Overview

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