UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056031 |
|---|---|
| Receipt number | R000063278 |
| Scientific Title | Exploratory Study on the Anti-inflammatory Effects of Extended-Release Pemafibrate in Patients with Dyslipidemia |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2024/11/03 13:44:46 |
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Basic information
Public title
Anti-inflammatory Effects of Extended-Release Pemafibrate
Acronym
Anti-inflammatory Effects of Extended-Release Pemafibrate
Scientific Title
Exploratory Study on the Anti-inflammatory Effects of Extended-Release Pemafibrate in Patients with Dyslipidemia
Scientific Title:Acronym
Exploratory Study on the Anti-inflammatory Effects of Extended-Release Pemafibrate in Patients with Dyslipidemia
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study explores the anti-inflammatory and anti-oxidative effects of extended-release pemafibrate.
Basic objectives2
Others
Basic objectives -Others
Anti-inflammatory and anti-oxidative effects of extended-release pemafibrate
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in inflammatory markers from baseline at 24 weeks
Key secondary outcomes
Change in leukocyte count and differential count of leukocytes from baseline at 12 and 24 weeks
Change in liver and kidney function from baseline at 12 and 24 weeks
Change in serum lipids from baseline at 12 and 24 weeks
Change in other blood test parameters from baseline at 12 and 24 weeks
Change in oxidative stress markers from baseline at 24 weeks
Occurrence of cardiovascular events through the study period
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects include cases of dyslipidemia among patients who have visited the outpatient clinic or been admitted to the Second Department of Internal Medicine at the University of Occupational and Environmental Health Hospital. The study considers patients for whom treatment with pemafibrate XR is being evaluated, including those changing from other medications.
Key exclusion criteria
Patients who did not provide consent to participate in this study
Patients with a history of hypersensitivity to any component of this drug
Patients with severe hepatic impairment, cirrhosis classified as Child-Pugh B or C, or biliary obstruction
Patients with gallstones
Pregnant women or women who may be pregnant
Patients currently receiving cyclosporine or rifampicin
Any other patients deemed unsuitable for participation by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun-ichiro |
| Middle name | |
| Last name | Koga |
Organization
University of Occupational and Environmental Health, Japan
Division name
The Second Department of Internal Medicine
Zip code
8078555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, JAPAN
TEL
0936917436
j-koga@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun-ichiro |
| Middle name | |
| Last name | Koga |
Organization
University of Occupational and Environmental Health, Japan
Division name
The Second Department of Internal Medicine
Zip code
8078555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, JAPAN
TEL
0936917436
Homepage URL
j-koga@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Jun-ichiro Koga
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, JAPAN
Tel
0936031611
rinshokenkyu@mbox.clnc.uoeh-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 15 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Endpoint
Change in inflammatory markers from baseline at 24 weeks
Weeks are counted from the start of the pemafibrate XR.
Secondary Endpoints
Change in white blood cell count and white blood cell differential from baseline at 12 and 24 weeks
Change in liver and kidney function from baseline at 12 and 24 weeks
Change in blood lipid levels from baseline at 12 and 24 weeks
Change in other blood test parameters from baseline at 12 and 24 weeks
Change in oxidative stress markers from baseline at 24 weeks
Presence or absence of cardiovascular events by the end of the study period
Weeks are counted from the start of the pemafibrate XR.
Management information
Registered date
| 2024 | Year | 11 | Month | 03 | Day |
Last modified on
| 2024 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063278
