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

Fuji Yakuhin

Status and phase

Completed

Phase 3

Conditions

Hyperuricemia With or Without Gout

Treatments

Drug: Benzbromarone

Drug: FYU-981

Study type

Interventional

Funder types

Industry

Identifiers

NCT03100318

FYU-981-011

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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