A Phase II Study of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout
- Conditions
- Hyperuricemic pediatric patients with or without gout
- Registration Number
- JPRN-jRCT2031220036
- Lead Sponsor
- Masahiko Fushimi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Hyperuricemic pediatric patients with or without gout
-Serum urate level:
>= 7.0 mg/dL in patients with history of gout, or
>= 8.0 mg/dL in patients complicated with kidney disease, hypertension, diabetes, metabolic syndrome or ischemic heart disease, or
>= 9.0 mg/dL in patients with not applicable the above
-Gouty arthritis within two weeks before start of study treatment
-Renal overload type of hyperuricemia
-HbA1c: >= 9.0%
-Clinically significant cardiac, and hepatic disease
-Kidney calculi or clinically significant urinary calculi
-eGFR: < 30 mL/min/1.73 m^2
-AST: >3xULN (upper limit of normal) or ALT: >3xULN
-Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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