to Food, Food Additives, Drugs and Other Chemicals  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Anaphylactic Responses  1  1/757 (0.13%)  0/756 (0.00%)  0/756 (0.00%) 
Infections and infestations       
Abdominal and Gastrointestinal Infections  1  2/757 (0.26%)  0/756 (0.00%)  1/756 (0.13%) 
Bacterial Infections NEC  1  1/757 (0.13%)  1/756 (0.13%)  2/756 (0.26%) 
Lower Respiratory Tract and Lung Infections  1  1/757 (0.13%)  1/756 (0.13%)  3/756 (0.40%) 
Sepsis, Bacteraemia, Viraemia, and Infections  1  0/757 (0.00%)  1/756 (0.13%)  1/756 (0.13%) 
Injury, poisoning and procedural complications       
Fractures and Dislocations NEC  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Muscle, Tendon and Ligament Injuries  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Non-Site Specific Injuries NEC  1  0/757 (0.00%)  2/756 (0.26%)  0/756 (0.00%) 
Non-Site Specific Procedural Complications  1  1/757 (0.13%)  0/756 (0.00%)  1/756 (0.13%) 
Upper limb Fractures and Dislocations  1  0/757 (0.00%)  1/756 (0.13%)  1/756 (0.13%) 
Metabolism and nutrition disorders       
Purine Metabolism Disorders NEC  1  0/757 (0.00%)  1/756 (0.13%)  1/756 (0.13%) 
Total Fluid Volume Decreased  1  1/757 (0.13%)  0/756 (0.00%)  0/756 (0.00%) 
Musculoskeletal and connective tissue disorders       
Joint Related Disorders NEC  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Joint Related Signs and Symptoms  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Osteoarthropathies  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder Neoplasms Malignant  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Breast and Nipple Neoplasms Malignant  1  1/757 (0.13%)  0/756 (0.00%)  0/756 (0.00%) 
Colonic Neoplasms Malignant  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Nervous System Neoplasms Unpecified Malignancy NEC  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Nonsmall Cell Neoplasm Malignant/Respiratory Type Specified  1  0/757 (0.00%)  0/756 (0.00%)  1/756 (0.13%) 
Prostatic Neoplasms Benign  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Prostatic Neoplasms Malignant  1  0/757 (0.00%)  1/756 (0.13%)  3/756 (0.40%) 
Nervous system disorders       
Central Nervous System Hemorrhages & Cerebrovascular Accidents  1  0/757 (0.00%)  1/756 (0.13%)  1/756 (0.13%) 
Disturbances in Consciousness NEC  1  0/757 (0.00%)  0/756 (0.00%)  3/756 (0.40%) 
Increased Intracranial Pressure Disorders  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Neurological Signs and Symptoms NEC  1  1/757 (0.13%)  0/756 (0.00%)  0/756 (0.00%) 
Transient Cerebrovascular Events  1  1/757 (0.13%)  1/756 (0.13%)  1/756 (0.13%) 
Renal and urinary disorders       
Renal Failure and Impairment  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Renal Vascular and Ischaemic Conditions  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Reproductive system and breast disorders       
Prostatic Signs, Symptoms and Disorders NEC  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasms and Obstruction  1  0/757 (0.00%)  1/756 (0.13%)  1/756 (0.13%) 
Pulmonary Thrombotic and Embolic Conditions  1  0/757 (0.00%)  1/756 (0.13%)  0/756 (0.00%) 
Vascular disorders       
Aortic Aneurysms and Dissections  1  1/757 (0.13%)  0/756 (0.00%)  1/756 (0.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 200 mg or 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   193   167   166 
Gastrointestinal disorders       
Diarrhoea (Excluding Infective)  1  45/757 (5.94%)  47/756 (6.22%)  57/756 (7.54%) 
Infections and infestations       
Upper Respiratory Tract Infections  1  71/757 (9.38%)  53/756 (7.01%)  57/756 (7.54%) 
Investigations       
Liver Function Analyses  1  63/757 (8.32%)  52/756 (6.88%)  50/756 (6.61%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal and Connective Tissues Signs and Symptoms NEC  1  43/757 (5.68%)  38/756 (5.03%)  32/756 (4.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Sr. VP, Clinical Sciences
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00430248     History of Changes
Other Study ID Numbers: F-GT06-153
U1111-1114-0226 ( Registry Identifier: WHO )
First Submitted: January 25, 2007
First Posted: February 1, 2007
Results First Submitted: March 12, 2009
Results First Posted: July 16, 2009
Last Update Posted: February 2, 2012