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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01047501 | Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) | PHASE3 | COMPLETED | 702 | — | — | Dec 1, 2009 | Feb 1, 2011 | Apr 25, 2022 | 80 | United States |
| NCT01047683 | Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL | PHASE3 | COMPLETED | 229 | — | — | Dec 1, 2009 | Jul 1, 2011 | Apr 25, 2022 | 60 | United States, Denmark +9 |
Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| AMR101 (ethyl icosapentate) - 2 g/day | EXPERIMENTAL | - |
| AMR101 (ethyl icosapentate) - 4 g/day | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMR101 (ethyl icosapentate) - 4 g/day | DRUG | AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks |
| AMR101 (ethyl icosapentate) - 2 g/day | DRUG | AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks |
| Placebo | DRUG | Placebo 4 capsules/day for 12 weeks |
Inclusion Criteria: * Men and women, ages \>18 * Fasting triglyceride ≥200 mg/dL and \<500 mg/dL * LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and \<100 mg/dL * High risk for coronary heart disease * On stable dose of statin (atorvastatin, rosuvastatin or simvastatin) * Provide written ...