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Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM

NCT06081894 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-02-02

No results posted yet for this study

Summary

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.

Conditions

  • Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Interventions

DRUG

Aficamten

Oral Tablet

DRUG

Placebo

Oral Tablet

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Bayer

    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
2023-08-30
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT06081894 on ClinicalTrials.gov