← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1 and week 11

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1 and week 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1 and week 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 and week 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient

Secondary outcome measures

Area under the concentration-time curve (AUC)

Change from baseline in electrocardiogram (ECG) (QT interval)

Change from baseline in maximal wall thickness

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Participants assigned to this arm will receive mavacamten from week 28 to end of treatment at week 56.

Group II: MavacamtenExperimental Treatment1 Intervention

Participants assigned to this arm will receive mavacamten from day 1 to end of treatment at week 56.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Mavacamten

2022

Completed Phase 1

~340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,130,024 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals to participate in this clinical study?

"Patients aged between 12 and 17 with a confirmed diagnosis of hypertrophic cardiomyopathy are eligible for enrollment in this study, which aims to recruit 40 participants."

Answered by AI

Are new participants currently being enrolled in this ongoing medical study?

"As documented on clinicaltrials.gov, the ongoing medical trial is not in active pursuit of participants. The trial was first made public on February 15th, 2024 and had its latest update on February 2nd, 2024. Despite this specific study no longer seeking volunteers, there are currently 239 alternative trials actively enrolling patients."

Answered by AI

Do individuals younger than 35 years meet the criteria for participating in this study?

"Participants aged between 12 and 17 are sought for enrollment in this clinical study. There is a total of 30 investigations targeting individuals under the age of legal adulthood, while there are 208 trials designated for those above 65 years old."

Answered by AI

Has Mavacamten been granted approval by the FDA?

"Our team at Power has appraised the safety of Mavacamten as a 3 on our scale, aligning with this being a Phase 3 trial where efficacy data is present alongside multiple iterations of safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253221.

All > Hypertrophic Cardiomyopathy > Greensboro