Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Allopurinol; Febuxostat

Criteria

Inclusion Criteria:

• Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).

• Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).

• Has participated in a clinical study in which febuxostat was administered.

• Is completing Phase 3 Studies C02-009 or C02-010.

• Must not have experienced any serious study drug-related adverse events in the previous study.

• 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:

• Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.

• Is intolerant of allopurinol.