Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
NCT05186818 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282
Last updated 2026-03-03
Summary
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.
Conditions
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
Interventions
- DRUG
-
Aficamten (5 mg, 10 mg, 15 mg, and 20 mg)
Aficamten tablets were administered orally once daily.
- DRUG
-
Placebo to match aficamten
Placebo tablets were administered orally once daily.
Sponsors & Collaborators
-
Corxel Pharmaceuticals
collaborator INDUSTRY -
Cytokinetics
lead INDUSTRY
Principal Investigators
-
Cytokinetics MD · Cytokinetics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2023-11-10
- Completion
- 2023-12-18
- FDA Drug
- Yes
Countries
- United States
- China
- Czechia
- Denmark
- France
- Germany
- Hungary
- Israel
- Italy
- Netherlands
- Poland
- Portugal
- Spain
- United Kingdom
Study Locations
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