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Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3-acids ethylesters 90 4g, any statin | Experimental |
| |
| any statin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3-acids ethylesters 90 4g | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percent change of Triglyceride(TG) | from baseline at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percent change of Total Cholesterol(TC) | from baseline at week 16 | |
| The mean percent change of LDL-C | from baseline at week 16 | |
| The mean percent change of HDL-C |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St. Mary's Hospital | Bucheon-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32821712 | Derived | Son JW, Kim CH, Nam MS, Park IB, Yoo SJ. Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial. J Lipid Atheroscler. 2019 Sep;8(2):221-231. doi: 10.12997/jla.2019.8.2.221. Epub 2019 Jul 4. |
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| Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin |
| Drug |
|
| from baseline at week 16 |
| The mean percent change of HBA1c | from baseline at week 16 |
| The mean percent change of FPG | from baseline at week 16 |
| The mean percent change of hs-CRP | from baseline at week 16 |
| The mean percent change of PAI-1 | from baseline at week 16 |
| The mean percent change of Apolipoprotein A1 | from baseline at week 16 |
| The mean percent change of apolipoprotein B | from baseline at week 16 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| D019821 | Simvastatin |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D008148 | Lovastatin |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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