Long-Term Safety of Febuxostat in Subjects With Gout.

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Febuxostat

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 <1.5 mg/dL).

• Must have completed four weeks of double-blind dosing in Study TMX-00-004.

• Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004.

• 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.

Exclusion Criteria:

• History of xanthinuria

• Alcohol consumption >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.