jRCT2041220061Active, not recruitingNot Applicable
A Study to Evaluate the Safety and Efficacy of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase III Study) (Extension 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
- No limit to No limit (—)
- Sex
- All
Inclusion Criteria
- •Hyperuricemic pediatric patients with or without gout, who completed the observation for 30 weeks of Study FYU-981-018 (jRCT2031220036).
Exclusion Criteria
- •Kidney calculi or clinically significant urinary calculi
- •Patients deemed inappropriate by the investigator to conduct this study
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
Similar Trials
Unknown
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