Study of FYU-981 in Hyperuricemia With or Without Gout

• Status: Completed
• Trial end date: 2018-10-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuji Yakuhin Co., Ltd.
• Collaborator: Mochida Pharmaceutical Company, Ltd.
• Treatments: Dotinurad

Criteria

Inclusion Criteria:

• Hyperuricemic or gout patients

• Serum urate level:

>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL

Exclusion Criteria:

• Gouty arthritis within two weeks before start of study treatment

• Secondary hyperuricemia

• HbA1c: >= 8.4%

• Uric acid-overproduction type in the classification of hyperuricemia

• History of, clinically significant cardiac, hematologic and hepatic disease

• Kidney calculi or clinically significant urinary calculi

• eGFR: < 30mL/min/1.73m^2

• Systolic blood pressure: >= 180 mmHg

• Diastolic blood pressure: >= 110 mmHg