NCT04848506

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Conditions

• Symptomatic Hypertrophic Cardiomyopathy (HCM)

Interventions

Type	Name	Description
DRUG	Aficamten (5 - 20 mg)	Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.

Timeline

• Start date: 2021-05-06
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2021-04-19
• Last updated: 2026-01-22

Locations

129 sites across 19 countries: United States, Argentina, Australia, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study