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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06081894 | Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM | PHASE3 | ACTIVE NOT_RECRUITING | 500 | — | — | Aug 30, 2023 | Sep 1, 2026 | Feb 2, 2026 | 180 | United States, Argentina +18 |
Effect of aficamten compared with placebo on participant health status
Effect of aficamten compared with placebo on maximal exercise capacity
| Arm | Type | Description |
|---|---|---|
| Aficamten | EXPERIMENTAL | Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of aficamten with dose levels guided by echocardiography assessments, for up to 72 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive placebo, for up to 72 weeks. |
| Name | Type | Description |
|---|---|---|
| Aficamten | DRUG | Oral Tablet |
| Placebo | DRUG | Oral Tablet |
Inclusion Criteria: * Between 18-85 years of age * Body mass index \< 40 kg/m2 * Diagnosed with nHCM and has a screening echocardiogram with the following: * End-diastolic left ventricular (LV) wall thickness: * ≥ 15 mm in one or more myocardial segments OR * ≥ 13 mm in one or more wall...