Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061542) titled 'Retrospective observational study evaluating the efficacy and safety of pemafibrate extended-release formulation in patients with dyslipidemia' on June 1.
Study Type:
Observational
Primary Sponsor:
Institute - Meitetsu hospital
Condition:
Condition - Dyslipidemia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To retrospectively evaluate the effects of pemafibrate extended-release formulation on lipid profiles, hepatic function, renal function, body composition, liver stiffness parameters, and safety in patients with dyslipidemia treated in routine clinical practice.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Outpatients with dyslipidemia treated at our institution
Patients who initiated or switched to pemafibrate extended-release formulation
Patients with available follow-up data for at least 12 months
Key exclusion criteria - Patients referred to another hospital during the follow-up period
Patients who discontinued or self-discontinued pemafibrate extended-release formulation
Patients who underwent surgery, chemotherapy, radiotherapy, or immunotherapy for malignancy during the study period
Patients with primary lipid disorders
Patients with insufficient data required for analysis
Target Size - 100
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 04 Month 01 Day
Date of IRB - 2025 Year 04 Month 16 Day
Anticipated trial start date - 2025 Year 04 Month 01 Day
Last follow-up date - 2026 Year 04 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070424
Disclaimer: Curated by HT Syndication.
