Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

Summary

FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

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

Details

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

• Hepatic dysfuction, or AST: >=100 IU/L or ALT: >=100 IU/L at the pre-examination

• eGFR: < 30mL/min/1.73m^2

• Systolic blood pressure: >= 180 mmHg

• Diastolic blood pressure: >= 110 mmHg