A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Phase 3 – large-scale trial before approval
Conditions:
Cardiomyopathy, Hypertrophic
Sponsor: Bristol-Myers Squibb
trial.available_in:
БГ
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).
Who can participate
Inclusion Criteria:
* Diagnosis of HCM
* Presence of LVOT obstruction
* Presence of symptoms
Exclusion Criteria:
* Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
* Evidence of LVEF \<50% in prior 6 months
* Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase)
Other protocol-defined Inclusion/Exclusion criteria apply.
БГ