A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
Recruiting
Phase 2
Phase 3
Interventional Study
Pediatric
Symptomatic Obstructive Hypertrophic Cardiomyopathy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 17
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- Cytokinetics · Industry
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About This Trial
The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Period 1: Treatment Period
* Males and females between 12 and \< 18 years of age at screening and at Day 1.
* Body weight ≥ 45 kg for the initial cohort and then body weight ≥ 35 kg after at least 10 participants in the initial cohort have undergone dose titration up to W…
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