A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03723655|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : March 1, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy Obstructive Hypertrophic Cardiomyopathy Non-obstructive Hypertrophic Cardiomyopathy||Drug: mavacamten||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Site, Care Provider and Patients are blinded to study dose. Sponsor is now unblinded to study dose.|
|Official Title:||A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)|
|Actual Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||April 16, 2026|
|Estimated Study Completion Date :||April 16, 2026|
Experimental: Group 1
Active Treatment for participants with base target trough concentration
Other Name: MYK-461
Experimental: Group 2
Active Treatment for participants with higher target trough concentration
Other Name: MYK-461
Experimental: Group 3
Active Treatment for participants dose titrated to clinical response
Other Name: MYK-461
- Frequency and severity of treatment-emergent adverse events and serious adverse events [ Time Frame: 252 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included in this study pending MyoKardia Medical Monitoring approval) Participants who prematurely discontinued from the Parent Study or the MAVA-LTE study may be considered for inclusion.
- Has a body weight greater than 45 kg at the Screening Visit
- Has adequate acoustic windows to enable accurate TTEs.
- Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTE at rest.
- Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range).
- Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP).
In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).
Key Exclusion Criteria:
- Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II).
- Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit.
- Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the 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.
- History of clinically significant malignant disease that developed since enrollment in the Parent Study.
- Is unable to comply with the study requirements, including the number of required visits to the clinical site.
- Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723655
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
|Responsible Party:||Bristol-Myers Squibb|
|Other Study ID Numbers:||
|First Posted:||October 29, 2018 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Symptomatic, left ventricular outflow tract gradient
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases