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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02145468 | A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60) | PHASE3 | COMPLETED | 3,503 | — | — | Jun 3, 2014 | Dec 14, 2015 | Jun 2, 2017 | 341 | United States, Argentina +32 |
The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.
| Arm | Type | Description |
|---|---|---|
| Losmapimod | EXPERIMENTAL | Losmapimod 7.5 mg twice daily oral tablet |
| Placebo | PLACEBO_COMPARATOR | Placebo twice daily oral tablet |
| Name | Type | Description |
|---|---|---|
| Losmapimod 7.5 mg twice daily | DRUG | Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets. |
| Placebo twice daily | DRUG | Subjects will receive placebo as film-coated, round, plain faced tablets. |
| Standard therapy | DRUG | Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy. |
Inclusion Criteria: * Signed written informed consent * Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy * Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI) * With the following timing of symptoms: NST...