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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01492361 | A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin | PHASE3 | COMPLETED | 8,179 | — | — | Nov 1, 2011 | May 1, 2018 | Apr 14, 2022 | 410 | United States, Australia +9 |
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
| Arm | Type | Description |
|---|---|---|
| AMR101 | EXPERIMENTAL | AMR101 (icosapent ethyl) + statin therapy, daily |
| Placebo | PLACEBO_COMPARATOR | Placebo + statin therapy, daily |
| Name | Type | Description |
|---|---|---|
| AMR101 | DRUG | Parallel Assignment |
| Placebo | DRUG | Parallel Assignment |
| Statin therapy | DRUG | Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL) |
Inclusion Criteria: * Men and non-pregnant or sterile women ages 45 and older * Hypertriglyceridemia * On statin therapy for at least four weeks * Either having established cardiovascular disease or at high risk for cardiovascular disease Exclusion Criteria: * Severe heart failure * Any life-thre...