UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009468 |
|---|---|
| Receipt number | R000011068 |
| Scientific Title | Effect of Febuxostat on vascular function in patients with hyperuricemia |
| Date of disclosure of the study information | 2012/12/04 |
| Last modified on | 2021/03/30 16:49:13 |
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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
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
uminchu-23-tomo@awa.bbiq.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Department of Cardiovascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011068
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