None listed
Conditions
Interventions
Drug : Experimental : IMD-Omega soft capsule + Omacor soft capsule placebo, QD, Oral
Active comparator : IMD-Omega soft capsule placebo + Omacor soft capsule, QD, Oral
IMD-Omega soft capsule : Omega-3
Sponsors
IMDPharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of change in triglycerides | — |
Secondary
| Measure | Time frame |
|---|---|
| Variation and rate of change in Total cholesterol, HDL-C, non-HDL-C, TC/HDL-C Ratio, Apo B;Variation and rate of change in Triglyceride;Convenience in taking medication, degree of off-flavor | — |
Countries
Korea, Republic of
Contacts
Public Contactbelong cho
Seoul National University Hospital
Outcome results
None listed