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

NCT05767346 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-05-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Scientific Leadership · Cytokinetics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-20
Primary Completion
2025-02-28
Completion
2025-03-28
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT05767346 on ClinicalTrials.gov