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Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of HCM
Presence of LVOT obstruction
Must not have
Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial aims to test how well mavacamten works, how safe it is, and how the body processes it in teenagers with a specific heart condition called obstructive hypertrophic cardiomyopathy.

Who is the study for?
This trial is for adolescents with obstructive hypertrophic cardiomyopathy (HCM) who show symptoms. Specific details about eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a specific level of disease severity.
What is being tested?
The study tests the effectiveness and safety of a drug called Mavacamten compared to a placebo in young patients with HCM. It also looks at how the body processes the drug.
What are the potential side effects?
While specific side effects are not listed, common ones for heart medications like Mavacamten could include dizziness, changes in blood pressure or heart rhythm, fatigue, and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with hypertrophic cardiomyopathy (HCM).
Select...
My heart has a blockage in the outflow tract.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart muscle thickening is not due to sarcomere dysfunction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.
Group II: MavacamtenExperimental Treatment1 Intervention
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavacamten
2022
Completed Phase 3
~530
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,481 Total Patients Enrolled
~27 spots leftby Feb 2028
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