Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

• Status: Completed
• Trial end date: 2018-06-05
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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-overproduction type or Uric acid-underexcretion type

• Outpatients

Exclusion Criteria:

• Gouty arthritis within 14 days before randomized allocation