jRCT2031220036Active, not recruitingNot Applicable
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase II Study)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- FUJI YAKUHIN CO., LTD.
- Enrollment
- 30
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 6age old over to 18age old under (—)
- Sex
- All
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
-
Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration
Secondary Outcomes
No secondary outcomes reported
Investigators
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