UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060212 |
|---|---|
| Receipt number | R000068850 |
| Scientific Title | Pemafibrate-Low-Density Lipoprotein Cholesterol Intervention Study |
| Date of disclosure of the study information | 2026/01/12 |
| Last modified on | 2025/12/26 14:51:55 |
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Basic information
Public title
Pemafibrate-Low-Density Lipoprotein Cholesterol Intervention Study
Acronym
PEMA-LDL study
Scientific Title
Pemafibrate-Low-Density Lipoprotein Cholesterol Intervention Study
Scientific Title:Acronym
PEMA-LDL study
Region
| Japan |
Condition
Condition
hyperlipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effect of pemafibrate on LDL-C levels in patients with dyslipidemia who are receiving statin therapy, in a real-world clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in LDL-C from baseline at 24 weeks after initiation of pemafibrate treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older at the time of informed consent who were diagnosed with dyslipidemia
Individuals who had been treated with pemafibrate for at least 24 weeks after treatment initiation
Patients who had been receiving statin therapy for at least 12 weeks at the time of pemafibrate initiation and continued the statin without any change in type or dosage
Individuals with LDL-C>100 mg/dL at the time of pemafibrate initiation
Individuals with triglyceride (TG) levels <400 mg/dL at the time of pemafibrate initiation
Individuals who received an explanation regarding study participation, fully understood the study, and provided written informed consent of their own free will
Key exclusion criteria
Patients who meet any of the contraindications for pemafibrate
Patients who had addition of, or a change in the dosage of, lipid-lowering medications within 12 weeks prior to the initiation of pemafibrate
Patients who had addition of, or a change in the dosage of, oral steroid preparations, thyroid hormone preparations, or antithyroid drugs within 12 weeks prior to the initiation of pemafibrate
Patients who are otherwise judged by the investigator to be unsuitable for participation in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Maeda |
Organization
Kindai University Faculty of Medicine
Division name
Department of Endocrinology, Metabolism and Diabetes
Zip code
5900197
Address
1-14-1 Mihara-dai, Minami-ku, Osaka,
TEL
+81-72-288-7222
norikazu_maeda@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Hiromine |
Organization
Kindai University Faculty of Medicine
Division name
Department of Endocrinology, Metabolism and Diabetes
Zip code
5900197
Address
1-14-1 Mihara-dai, Minami-ku, Osaka,
TEL
+81-72-288-7222
Homepage URL
hiromine@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, 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
1-14-1 Mihara-dai, Minami-ku, Osaka,
Address
the institutional ethics committee of Kindai University Faculty of Medicine
Tel
+81-72-288-7222
zizen@med.kindai.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
近畿大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study(retrospective)
Management information
Registered date
| 2025 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068850
