A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified January 2026 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT03723655
Other Study ID Numbers:
CV027-003
First Submitted
October 23, 2018
First Posted
October 28, 2018
Last Update Posted
February 19, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hypertrophic CardiomyopathyObstructive Hypertrophic CardiomyopathyNon-obstructive Hypertrophic Cardiomyopathy
Drug: mavacamtenDrug: mavacamtenDrug: mavacamten

Study Design

Study TypeInterventional
Actual Enrollment314 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateSeptember 26, 2018
Actual Primary Completion DateJanuary 15, 2026
Actual Study Completion DateJanuary 15, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Group 1
Active Treatment for participants with base target trough concentration
Drug: mavacamten
mavacamten capsules
Group 2
Active Treatment for participants with higher target trough concentration
Drug: mavacamten
mavacamten capsules
Group 3
Active Treatment for participants dose titrated to clinical response
Drug: mavacamten
mavacamten capsules

Outcome Measures

Primary Outcome Measures
  1. Frequency and severity of treatment-emergent adverse events and serious adverse events

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0045 | Scottsdale Arizona, United States, 85259Local Institution - 0058 | Los Angeles California, United States, 90027Local Institution - 0066 | San Francisco California, United States, 94143Local Institution - 0063 | Stanford California, United States, 94305Local Institution - 0043 | New Haven Connecticut, United States, 06520-8017Local Institution - 0067 | Jacksonville Florida, United States, 32224Local Institution - 0050 | Chicago Illinois, United States, 60611Local Institution - 0070 | Indianapolis Indiana, United States, 46260Local Institution - 0049 | Iowa City Iowa, United States, 52242Local Institution - 0054 | Boston Massachusetts, United States, 02115Local Institution - 0051 | Ann Arbor Michigan, United States, 48109Local Institution - 0074 | Grand Rapids Michigan, United States, 49503Local Institution - 0048 | St Louis Missouri, United States, 63110Local Institution - 0060 | New York New York, United States, 10016Local Institution - 0056 | New York New York, United States, 10032Local Institution - 0071 | Charlotte North Carolina, United States, 28204Local Institution - 0047 | Durham North Carolina, United States, 27710Local Institution - 0052 | Cincinnati Ohio, United States, 45267Local Institution - 0044 | Portland Oregon, United States, 97239Local Institution - 0068 | Bethlehem Pennsylvania, United States, 18015Local Institution - 0046 | Philadelphia Pennsylvania, United States, 19104Local Institution - 0064 | Pittsburgh Pennsylvania, United States, 15213Local Institution - 0073 | Memphis Tennessee, United States, 38104Local Institution - 0061 | Dallas Texas, United States, 75390Local Institution - 0055 | Houston Texas, United States, 77030Local Institution - 0057 | Houston Texas, United States, 77030Local Institution - 0072 | Murray Utah, United States, 84107-5701Local Institution - 0062 | Salt Lake City Utah, United States, 84112Local Institution - 0053 | Charlottesville Virginia, United States, 22903Local Institution - 0059 | Richmond Virginia, United States, 23298Local Institution - 0065 | Seattle Washington, United States, 98195Local Institution - 0002 | Aalst , Belgium, 9300Local Institution - 0001 | Brussels , Belgium, 1070Local Institution - 0003 | Edegem , Belgium, 2650Local Institution - 0010 | Prague , Czechia, 128 08Local Institution - 0009 | Prague , Czechia, 140 21Local Institution - 0011 | Aarhus , Denmark, 8000Local Institution - 0012 | Frederiksberg , Denmark, 2000Local Institution - 0013 | Odense , Denmark, 5000Local Institution - 0014 | Nantes , France, 44093Local Institution - 0017 | Paris , France, 75013Local Institution - 0016 | Paris , France, 75015Local Institution - 0015 | Toulouse , France, 31059Local Institution - 0020 | Bad Nauheim , Germany, 61231Local Institution - 0018 | Dresden , Germany, 01277Local Institution - 0019 | Göttingen , Germany, 37075Local Institution - 0021 | Heidelberg , Germany, 69120Local Institution - 0027 | Jerusalem , Israel, 9112001Local Institution - 0024 | Petah Tikva , Israel, 4941492Local Institution - 0022 | Ramat Gan , Israel, 52621Local Institution - 0025 | Rehovot , Israel, 76100Local Institution - 0023 | Safed , Israel, 13100Local Institution - 0026 | Tel Aviv , Israel, 6423906Local Institution - 0028 | Florence , Italy, 50139Local Institution - 0029 | Maastricht , Netherlands, 6229 HXLocal Institution - 0030 | Rotterdam , Netherlands, 3015 CELocal Institution - 0033 | Katowice , Poland, 40-555Local Institution - 0034 | Krakow , Poland, 31-501Local Institution - 0031 | Poznan , Poland, 61-848Local Institution - 0032 | Warsaw , Poland, 04-628Local Institution - 0036 | Almada , Portugal, 2805-267Local Institution - 0035 | Lisbon , Portugal, 1500-650Local Institution - 0038 | A Coruña , Spain, 15006Local Institution - 0037 | El Palmar , Spain, 30120Local Institution - 0040 | Madrid , Spain, 28034Local Institution - 0039 | Majadahonda , Spain, 28222Local Institution - 0041 | Seville , Spain, 41009Local Institution - 0042 | London , United Kingdom, W1G 8PH
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb