Clinical test to examine the efficacy and safety of pemafibrate

Not Applicable

• Conditions: Hypertriglyceridemia

• Registration Number: JPRN-UMIN000047737
• Lead Sponsor: Department of Cardiology, Iwate Prefectural Centgral Hospital

Brief Summary

The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (-46.1% vs. -34.7%, p<0.001; 9.2% vs. 5.7%, p=0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-30
• Study Start: 2022-05-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1.patients who required additional medication for dyslipidemia during the study period 2.fasting serum TG levels of over than 1000 mg/dl 3.type 1 diabetes mellitus or uncontrolled type 2 DM (HbA1c level of over than 8.5%) 4.familiar hypercholesterolemia 5.chronic kidney disease showing a serum creatinine level of over than 1.5 mg/dL 6.history or complication of gallbladder disease, cholelithiasis, pancreatitis, and malignant tumor 7.aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation to a level more than two times the upper limit of normal (ULN) range 8.uncontrolled hypertension (systolic blood pressure BP ofover tahn 160 mmHg or diastolic BP of over than 100 mmHg) 9.hemoglobin level of less than 12g/dL in men or less than 11 g/dL in women 11.recent myocardial infarction or cerebrovascular disorder within 3 months before the study 12.hospitalization for worsening heart failure within 3 months 13.use of ezetimibe and supplements containing eicosapentaenoic acid, and/or docosahexaenoic acid within 3 months before the study. Patients were also prohibited from using agents that affect lipid metabolism,such as thiazolidinedione, insulin,oral corticosteroid, or protease inhibitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified