Status:
COMPLETED
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Lead Sponsor:
Mochida Pharmaceutical Company, Ltd.
Collaborating Sponsors:
Fuji Yakuhin Co., Ltd.
Conditions:
Hyperuricemia With or Without Gout
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2018
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03372200
Start Date
January 9 2018
End Date
July 5 2018
Last Update
September 24 2018
Active Locations (1)
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1
Mochida Investigational sites
Tokyo, Japan