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Long-Term Safety and Efficacy of FYX-051 in Patients with Hyperuricemia (with or without Gout)

Long-Term Safety and Efficacy of FYX-051 in Patients with Hyperuricemia (with or without Gout)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221050
Enrollment
Unknown
Registered
2010-03-31
Start date
2010-03-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia and Gout

Interventions

investigational material(s) Generic name etc : FYX-051 INN of investigational material : Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Investigational mat

Sponsors

Fuji Yakuhin Co., Ltd.
Lead Sponsor
SANWA KAGAKU KENKYUSHO Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with hyperuricemia with the following serum urate level: - Serum urate level of >= 7.0mg/dL in patients with history of gout, or - Serum urate level of >= 8.0mg/dL in patients with renal stones, hypertension, hyperlipidemia or diabetes, or - Serum urate level of >= 9.0mg/dL

Exclusion criteria

Exclusion criteria: Patients with gouty arthritis within two weeks before start of study treatment Patients with secondary hyperuricemia Patients with, or a history of, clinically significant cardiac, hematologic and hepatic disease

Design outcomes

Primary

MeasureTime frame
Efficacy and Safety—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026