UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006801 |
|---|---|
| Receipt number | R000007899 |
| Scientific Title | Effect of febuxostat on endothelial function: A randomized, open-label, parallel-group trial in patients with hyperuricemia |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2014/05/30 13:31:07 |
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Basic information
Public title
Effect of febuxostat on endothelial function: A randomized, open-label, parallel-group trial in patients with hyperuricemia
Acronym
Effect of febuxostat on endothelial function
Scientific Title
Effect of febuxostat on endothelial function: A randomized, open-label, parallel-group trial in patients with hyperuricemia
Scientific Title:Acronym
Effect of febuxostat on endothelial function
Region
| Japan |
Condition
Condition
Patients with hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of febuxostat, an inhibitor of xanthine oxidase, on endothelial function in patients with hyperuricemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
flow mediated vasodilation: FMD
Key secondary outcomes
1) Pulse wave velocity: PWV
2) Serum uric acid, Urinary uric acid excretion, Uric acid clearance
3) 8-oxodG, 8-epi-PGF2alpha, MDA, oxLDL
4) nitric oxide metabolite
5) serum XOR activity
6) FABP4
7) hsCRP, s-VCAM1
8) side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
febuxostat adoministration group
The patients with hyperuricemia (uric acid equal and more than 7 mg/dl) are treated with 10 mg/day of febuxostat for 14 days.
Interventions/Control_2
febuxostat non-adoministartion group
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) uric acid equal and more than 7 mg/dl
2) hospitalized patients
3) older than 19 years-old
4) without taking drugs lowered uric acid within 1 month before the informed consent acquisition
Key exclusion criteria
1) Patients who have liver injury.
2) renal replacement therapy
3) Patients who are having gouty arthritis (gout attack)
4) History of ischemic heart disease or cerebrovascular disease within 3 month before the informed consent acquisition
5) Pateients who had severe side effects or allergic recation to febuxostat
6) Patients who are taking mercaptopurine, azathioprine, vidarabine and didanosine
7) Patients who are judged as inadequate to participate in the study by their doctors.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Matsumura |
Organization
Graduate school of Kyushu university
Division name
Department of medicine and clinical science
Zip code
Address
Maidashi 3-1-1, HIgashi-ku, Fukuoka, Japan
TEL
092-642-5256
matsumk@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Ohtsubo |
Organization
Graduate school of Kyushu university
Division name
Department of medicine and clinical science
Zip code
Address
Maidashi 3-1-1, HIgashi-ku, Fukuoka, Japan
TEL
092-642-5256
Homepage URL
tohtsubo@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2014 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007899
