Status:
COMPLETED
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
1086 Patients enrolled
Trial Details
Trial ID
NCT00175019
Start Date
July 1 2003
End Date
February 1 2007
Last Update
July 27 2010
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