Study of FYU-981 in Hyperuricemia With or Without Gout

• Sponsor: Fuji Yakuhin Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03006445
• Collaborator: Mochida Pharmaceutical Company, Ltd. (Industry)
• Enrollment: 330
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.7
• Patients Per Site Per Month: 14.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia With or Without Gout	Drug: FYU-981	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Aug 23, 2018
• Actual Study Completion Date: Oct 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FYU-981	Drug: FYU-981

Outcome Measures

Primary Outcome Measures

1. Percent reduction from baseline in serum urate level at the final visit [34 or 58 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tokyo		Japan

Sponsors and Collaborators

• Fuji Yakuhin Co., Ltd.
• Mochida Pharmaceutical Company, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fuji Yakuhin Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03006445
• Other Study ID Numbers: FYU-981-010
• First Posted: Dec 30, 2016
• Last Update Posted: Dec 6, 2018
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Gout; Hyperuricemia; Dotinurad

Study Results

No Results Posted as of Dec 6, 2018