Study of FYU-981 in Hyperuricemia With or Without Gout

Hyperuricemia Clinical Trial

Official title:

Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416167
• Other study ID #: FYU-981-006
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2015
• Last updated: February 13, 2017
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Fuji Yakuhin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• 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

• eGFR: < 30mL/min/1.73m^2

• Systolic blood pressure: >= 180 mmHg

• Diastolic blood pressure: >= 110 mmHg

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• FYU-981

• Placebo

Locations

Country	Name	City	State
Japan	Japan	Tokyo and Other Japanese City

Sponsors (1)

Lead Sponsor	Collaborator
Fuji Yakuhin Co., 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		12 weeks