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

Phase 3
Completed
Conditions
Hyperuricemia With or Without Gout
Interventions
Drug: FYU-981
Drug: Benzbromarone
Registration Number
NCT03100318
Lead Sponsor
Fuji Yakuhin Co., Ltd.
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
201
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

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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FYU-981FYU-981-
BenzbromaroneBenzbromarone-
Primary Outcome Measures
NameTimeMethod
Percent reduction from baseline in serum urate level at the final visit14 weeks

Percent reduction from baseline in serum urate level at the final visit

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tokyo

🇯🇵

Tokyo, Japan

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