JPRN-jRCT2080222060
Unknown
Phase 3
A Phase III, Randomized, Double-blind, Double-dummy, Multi-center Clinical Study to Observe the Efficacy and Safety of Febuxostat Compared with Allopurinol in Subjects with Hyperuricemia (Including Gout)
ConditionsGout, Hyperuricemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Gout, Hyperuricemia
- Sponsor
- Astellas Pharma China, Inc.
- Enrollment
- 594
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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