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

Launched by TAKEDA · Sep 12, 2005

Keywords

ClinConnect Summary

Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 mg/dL), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often insufficient) risk factor for monosodium urate crystal deposition in tissues and is the fund...

Gender

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Eligibility 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.