JPRN-jRCT2031220036
Recruiting
Phase 2
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase II Study)
Masahiko Fushimi0 sites30 target enrollmentApril 23, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hyperuricemic pediatric patients with or without gout
- Sponsor
- Masahiko Fushimi
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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