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Cardiac Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy

Phase 2 & 3
Waitlist Available
Research Sponsored by MyoKardia, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a body weight greater than 45 kg at the Screening Visit
Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP). In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).
Must not have
History of clinically significant malignant disease that developed since enrollment in the Parent Study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will enroll 2,400 participants with hypertrophic cardiomyopathy (HCM) to receive MYK-461 or placebo.

Who is the study for?
This trial is for adults over 45 kg who completed the MAVERICK-HCM or EXPLORER-HCM studies, have a left ventricular ejection fraction (LVEF) of ≥50%, and can undergo accurate heart scans. Women must not be pregnant, breastfeeding, and use effective birth control if sexually active. Exclusions include certain ECG abnormalities, recent serious cardiac events or arrhythmias, current treatment with specific drugs like disopyramide or ranolazine, significant other diseases that could affect study results or compliance.
What is being tested?
The study tests the long-term safety of Mavacamten in patients with Hypertrophic Cardiomyopathy who previously participated in related trials. It will take place across approximately 90 sites globally including some locations from previous studies to ensure continuity and reliability of data.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications treating cardiomyopathy may include dizziness, low blood pressure, heart rhythm problems, fatigue, shortness of breath among others. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh more than 45 kg.
Select...
I am not pregnant or breastfeeding and will use effective birth control during and 90 days after the trial.
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My heart's pumping ability is normal or above normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have developed a significant cancer since joining the initial study.

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

Side effects data

From 2020 Phase 3 trial • 251 Patients • NCT03470545
21%
Dizziness
15%
Dyspnoea
12%
Headache
12%
Nasopharyngitis
8%
Atrial Fibrillation
8%
Cough
8%
Back pain
8%
Upper respiratory tract infection
6%
Palpitations
6%
Syncope
6%
Fatigue
6%
Gastroesophageal reflux disease
6%
Arthralgia
4%
Diarrhoea
2%
Stress cardiomyopathy
2%
Angina pectoris
1%
Cardiac Failure
1%
Cardiogenic shock
1%
Pericardial effusion
1%
Systolic dysfunction
1%
Atrial septal defect
1%
Abdominal Pain
1%
Bacterial colitis
1%
Diverticulitis
1%
Infection
1%
Contusion
1%
Forearm Fracture
1%
SLE
1%
Ischaemic stroke
1%
Device inappropriate shock delivery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mavacamten (MYK-461)
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
Active Treatment for participants dose titrated to clinical response
Group II: Group 2Experimental Treatment1 Intervention
Active Treatment for participants with higher target trough concentration
Group III: Group 1Experimental Treatment1 Intervention
Active Treatment for participants with base target trough concentration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mavacamten
2018
Completed Phase 3
~360

Find a Location

Who is running the clinical trial?

MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
766 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,287 Total Patients Enrolled
Medical Information TeamStudy DirectorMyoKardia, Inc.
1 Previous Clinical Trials
251 Total Patients Enrolled

Media Library

Mavacamten (Cardiac Myosin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03723655 — Phase 2 & 3
Hypertrophic Cardiomyopathy Research Study Groups: Group 1, Group 2, Group 3
Hypertrophic Cardiomyopathy Clinical Trial 2023: Mavacamten Highlights & Side Effects. Trial Name: NCT03723655 — Phase 2 & 3
Mavacamten (Cardiac Myosin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03723655 — Phase 2 & 3
~130 spots leftby Mar 2030
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