NCT05767346

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Conditions

• Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

Type	Name	Description
DRUG	Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)	Aficamten (CK-3773274) tablets administered orally
DRUG	Placebo to match aficamten	Placebo for aficamten (CK-3773274) administered orally
DRUG	Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)	Metoprolol succinate tablets administered orally
DRUG	Placebo to match metoprolol succinate	Placebo for metoprolol succinate administered orally

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-02-28
• Completion: 2025-03-28
• First posted: 2023-03-14
• Last updated: 2025-05-02

Locations

71 sites across 13 countries: United States, Brazil, Canada, China, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study