Febuxostat-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: Febuxostat
- Registration Number
- NCT03372200
- Lead Sponsor
- Mochida Pharmaceutical Company, Ltd.
- Brief Summary
FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) 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
- 203
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-underexcretion type or mixed type
-
Outpatients
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Exclusion Criteria
- Gouty arthritis within 14 days before randomized allocation
- Secondary hyperuricemia
- HbA1c: >= 8.4%
- Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease
- Kidney calculi or clinically significant urinary calculi
- AST: >= 100 IU/L or ALT: >= 100 IU/L
- eGFR: < 30 mL/min/1.73m^2
- Systolic blood pressure: >= 180 mmHg or 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 - Febuxostat Febuxostat -
- 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)
Mochida Investigational sites
🇯🇵Tokyo, Japan