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UMIN ID: UMIN000056031

Registered date:15/11/2024

Anti-inflammatory Effects of Extended-Release Pemafibrate

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Dyslipidemia
Date of first enrollment	2024/06/18
Target sample size	50
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	Change in inflammatory markers from baseline at 24 weeks
Secondary Outcome	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

Primary Outcome

Change in inflammatory markers from baseline at 24 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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

Related Information

Primary Sponsor	University of Occupational and Environmental Health, Japan
Secondary Sponsor
Source(s) of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology
Secondary ID(s)

Contact

public contact
Name	Jun-ichiro Koga
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, JAPAN Japan 8078555
Telephone	0936917436
E-mail	j-koga@med.uoeh-u.ac.jp
Affiliation	University of Occupational and Environmental Health, Japan The Second Department of Internal Medicine
scientific contact
Name	Jun-ichiro Koga
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, JAPAN Japan
Telephone	0936917436
E-mail	j-koga@med.uoeh-u.ac.jp
Affiliation	University of Occupational and Environmental Health, Japan The Second Department of Internal Medicine

TO Original Data: UMIN