A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Cardiomyopathy, Hypertrophic
Спонсор: Bristol-Myers Squibb
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Кой може да участва
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.