UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008753 |
|---|---|
| Receipt number | R000010282 |
| Scientific Title | Effect of febuxisostat on serum uric acid levels and endothelial function in patients with hyperuricemia |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2022/09/13 09:22:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Kazunori |
| Middle name | |
| Last name | Shimada |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-0033
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
tetsuro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Shimada |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-0033
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tetsuro@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Juntendo University School of Medicine
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiovascular Medicine, Juntendo University School of Medicine
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
tetsuro@juntendo.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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
10
Results
N/A
Results date posted
| 2022 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
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
| 2022 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010282
