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-981Drug: 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
Group Intervention Description FYU-981 FYU-981 - Benzbromarone Benzbromarone -
- Primary Outcome Measures
Name Time Method Percent reduction from baseline in serum urate level at the final visit 14 weeks Percent reduction from baseline in serum urate level at the final visit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tokyo
🇯🇵Tokyo, Japan