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

NCT04848506 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-01-22

No results posted yet for this study

Summary

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

Conditions

  • Symptomatic Hypertrophic Cardiomyopathy (HCM)

Interventions

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.

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Cytokinetics, MD · Cytokinetics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04848506 on ClinicalTrials.gov