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| Name | Class |
|---|---|
| Daewon Pharmaceutical Co., Ltd. | INDUSTRY |
The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol) versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phytosterol esters of omega-3 | Experimental | 4 capsules/day for 12 weeks |
|
| Omega-3 acid ethyl esters | Active Comparator | 4 capsules/day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 acid ethyl esters | Other | 4 capsules/day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| fasting triglycerides levels | Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels | Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yossi Azuri, MD | Maccabi Healthcare Services, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maccabi Healthcare Services | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Phytosterol esters of omega-3 |
| Other |
4 capsules/day for 12 weeks |
|