A Study to Observe the Efficacy and Safety of Febuxostat in Subjects with Gout and Hyperuricemia
Phase 3
- Conditions
- Gout, Hyperuricemia
- Registration Number
- JPRN-jRCT2080222060
- Lead Sponsor
- Astellas Pharma China, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 594
Inclusion Criteria
Hyperuricemia with or without a history of gout
Exclusion Criteria
An attack of acute gouty arthritis at the time of the pre-assignment visit or the pre-administration visit, or subjects less than 2 weeks after recovery from a previous attack of gouty arthritis.
Severe hypertension or blood pressure not well controlled with antihypertensive agents without meeting the above criteria.
Hemoglobin A1c >= 8.4% or blood glucose not well controlled with hypoglycemic agents without meeting the above criteria.
Renal dysfunction.
Liver dysfunction.
Serious heart disease, any other serious diseases or history of drug-induced allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects with serum uric acid levels =< 6.0mg/dL<br>24w
- Secondary Outcome Measures
Name Time Method Mean percentage change from baseline in serum uric acid levels<br>24w