- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344862
Study of FYU-981 in Hyperuricemia With or Without Gout
January 22, 2015 updated by: Fuji Yakuhin Co., Ltd.
Exploratory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIa) Study)
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
- Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Subjects randomized to the placebo arm receive placebo.
|
Active Comparator: FYU-981 High dose
|
Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
|
Active Comparator: FYU-981 Middle dose
|
Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
|
Active Comparator: FYU-981 Low dose
|
Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent reduction from baseline in serum urate level at the final visit
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
January 18, 2015
First Submitted That Met QC Criteria
January 22, 2015
First Posted (Estimate)
January 26, 2015
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 22, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FYU-981-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperuricemia
-
Lingling Yu (103250)Wuhan Integrated Traditional Chinese and Western Medicine Hospital; Xianning...Recruiting
-
Shanghai Institute Of Biological ProductsFirst Affiliated Hospital Bengbu Medical CollegeCompletedAsymptomatic HyperuricemiaChina
-
China Medical University HospitalUnknown"Hyperuricemia,Anserine"Taiwan
-
Sun Yat-sen UniversityRecruiting
-
China Medical University HospitalUnknownHyperuricemia, Anserine, PharmacokineticTaiwan
-
Hebei Medical UniversityCompletedHeart Failure, HyperuricemiaChina
-
AstraZenecaContract Research Organization: USA; PAREXEL Early Phase Clinical Unit Baltimore and other collaboratorsCompletedAsymptomatic HyperuricemiaUnited States
-
University of MinnesotaCompleted
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
Clinical Trials on FYU-981 High dose, (Oral daily dosing for 8 weeks)
-
Sanwa Kagaku Kenkyusho Co., Ltd.Fuji Yakuhin Co., Ltd.Completed
-
Fox Chase Cancer CenterWithdrawnNon-Small Cell Lung CancerUnited States
-
PfizerCompleted
-
Memorial Sloan Kettering Cancer CenterTufts Medical Center; Lahey ClinicCompleted
-
Memorial Sloan Kettering Cancer CenterCompletedNon-Hodgkin's Lymphoma | CNS Lymphoma | CNS Brain CancerUnited States