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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01242527 | Epanova® for Lowering Very High Triglycerides | PHASE2 | COMPLETED | 399 | — | — | Jan 1, 2011 | Apr 1, 2012 | Aug 4, 2016 | 68 | United States, Denmark +5 |
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | - |
| Epanova 2 g | EXPERIMENTAL | - |
| Epanova 3 g | EXPERIMENTAL | - |
| Epanova 4 g | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | 4 capsules (1g) daily for 12 weeks |
| omefas | DRUG | 2 capsules (1g) + 2 placebo daily for 12 weeks |
Inclusion Criteria: * Men or women, \>=18 years of age. * Very high serum TG values in the range \>=500 mg/dL and \<2000 mg/dL (\>=5.65 mmol/L and \<22.60 mmol/L) Exclusion Criteria: * Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish. * Known lipoprotein lipase im...