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Recruitment status Completed
Unique ID issued by UMIN UMIN000008900
Receipt No. R000010441
Scientific Title Effect of febuxostat on vascular endothelial function in patients with hyperuricemia
Date of disclosure of the study information 2012/09/11
Last modified on 2013/09/17

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

Condition
Condition hyperuricemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate clinical benefit of febuxostat on vascular endothelial function in patients with hyperuricemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes flow-mediated vasodilation
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
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 (+ nutrition education)
Interventions/Control_2 Control group (nutrition education)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hyperuricemic patients who's uric acid level is over 7.0mg/dL
Key exclusion criteria 1.Pregnant or nursing woman
2.Diabetic patients who's HbA1c(NGSP) is over 8.4%
3.Patients with having past history of allergic event
4.Patients with severe liver injury or severe renal insufficiency
5.Patients who's systolic blood pressure is over 160mmHg and/or diastolic blood pressure is over 110mmHg
6.Ineligible patients for any other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Mihara
Organization Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University
Division name Department of Molecular Endocrinology and Metabolism
Zip code
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-5216
Email mmihara.mem@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Ohashi
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Molecular Endocrinology and Metabolism
Zip code
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-5216
Homepage URL
Email dept.mem@tmd.ac.jp

Sponsor
Institute Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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 11 Day

Related information
URL releasing protocol
Publication of results Partially published

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 08 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 11 Day
Last modified on
2013 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010441


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