Study of FYU-981 in Hyperuricemia With or Without Gout

Hyperuricemia With or Without Gout Clinical Trial

Official title:

Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006445
• Other study ID #: FYU-981-010
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: October 24, 2018

Study information

• Verified date: September 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 of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 24, 2018
• Est. primary completion date: August 23, 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

• 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

Locations

Country	Name	City	State
n/a

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		34 or 58 weeks