Mavacamten for Hypertrophic Cardiomyopathy

Recruiting in Palo Alto (17 mi)

+159 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: MyoKardia, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 9 Jurisdictions

Trial Summary

What is the purpose of this trial?Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

Eligibility Criteria

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.

Inclusion Criteria

I weigh more than 45 kg.

Your blood and urine test results are within the normal range according to the lab's standards.

I am not pregnant or breastfeeding and will use effective birth control during and 90 days after the trial.

+3 more

Exclusion Criteria

Is unable to comply with the study requirements, including the number of required visits to the clinical site.

I have developed a significant cancer since joining the initial study.

Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.

+5 more

Participant Groups

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.

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

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

🇺🇸 Approved in United States as Camzyos for: