Status:
COMPLETED
Long-Term Safety of Febuxostat in Subjects With Gout.
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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.
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 milligrams per deciliter \[mg/dL\...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00174941
Start Date
March 1 2001
End Date
December 1 2006
Last Update
January 27 2011
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