A prospective, single-arm, multicenter, investigator-initiated, interventional study to evaluate the efficacy and safety of switching from low- and moderate-intensity statin to Ezetimibe 10 mg and ROsuvastatIn 2.5 mg CombinAtion therapy in patients with type 2 diabetes mellitus with dyslipidemia. (EROICA)

Hanyang University Guri Hospital0 个研究点目标入组 665 人开始时间: 待定最近更新: 2023年3月6日

试验速览

暂无简介。

•1. Adults over the age of 19
•2. Patients diagnosed with type 2 diabetes
•3. Patients with dyslipidemia who have been taking a single drug of less than moderate strength for at least 12 weeks
•4. Patients with LDL-C =70 mg/dL and HbA1c <9% before enrollment
•5. Patients with diabetes for more than 10 years or with one or more of the major cardiovascular risk factors*
•(*: age (male =45 years, female =55 years), family history of early cardiovascular disease, high blood pressure, smoking, low HDL cholesterol)
•6. Patients who voluntarily gave written consent to participate in this study

•1. Patients who fall under the contraindications of the precautions for use of the drug for this study
•(1) Patients with hypersensitivity to the main ingredient or components of this drug
•(2) Patients with active liver disease
•(3) Myopathy patients
•(4) Patients taking cyclosporine concomitantly
•(5) Patients with severe renal impairment (creatinine clearance (CrCL) < 30 mL/min)
•2. Pregnant or possibly pregnant women and lactating women
•3. Patients who were judged inappropriate under the judgment of the researcher because they fall under the cautious administration category of this drug
•4. Patients judged unsuitable for participation in this study by other researchers

发起方