UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059728 |
|---|---|
| Receipt number | R000068309 |
| Scientific Title | A Before-and-After Study on the Impact of Switching from Conventional Icosapent Ethyl (EPA) Formulations to a Self-Emulsifying High-Purity EPA Formulation on Atherosclerotic Risk |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/10 21:00:48 |
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Basic information
Public title
A Before-and-After Study on the Impact of Switching from Conventional Icosapent Ethyl (EPA) Formulations to a Self-Emulsifying High-Purity EPA Formulation on Atherosclerotic Risk
Acronym
A Before-and-After Study on the Impact of Switching from Conventional Icosapent Ethyl (EPA) Formulations to a Self-Emulsifying High-Purity EPA Formulation on Atherosclerotic Risk
Scientific Title
A Before-and-After Study on the Impact of Switching from Conventional Icosapent Ethyl (EPA) Formulations to a Self-Emulsifying High-Purity EPA Formulation on Atherosclerotic Risk
Scientific Title:Acronym
A Before-and-After Study on the Impact of Switching from Conventional Icosapent Ethyl (EPA) Formulations to a Self-Emulsifying High-Purity EPA Formulation on Atherosclerotic Risk
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effects of switching from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation on atherosclerosis markers and peripheral nerve function in patients with dyslipidemia, using a six-month before-and-after comparison.
Basic objectives2
Others
Basic objectives -Others
Eicosapentaenoic acid ethyl ester (EPA) is widely used in the treatment of dyslipidemia and peripheral circulatory disorders, and its anti-atherosclerotic effects have been reported. However, conventional formulations have limitations in absorption and require multiple daily doses. To address these issues, a self-emulsifying high-purity EPA formulation has been developed. This new formulation offers improved absorption and the convenience of once-daily dosing, which is expected to enhance patient adherence. The present study aims to investigate the effects of switching from conventional EPA formulations to this new formulation on atherosclerosis risk and peripheral nerve function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in baPWV before and 6 months after switching from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In this study, patients will switch from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation (2 g once daily) and continue the treatment for six months.
Evaluations will be conducted at two time points: before the switch and six months after the switch.
The primary endpoint will be the change in brachial-ankle pulse wave velocity (baPWV), an indicator of atherosclerosis and peripheral circulation.
Secondary endpoints will include changes in serum lipid parameters (LDL-C, HDL-C, triglycerides, and non-HDL-C), subjective assessments of symptoms such as cold sensation, numbness, and pain, as well as evaluation of diabetic peripheral neuropathy using the DPN Check device and assessment of heart rate variability (CVR-R) on electrocardiography, to investigate the effects on autonomic and peripheral nerve function.
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 who have received a full explanation of the purpose and details of the study, have provided written informed consent, and are able to sign the consent form themselves.
Patients aged 18 years or older at the time of obtaining consent.
Patients who regularly visit the National Kokuritsu Kokubunji Medical Center and have been diagnosed with dyslipidemia.
Patients who have been continuously taking an existing eicosapentaenoic acid ethyl ester (EPA) formulation for at least four weeks.
Key exclusion criteria
Patients with a history of hypersensitivity to EPA formulations (eicosapentaenoic acid ethyl ester) or to any emulsifier components.
Patients currently taking mifepristone or misoprostol.
Patients who are continuously taking EPA-containing supplements or other omega-3 fatty acid preparations.
Patients with severe hepatic impairment (AST or ALT >= 3 times the upper limit of normal) or renal impairment (eGFR < 30 mL/min/1.73 m2).
Patients with unstable oral drug absorption due to gastrointestinal surgery or gastrointestinal malabsorption disorders.
Patients who are expected to have difficulty maintaining regular outpatient visits or adhering to the evaluation schedule due to transfer to another hospital or hospitalization during the study period.
Patients who are pregnant, breastfeeding, or considered by the investigator to have the potential for pregnancy during the study period.
Patients deemed by the principal investigator to be unsuitable for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Hakoshima |
Organization
National Kohnodai Medical Center, Japan Institute for Health Security
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
272-8516
Address
1-7-1 Kokubudai, Ichikawa-shi, Chiba, Japan
TEL
08049371016
mary.calla88@gmail.com
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hakoshima |
Organization
National Kohnodai Medical Center, Japan Institute for Health Security
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
272-8516
Address
1-7-1 Kokubudai, Ichikawa-shi, Chiba, Japan
TEL
047-372-3501
Homepage URL
mary.calla88@gmail.com
Sponsor or person
Institute
National Kohnodai Medical Center, Japan Institute for Health Security
Institute
Department
Personal name
Funding Source
Organization
Clinical research funding from Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Kohnodai Medical Center, Japan Institute for Health Security
Address
1-7-1 Kokubudai, Ichikawa-shi, Chiba, Japan
Tel
0473723501
hakoshima.m@jihs.go.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
| 2025 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 09 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068309
