UMIN-CTR Clinical Trial

Basic information
Public title	Effect of febuxisostat on serum uric acid levels and endothelial function in patients with hyperuricemia
Acronym	Effect of febuxisostat on serum uric acid levels and endothelial function in patients with hyperuricemia
Scientific Title	Effect of febuxisostat on serum uric acid levels and endothelial function in patients with hyperuricemia
Scientific Title:Acronym	Effect of febuxisostat on serum uric acid levels and endothelial 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	To compare effects of febuxostat and allopurinol on serum uric acid levels and endothelial function by Endo-PAT in patients with hyperuricemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	1) %change of serum uric acid levels 2) Endothelial function by Endo-PAT
Key secondary outcomes	1) Oxidative stress marker (ie. nitrotyrosine, ADMA and MDA-LDL) 2) Office blood pressure (Ambulatory Blood Pressure Monitoring in possible cases)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: Participants will be received 20mg/day of febuxostat for 12 weeks. After that participants will be received 100mg/day of allopurinol for 12 weeks without wasuout periods.
Interventions/Control_2	Group B: Participants will be received 100mg/day of allopurinol for 12 weeks. After that participants will be received 20mg/day of febuxostat for 12 weeks without wasuout periods.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with hyperuricemia who have treated with allopurinol and have serum uric acid levels of 7.0 mg/dL or higher. 2) Patients who have eGFR of 30 mL/min/1.73m2 or higher. 3) Patients who give informed consent.
Key exclusion criteria	1) Patients who have contraindication of febuxostat treatment. 2) Patients with secondary hyperuricemia. 3) Patient who have systolic blood pressure of 160mmHg or higher, or diastolic blood pressure of 100mgHg or higher. 4) Patients with AST and ALT elevation more than twice the institutional standard. 5) Patients who have had coronary heart disease and cerebrovascular disease within 6 months. 6) Patients treated with mercaptopurine hydrate or azathioprine 7) Breast-feeding woman 8) Patients judged to be unsuitable participants by physician-in-charge
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazunori Shimada
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email

Public contact
Name of contact person	1st name Middle name Last name Kazunori Shimada
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Homepage URL
Email

Sponsor
Institute	Department of Cardiovascular Medicine, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	None
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
Address
Tel
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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 09 Month 01 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	Open public recruiting
Date of protocol fixation	2012 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2014 Year 06 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 08 Month 23 Day
Last modified on	2013 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010282

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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