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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02104583 | Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator | PHASE2 | COMPLETED | 313 | — | — | Sep 1, 2014 | Oct 1, 2016 | Apr 9, 2019 | 84 | United States, Canada +7 |
| Arm | Type | Description |
|---|---|---|
| Eleclazine 3 mg | EXPERIMENTAL | Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months. |
| Eleclazine 6 mg | EXPERIMENTAL | Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months. |
| Name | Type | Description |
|---|---|---|
| Eleclazine | DRUG | Eleclazine tablets administered orally |
| Placebo to match eleclazine | DRUG | Placebo to match eleclazine tablets administered orally |
Key Inclusion Criteria: * Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) \[shock or ATP\] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within...