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

• Status: Completed
• Trial end date: 2018-07-05
• Target enrollment: 0
• Participant gender: All

Summary

FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) 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: Mochida Pharmaceutical Company, Ltd.
• Collaborator: Fuji Yakuhin Co., Ltd.
• Treatments: Dotinurad; Febuxostat

Criteria

Inclusion Criteria:

• Serum urate level:

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

• Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type

• Outpatients

Exclusion Criteria:

• Gouty arthritis within 14 days before randomized allocation

• Secondary hyperuricemia

• HbA1c: >= 8.4%

• Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease

• Kidney calculi or clinically significant urinary calculi

• AST: >= 100 IU/L or ALT: >= 100 IU/L

• eGFR: < 30 mL/min/1.73m^2

• Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg