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
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009700
- Lead Sponsor
- IMDPharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the rate of change in triglycerides
- Secondary Outcome Measures
Name Time Method 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