Hypertrophic Cardiomyopathy > Mavacamten

Mavacamten for Hypertrophic Cardiomyopathy (ODYSSEY-HCM Trial)

Recruiting in Palo Alto (17 mi)

+500 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 9 jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called mavacamten to see if it is safe and effective for people with a heart condition that makes their heart muscle too thick. The goal is to help their heart work better and improve their symptoms.

Eligibility Criteria

This trial is for people with a heart condition called non-obstructive hypertrophic cardiomyopathy (nHCM). Participants should have significant thickening of the heart muscle, experience symptoms, and fall under specific classifications of heart function. They can't join if they've had unexplained fainting or dangerous irregular heartbeats recently, or if their condition might be due to another disease.

Participant Groups

The study is testing Mavacamten against a placebo to see if it's safe and effective for nHCM. Patients will randomly receive either the actual medication or a placebo without knowing which one they are taking.

Group I: Mavacamten Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Mavacamten is already approved in United States, European Union, Canada, Australia, Switzerland, Brazil for the following indications:

🇺🇸 Approved in United States as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

🇪🇺 Approved in European Union as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

🇨🇦 Approved in Canada as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

🇦🇺 Approved in Australia as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

🇨🇭 Approved in Switzerland as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

🇧🇷 Approved in Brazil as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Stern Cardiovascular Center. Pa Germantown, TN

Miami Research Group Miami, FL

Baptist Health Medical Center - Little Rock Little Rock, AR

University of Pennsylvania Philadelphia, PA

More Trial Locations

Who is running the clinical trial?

Bristol-Myers Squibb Lead Sponsor

References