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Cardiac Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy (PIONEER-OLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial involves giving mavacamten to patients with a specific heart condition called obstructive hypertrophic cardiomyopathy (oHCM). Mavacamten helps the heart muscle relax, improving blood flow and reducing symptoms. It has been shown to improve exercise capacity and relieve symptoms of oHCM.

Eligible Conditions
  • Hypertrophic Cardiomyopathy

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

1Treatment groups
Experimental Treatment
Group I: mavacamten (MYK-461)Experimental Treatment1 Intervention
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?

Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,575 Total Patients Enrolled
MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
1,035 Total Patients Enrolled
MyoKardia Medical Information TeamStudy DirectorMyoKardia, Inc.

Media Library

Mavacamten (Cardiac Myosin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03496168 — Phase 2
Hypertrophic Cardiomyopathy Research Study Groups: mavacamten (MYK-461)
Hypertrophic Cardiomyopathy Clinical Trial 2023: Mavacamten Highlights & Side Effects. Trial Name: NCT03496168 — Phase 2
Mavacamten (Cardiac Myosin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496168 — Phase 2
~2 spots leftby Dec 2025
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