Study of FYU-981 in Hyperuricemia With or Without Gout

Hyperuricemia Clinical Trial

Official title:

Exploratory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIa) Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344862
• Other study ID #: FYU-981-003
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2015
• Last updated: January 22, 2015
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Fuji Yakuhin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is exploratory 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 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

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: < 60mL/min/1.73m^2

• Systolic blood pressure: >= 180 mmHg

• Diastolic blood pressure: >= 110 mmHg

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• FYU-981 High dose, (Oral daily dosing for 8 weeks)
Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
• FYU-981 Middle dose, (Oral daily dosing for 8 weeks)
Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
• FYU-981 Low dose, (Oral daily dosing for 8 weeks)
Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
• Placebo, (Oral daily dosing for 8 weeks)
Subjects randomized to the placebo arm receive placebo.

Locations

Country	Name	City	State
Japan	Japan	Tokyo

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		8 weeks	No