UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009135 |
|---|---|
| Receipt number | R000010709 |
| Scientific Title | Assessment of relationship between serum uric acid levels and atherosclerosis |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2014/12/08 15:40:15 |
* 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
Assessment of relationship between serum uric acid levels and atherosclerosis
Acronym
Uric acid and atherosclerosis
Scientific Title
Assessment of relationship between serum uric acid levels and atherosclerosis
Scientific Title:Acronym
Uric acid and atherosclerosis
Region
| Japan |
Condition
Condition
hyperuricemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether serum uric acid is a risk factor for atherosclerosis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
association between surrogate markers of carotid atherosclerosis and serum uric acid levels
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) from 20 yr to 84 yr
2) both sexes
Key exclusion criteria
1) hypouricemic agent users
2) patients with severe renal and liver disorders
3) diuretics users
4) inadequate patients at a physician's discretion
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Aihara |
Organization
The University of Tokushima
Division name
Medicine and Bioregulatory Sciences
Zip code
Address
3-18-15 Kuramoto-cho Tokushima
TEL
088-633-7120
aihara@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Aihara |
Organization
The University of Tokushima, Graduate School of Health Biosciences
Division name
Medicine and Bioregulatory Sciences
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7120
Homepage URL
aihara@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Medicine and Bioregulatory Sciences
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Serum uric acid, other cardiovascular risk factors and carotid atherosclerosis are statistically evaluated .
Management information
Registered date
| 2012 | Year | 10 | Month | 17 | Day |
Last modified on
| 2014 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010709
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
