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A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hypertriglyceridemia (OMEELVHT)
The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but \<2000 mg/dL).
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 240 |
| Start date | 2015-12 |
Conditions
- Hypertriglyceridemia
Interventions
- Omega-3-Acid Ethyl Esters 90 Soft Capsules
- Corn Oil
Primary outcomes
- End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions — 12 weeks