UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045426 |
|---|---|
| Receipt number | R000051866 |
| Scientific Title | Investigation of characteristics and prescription status and occurrence of cardiovascular and renal disease events in patients with hyperuricemia or gout |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2022/05/11 16:40:38 |
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Basic information
Public title
Investigation of characteristics and prescription status and occurrence of cardiovascular and renal disease events in patients with hyperuricemia or gout
Acronym
Investigation of various conditions in patients with hyperuricemia or gout
Scientific Title
Investigation of characteristics and prescription status and occurrence of cardiovascular and renal disease events in patients with hyperuricemia or gout
Scientific Title:Acronym
Investigation of various conditions in patients with hyperuricemia or gout
Region
| Japan |
Condition
Condition
Hyperuricemia or gout
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the specific characteristics and prescription status of individuals who were firstly diagnosed with hyperuricemia or gout, as well as the occurrence of cardiovascular and renal disease events, and to examine the impact of uric acid-lowering drugs on the occurrence of cardiovascular and renal events.
Basic objectives2
Others
Basic objectives -Others
Survey of actual conditions
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient characteristics and treatment status
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Database registrations within the total data period.
2. Continuing contract with the health insurance association in which they participated at the end of the total data period.
3. The first (oldest) diagnosis of hyperuricemia or gout (referred to as the index diagnosis) was within the inclusion period.
4. Twelve months of observations were available retrospectively from the time of the index diagnosis.
5. No record of ULD prescription prior to the index diagnosis.
6. Age over 20 years at the index diagnosis.
Key exclusion criteria
None
Target sample size
60000
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Akari |
Organization
Sanwa Kagaku Kenkyusho Co.,Ltd.
Division name
Medical Affairs Department
Zip code
461-8631
Address
35 Higashisotobori-cho,Higashi-ku, Nagoya
TEL
052-951-8130
s_akari@skk-net.com
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Akari |
Organization
Sanwa Kagaku Kenkyusho Co.,Ltd.
Division name
Medical Affairs Department
Zip code
461-8631
Address
35 Higashisotobori-cho,Higashi-ku, Nagoya
TEL
052-951-8130
Homepage URL
s_akari@skk-net.com
Sponsor or person
Institute
Medical Affairs Department, Sanwa Kagaku Kenkyusho Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sanwa Kagaku Kenkyusho Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
Sumitomo Shiba-Daimon Building 12F, 2-5-5 Shiba-Daimon, Minato-ku, Tokyo
Tel
03-5733-5010
rihds@jmdc.co.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
| 2021 | Year | 09 | Month | 10 | 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
64677
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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051866
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
