UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Febuxostat on vascular function in patients with hyperuricemia
Acronym	Effect of Febuxostat on vascular function in patients with hyperuricemia
Scientific Title	Effect of Febuxostat on vascular function in patients with hyperuricemia
Scientific Title:Acronym	Effect of Febuxostat on vascular function in patients with hyperuricemia
Region	Japan

Condition
Condition	hyperuricemia
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Febuxostat, a uric acid synthesis inhibitor, or Benzbromarone, a uricosuric drug, is administered to hyperuricemic patients (serum uric acid is greater than 8.0mg/dL with hypertension, ischemic heart disease, diabetes mellitus or metabolic syndrome, or serum uric acid is greater than 9.0mg/dL). After the serum uric acid level is controlled to 6.0mg/dL or less with these drugs, RHI (Reactive hyperemia index) by EndoPAT, an indicator of vascular function, and various biomarkers, such as ADMA, von Willebrand factor, endothelin-1, and VCAM-1 are measured in the patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of RHI measured by EndoPAT
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Febuxostat
Interventions/Control_2	Benzbromarone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hyperuricemia patients who meet the following criteria are enrolled; 1)Serum uric acid is greater than 8.0mg/dL with hypertension, ischemic heart disease, diabetes mellitus or metabolic syndrome, or serum uric acid is greater than 9.0mg/dL 2)Patients are required to the treatment of hyperuricemia 3)Age > 40 years 4)Patients agree to participate in this study.
Key exclusion criteria	The patients who meet the following criteria are excluded; 1)Patients will not take Febuxostat or Benzbromarone more than three months. 2)Frequent changes of concomitant medications are expected. 3)Patients with severe renal failure(eGFR<30 mL/min/1.73m2) and/ or on dialysis. 4)Pregnant woman 5)Patients have problems of severe allergic diseases on clinical course, or have a history of serious side effects and/or hypersensitivity to these drugs. 6)The physician judges that patients are inappropriate to attend this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Memura
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Cardiovascular Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto Nagasaki Japan
TEL	095-819-7288
Email	uminchu-23-tomo@awa.bbiq.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Ikeda
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Cardiovascular Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto Nagasaki Japan
TEL	095-819-7288
Homepage URL
Email	uminchu-23-tomo@awa.bbiq.jp

Sponsor
Institute	Nagasaki University Graduate School of Biomedical Sciences Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Nagasaki University Graduate School of Biomedical Sciences Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Graduate School of Biomedical Sciences
Address	1-7-1 Sakamoto Nagasaki Japan
Tel	095-819-7217
Email	mh_shomu@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 26 Day
Date of IRB	2012 Year 11 Month 26 Day
Anticipated trial start date	2012 Year 12 Month 04 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 03 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011068