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

Study results available
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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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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 NCT05186818 on ClinicalTrials.gov