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| Study Type: | Interventional |
|---|---|
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
| Condition: |
Gout |
| Intervention: |
Drug: Febuxostat |
Baseline Characteristics
| Description | |
|---|---|
| Febuxostat 40 mg QD | Febuxostat 40 mg orally, once daily, based on serum urate level. |
| Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily, based on serum urate level |
| Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily, based on serum urate level |
| Febuxostat 40 mg QD | Febuxostat 80 mg QD | Febuxostat 120 mg QD | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
8 | 79 | 29 | 116 |
|
Age, Customized [units: Subjects] |
||||
| <45 years | 2 | 20 | 9 | 31 |
| 45 to <65 years | 4 | 40 | 15 | 59 |
| ≥65 years | 2 | 19 | 5 | 26 |
|
Age [units: years] Mean ± Standard Deviation |
54.5 ± 11.44 | 53.9 ± 12.85 | 51.3 ± 13.01 | 53.3 ± 12.74 |
|
Gender [units: subjects] |
||||
| Female | 0 | 9 | 2 | 11 |
| Male | 8 | 70 | 27 | 105 |
|
History of Kidney Stone [units: Subjects] |
||||
| Yes | 0 | 11 | 3 | 14 |
| No | 8 | 68 | 26 | 102 |
|
Presence of Tophus [units: Subjects] |
||||
| Yes | 1 | 13 | 12 | 26 |
| No | 7 | 66 | 17 | 90 |
|
Race/Ethnicity [units: Subjects] |
||||
| Asian | 0 | 0 | 2 | 2 |
| Black or African American | 1 | 5 | 3 | 9 |
| White | 7 | 71 | 21 | 99 |
| Hispanic | 0 | 2 | 1 | 3 |
| Other | 0 | 1 | 2 | 3 |
|
Renal Function[1] [units: Subjects] |
||||
| Normal | 3 | 33 | 12 | 48 |
| Impaired | 5 | 46 | 17 | 68 |
|
Urine Uric Acid [units: Subjects] |
||||
| Underexcretor | 5 | 62 | 21 | 88 |
| Overproducer | 3 | 16 | 7 | 26 |
| Missing | 0 | 1 | 1 | 2 |
|
Body Mass Index [units: kiligram per meter² (kg/m²)] Mean ± Standard Deviation |
28.4 ± 2.78 | 32.9 ± 5.28 | 33.9 ± 6.82 | 32.9 ± 5.69 |
|
Serum Urate [units: mg/dL] Mean ± Standard Deviation |
9.58 ± 1.18 | 9.48 ± 1.04 | 10.23 ± 1.74 | 9.7 ± 1.30 |
| [1] | Impaired renal function was defined as serum creatinine >1.5 milligrams per deciliter (mg/dL) or a creatinine clearance of ≤80 milliliters per minute (mL/min) |
|---|
Outcome Measures
| 1. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. |
| 2. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. |
| 3. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. |
| 4. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. |
| 5. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. |
| 6. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. |
| 7. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. |
| 8. Primary: | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. |
| 9. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. |
| 10. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. |
| 11. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. |
| 12. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. |
| 13. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. |
| 14. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. |
| 15. Secondary: | Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. |
| 16. Secondary: | Percent Change in Serum Urate Levels From Baseline at Final Visit. |
More Information
| 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. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
| Study ID Numbers: | TMX-01-005 |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 12, 2009 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00174941 History of Changes |
| Health Authority: | United States: Food and Drug Administration |