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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04219826 | Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy | PHASE2 | COMPLETED | 96 | — | — | Jan 10, 2020 | Feb 28, 2023 | Feb 24, 2026 | 22 | United States, Italy +2 |
Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.
Participant incidence of LVEF \< 50% as assessed by the core laboratory assessment.
Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (oHCM) - Aficamten | EXPERIMENTAL | Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Cohort 1 (oHCM) - Placebo | PLACEBO_COMPARATOR | Participants received placebo once daily for up to 10 weeks |
| Cohort 2 (oHCM) - Aficamten | EXPERIMENTAL | Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Cohort 2 (oHCM) - Placebo | PLACEBO_COMPARATOR | Participants received placebo once daily for up to 10 weeks |
| Cohort 3 (oHCM) - Aficamten & Background Disopyramide | EXPERIMENTAL | Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide |
| Cohort 4 (nHCM) - Aficamten | EXPERIMENTAL | Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Name | Type | Description |
|---|---|---|
| CK-3773274 (5 - 15 mg) | DRUG | CK-3773274 tablets administered orally once daily |
| CK-3773274 (10 - 30 mg) | DRUG | CK-3773274 tablets administered orally once daily |
| Placebo for CK-3773274 | DRUG | Placebo administered orally once daily |
Inclusion Criteria * Males and females between 18 and 85 years of age at screening. * Body weight is ≥45 kg at screening. * Diagnosed with HCM per the following criteria: * Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease. * Has minimal ...