Phase 2
Completed N=232
Long-Term Safety of Febuxostat in Subjects With Gout.
Source: ClinicalTrials.gov NCT00174941 ↗Enrolled (actual)
232
Serious AEs
15.0%
Results posted
Jul 2009
Primary outcomePrimary: Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. — 50; 93; 65; 82 percentage of subjects
Summary
The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. |
50; 93; 65; 82 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. |
57; 85; 67; 79 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. |
50; 82; 57; 74 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. |
63; 76; 92; 77 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. |
67; 84; 92; 84 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. |
83; 92; 85; 90 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. |
100; 93; 91; 93 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. |
100; 82; 81; 83 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. |
-35.9; -50.6; -47.6; -48.3 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. |
-35.0; -49.7; -49.3; -48.3 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. |
-35.5; -48.7; -39.5; -45.4 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. |
-38.9; -46.7; -54.7; -47.3 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. |
-43.0; -46.9; -56.4; -48.4 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. |
-50.0; -50.3; -53.8; -51.1 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. |
-45.5; -51.1; -59.0; -52.0 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline at Final Visit. |
-49.2; -47.1; -50.7; -48.1 | — |
Eligibility Criteria
Inclusion Criteria
- Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).
- Must meet American College of Rheumatology criteria for gout.
- Must have adequate renal function (serum creatinine 14/week
- Has a History of significant concomitant illness
- Has active liver disease.
- Has a body mass index greater than 50 kg/m2
- Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Data sourced from ClinicalTrials.gov (NCT00174941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.