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Active Not RecruitingNCT06253221

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

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adolescents (Age 12 Years to < 18 Years) With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Bristol-Myers Squibb · Industry
Sex
All
Age
12 Years – 17 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGMavacamtenSpecified dose on specified days
DRUGPlaceboSpecified dose on specified days

Timeline

Start date
2024-04-17
Primary completion
2025-11-25
Completion
2031-03-28
First posted
2024-02-12
Last updated
2025-12-19

Locations

47 sites across 9 countries: United States, Australia, Canada, France, Germany, Ireland, Italy, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT06253221. Inclusion in this directory is not an endorsement.

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy (NCT06253221) · Clinical Trials Directory