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

Hyperuricemia With or Without Gout Clinical Trial

Official title:

Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100318
• Other study ID #: FYU-981-011
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Fuji Yakuhin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 31, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Gout
• Hyperuricemia
• Hyperuricemia With or Without Gout

Intervention

Drug:
• FYU-981
Oral daily dosing for 14 weeks
• Benzbromarone
Oral daily dosing for 14 weeks

Locations

Country	Name	City	State
Japan	Tokyo	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Fuji Yakuhin Co., Ltd.	Mochida Pharmaceutical Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction from baseline in serum urate level at the final visit	Percent reduction from baseline in serum urate level at the final visit	14 weeks