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Trial ID CV027-010  |   NCT06253221

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Summary

  • Phase 3
  • Male and Female Gender icon
  • 12-17
    Age Range
  • 48
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Diagnosis of HCM
    1. Presence of LVOT obstruction
      1. Presence of symptoms

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
          1. Evidence of LVEF <50% in prior 6 months
            1. Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase) Other protocol-defined Inclusion/Exclusion criteria apply.
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Mavacamten

              ASSIGNED INTERVENTION
              • Drug: Mavacamten

              Study Arms

              Experimental: Placebo

              ASSIGNED INTERVENTION
              • Drug: Placebo
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