Multi-center, Randomized, Double-blinded, Active-controlled, 12-weeks, Non-inferiority phase 3 trial to Evaluate the Efficacy and Safety of IMD-Omega Soft Cap. in the complex (IIb) patients with hypertriglyceridemia and hypercholesterolemia

IMDPharm0 个研究点目标入组 240 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1) 19 = age < 80
•2) Anyone who voluntarily agrees to lifestyle management (e.g., dietary management, abstaining from alcohol and smoking) during the course of this clinical trial
•3) A person who agrees to discontinue medications (therapy) that may affect blood lipids, other than statins permitted as standard therapy during this clinical trial period and clinical trial medications

•1) Patients with uncontrolled hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg or more)
•2) A person who has been treated with a drug (therapy) that may affect blood lipids within four weeks at the time of screening is unable to perform a break and appropriate diet
•3) Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins
•4) A person who has a history of malignancy within 5 years from the time of screening
•5) Patients with acute arterial disease
•6) Those who have a history of myopathy, rhabdomyolysis (who have CPK more than twice the normal level), and those who have a history of muscle disease
•7) Severe renal impairment (blood creatinine more than twice the normal upper limit at screening time) or liver failure (AST or ALT more than twice the normal upper limit at screening time) or a history of bile congestion, patients with biliary obstruction
•8) A person who has a known hypersensitivity reaction to the ingredients of this clinical trial drug (e.g., fish oil, soft capsules)
•9) A person who is hypersensitive to the components of clinical trial drugs, statins, and statins
•10) A person whose body mass index exceeds 40 kg/m2

发起方

IMDPharm