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Study of FYU-981 in Hyperuricemia With or Without Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03006445
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : December 6, 2018
Mochida Pharmaceutical Company, Ltd.
Information provided by (Responsible Party):
Fuji Yakuhin Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
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 : December 2016
Actual Primary Completion Date : August 23, 2018
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

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

Primary Outcome Measures :
  1. Percent reduction from baseline in serum urate level at the final visit [ Time Frame: 34 or 58 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03006445

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Tokyo, Japan
Sponsors and Collaborators
Fuji Yakuhin Co., Ltd.
Mochida Pharmaceutical Company, Ltd.

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Responsible Party: Fuji Yakuhin Co., Ltd. Identifier: NCT03006445     History of Changes
Other Study ID Numbers: FYU-981-010
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: September 2017
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes