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Cardiac Myosin Inhibitor

Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (EXPLORER-HCM Trial)

Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

Eligible Conditions
  • Hypertrophic Cardiomyopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving A Clinical Response
Secondary study objectives
Change From Baseline to Week 30 in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score
Hypertrophic Cardiomyopathy
Change From Baseline to Week 30 in pVO2 as Assessed by CPET
+2 more

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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: mavacamten (MYK-461)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavacamten
FDA approved

Find a Location

Who is running the clinical trial?

MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
797 Total Patients Enrolled
Medical Information TeamStudy DirectorMyoKardia, Inc.
1 Previous Clinical Trials
282 Total Patients Enrolled
~33 spots leftby Dec 2025
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