UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058425 |
|---|---|
| Receipt number | R000066250 |
| Scientific Title | Study on the failure to achieve the target LDL cholesterol level in patients with dyslipidaemia -A study using DPC database- |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 16:32:52 |
* 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
Study on the failure to achieve the target LDL cholesterol level in patients with dyslipidaemia
Acronym
Study on the failure to achieve the target LDL cholesterol level in patients with dyslipidaemia
Scientific Title
Study on the failure to achieve the target LDL cholesterol level in patients with dyslipidaemia
-A study using DPC database-
Scientific Title:Acronym
Study on the failure to achieve the target LDL cholesterol level in patients with dyslipidaemia
-A study using DPC database-
Region
| Japan |
Condition
Condition
Dyslipidaemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The target LDL-C non-achievement rate and its actual situation will be clarified for each risk category defined based on JAS GL2022.
Basic objectives2
Others
Basic objectives -Others
The factors related to LDL-C target non-achievement for each risk category will be investigated.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients who did not achieve the target LDL-C level, which was higher than the target level
Key secondary outcomes
Odds ratios for each covariate in patient groups eligible for secondary prevention and high-risk primary prevention based on JAS GL2022.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older with dyslipidaemia who have LDL-C test results between 1 August 2022 and 31 March 2024.
Key exclusion criteria
N/A
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Maekawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Maekawa.Takuya.b@otsuka.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Maekawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Maekawa.Takuya.b@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
KitamachiShinryojo rinrishinsaiinkai
Address
1-1-3,KichijojiKitamachi,Musashino-si.Tokyo
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2025 | Year | 07 | 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
100000
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The target LDL-C non-achievement rate and its actual situation will be clarified for each risk category defined based on JAS GL2022.
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066250
