Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01408303 | [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL | PHASE3 | COMPLETED | 646 | — | — | Aug 1, 2011 | Jun 1, 2012 | Dec 5, 2014 | 89 | United States |
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.
| Arm | Type | Description |
|---|---|---|
| Olive Oil | PLACEBO_COMPARATOR | olive oil: 4 g/day + prescription statin |
| Epanova, 2 g | EXPERIMENTAL | omega-3-carboxylic acids, 2g/day + prescription statin |
| Epanova, 4 g | EXPERIMENTAL | omega-3-carboxylic acids, 4g/day + prescription statin |
| Name | Type | Description |
|---|---|---|
| Olive oil, 4g | DRUG | Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin |
| omega-3-carboxylic acids, 2g | DRUG | Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin |
| omega-3-carboxylic acids, 4g | DRUG | Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin |
Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL. 3. The subject is a high risk for a future cardiovascular event. 4. The subject is treated with a statin and at or near LDL-C goal. Exclusion Criteria: 1. Allergy or intolerance t...