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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 260 weeks

Awards & highlights

PIONEER-OLE Trial Summary

This trial will study the effects of mavacamten in patients with a history of symptomatic obstructive HCM.

Eligible Conditions

Hypertrophic Cardiomyopathy

PIONEER-OLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 260 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 260 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 260 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency and severity of adverse events and serious adverse events.

Side effects data

From 2020 Phase 3 trial • 251 Patients • NCT03470545

21%

Dizziness

15%

Dyspnoea

12%

Nasopharyngitis

12%

Headache

Back pain

Upper respiratory tract infection

Atrial Fibrillation

Cough

Gastroesophageal reflux disease

Arthralgia

Palpitations

Syncope

Fatigue

Diarrhoea

Stress cardiomyopathy

Angina pectoris

Cardiac Failure

Bacterial colitis

Systolic dysfunction

Diverticulitis

Cardiogenic shock

Device inappropriate shock delivery

SLE

Ischaemic stroke

Pericardial effusion

Atrial septal defect

Infection

Contusion

Forearm Fracture

Abdominal Pain

100%

80%

60%

40%

20%

Study treatment Arm

Mavacamten (MYK-461)

Placebo

PIONEER-OLE 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

~330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,501 Total Patients Enrolled

MyoKardia, Inc.Lead Sponsor

12 Previous Clinical Trials

1,040 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

Frequently Asked Questions

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

Is this research fresh or has it been done before?

"5 international studies are ongoing for mavacamten as of right now. The initial clinical trial was completed in 2018 and sponsored by MyoKardia, Inc. That particular study only involved 13 patients and stopped at the Phase 2 stage of drug approval. 3 more trials have been completed since then."

Answered by AI

Has mavacamten undergone the FDA's rigorous approval process?

"While there is some data supporting mavacamten's safety, there is currently no evidence that the medication is effective. Consequently, it received a score of 2."

Answered by AI

Are there other drugs like mavacamten that have been trialed before?

"Currently, there are 5 ongoing studies involving mavacamten. 3 of those clinical trials are in the third and final phase. The majority of the research being conducted on mavacamten is based in Durham, North carolina; however, there are 198 total locations running trials for this medication."

Answered by AI

Can new participants still enroll in this experiment?

"Although this specific clinical trial is no longer recruiting patients (last updated June 10th, 2022), there are still many other opportunities to participate in similar research (239 active clinical trials as of now)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

2018. "Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03496168.