Status:
COMPLETED
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Lead Sponsor:
Mochida Pharmaceutical Company, Ltd.
Collaborating Sponsors:
Fuji Yakuhin Co., Ltd.
Conditions:
Hyperuricemia With or Without Gout
Eligibility:
MALE
20+ years
Phase:
PHASE1
Brief Summary
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatien...
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-overproduction type or Uric acid-underexcretion type
- Outpatients
Exclusion
- Gouty arthritis within 14 days before randomized allocation
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03375632
Start Date
January 4 2018
End Date
June 5 2018
Last Update
September 24 2018
Active Locations (1)
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1
Mochida Investigational sites
Tokyo, Japan