Effect of pemafibrate on vascular endothelial function estimated by flow-mediated dilatation in hyperlipidemia patients with type 2 diabetes mellitus; multicenter, randomized controlled, open label, ethyl icosapentate-controlled trial in Kagoshima (PARADISE in Kagoshima study) - PARADISE in Kagoshima study

ishio Yoshihiko0 个研究点目标入组 100 人开始时间: 2020年3月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients who meet all of the following criteria are included in this study:
•1.Patients with hyperlipidemia whose casual triglyceride is 175 mg/dL or higher, and 1000 mg/dL or lower, or whose fasting triglyceride is 150 mg/dL or higher, and 1000 mg/dL or lower.
•2.Patients who are diagnosed as type 2 diabetes mellitus, and whose carbohydrate metabolism is stable (difference in HbA1c of the latest two measures are less than 1%)
•3.Male and female aged 20 years or older, and younger than 80 years when giving their consent
•4.Patients who give their consent in a written form

•Patients who fall into any of the following criteria are excluded from participating in the study:
•1.Patients with type 1 diabetes mellitus
•2.Patients with unstable glycemic control (HbA1c in the latest 12 weeks is 9% or higher)
•3.Patients with renal impairment (serum creatinine is 1.5 mg/dL or higher)
•4.Patients with history of hypersensitivity against the study agent or the control agent, or who meet contraindication for the study agent or the control agent
•5.Patients who used fibrate within 4 weeks before giving their consent
•6.Patients who used omega-3 fatty acid or any supplements with same effect within 12 weeks before giving their consent
•7.Patients who used corticosteroid such as prednisolone within 12 weeks before giving their consent.
•Patients who used corticosteroid of 10mg/day or less, and whose disease status is stable, can be included.
•8.Patients who changed the usage or dose of hydroxymethylglutaryl-CoA reductase inhibitor or angiotensin receptor antagonist within 4 weeks before giving their consent
•9.Patients with cancer or who are treated with anticancer agent
•10.Patients with hemorrhage or hemorrhagic diathesis
•11.Patients with familial hypercholesterolemia
•12.Patients who are breastfeeding, pregnant, or possibly pregnant
•13.Patients who are participating in other interventional trials
•14.Patients with other conditions that the investigator or researcher thinks inappropriate for the study

发起方

ishio Yoshihiko