A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
NCT ID: NCT03723655
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
282 participants
INTERVENTIONAL
2018-09-27
2026-01-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Active Treatment for participants with base target trough concentration
mavacamten
mavacamten capsules
Group 2
Active Treatment for participants with higher target trough concentration
mavacamten
mavacamten capsules
Group 3
Active Treatment for participants dose titrated to clinical response
mavacamten
mavacamten capsules
Interventions
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mavacamten
mavacamten capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0045
Scottsdale, Arizona, United States
Local Institution - 0058
Los Angeles, California, United States
Local Institution - 0066
San Francisco, California, United States
Local Institution - 0063
Stanford, California, United States
Local Institution - 0043
New Haven, Connecticut, United States
Local Institution - 0067
Jacksonville, Florida, United States
Local Institution - 0050
Chicago, Illinois, United States
Local Institution - 0070
Indianapolis, Indiana, United States
Local Institution - 0049
Iowa City, Iowa, United States
Local Institution - 0054
Boston, Massachusetts, United States
Local Institution - 0051
Ann Arbor, Michigan, United States
Local Institution - 0074
Grand Rapids, Michigan, United States
Local Institution - 0048
St Louis, Missouri, United States
Local Institution - 0060
New York, New York, United States
Local Institution - 0056
New York, New York, United States
Local Institution - 0071
Charlotte, North Carolina, United States
Local Institution - 0047
Durham, North Carolina, United States
Local Institution - 0052
Cincinnati, Ohio, United States
Local Institution - 0044
Portland, Oregon, United States
Local Institution - 0068
Bethlehem, Pennsylvania, United States
Local Institution - 0046
Philadelphia, Pennsylvania, United States
Local Institution - 0064
Pittsburgh, Pennsylvania, United States
Local Institution - 0073
Memphis, Tennessee, United States
Local Institution - 0061
Dallas, Texas, United States
Local Institution - 0055
Houston, Texas, United States
Local Institution - 0057
Houston, Texas, United States
Local Institution - 0072
Murray, Utah, United States
Local Institution - 0062
Salt Lake City, Utah, United States
Local Institution - 0053
Charlottesville, Virginia, United States
Local Institution - 0059
Richmond, Virginia, United States
Local Institution - 0065
Seattle, Washington, United States
Local Institution - 0002
Aalst, , Belgium
Local Institution - 0001
Brussels, , Belgium
Local Institution - 0003
Edegem, , Belgium
Local Institution - 0010
Prague, , Czechia
Local Institution - 0009
Prague, , Czechia
Local Institution - 0011
Aarhus, , Denmark
Local Institution - 0012
Frederiksberg, , Denmark
Local Institution - 0013
Odense, , Denmark
Local Institution - 0014
Nantes, , France
Local Institution - 0017
Paris, , France
Local Institution - 0016
Paris, , France
Local Institution - 0015
Toulouse, , France
Local Institution - 0020
Bad Nauheim, , Germany
Local Institution - 0018
Dresden, , Germany
Local Institution - 0019
Göttingen, , Germany
Local Institution - 0021
Heidelberg, , Germany
Local Institution - 0027
Jerusalem, , Israel
Local Institution - 0024
Petah Tikva, , Israel
Local Institution - 0022
Ramat Gan, , Israel
Local Institution - 0025
Rehovot, , Israel
Local Institution - 0023
Safed, , Israel
Local Institution - 0026
Tel Aviv, , Israel
Local Institution - 0028
Florence, , Italy
Local Institution - 0029
Maastricht, , Netherlands
Local Institution - 0030
Rotterdam, , Netherlands
Local Institution - 0033
Katowice, , Poland
Local Institution - 0034
Krakow, , Poland
Local Institution - 0031
Poznan, , Poland
Local Institution - 0032
Warsaw, , Poland
Local Institution - 0036
Almada, , Portugal
Local Institution - 0035
Lisbon, , Portugal
Local Institution - 0038
A Coruña, , Spain
Local Institution - 0037
El Palmar, , Spain
Local Institution - 0040
Madrid, , Spain
Local Institution - 0039
Majadahonda, , Spain
Local Institution - 0041
Seville, , Spain
Local Institution - 0042
London, , United Kingdom
Countries
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References
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Rader F, Oreziak A, Choudhury L, Saberi S, Fermin D, Wheeler MT, Abraham TP, Garcia-Pavia P, Zwas DR, Masri A, Owens A, Hegde SM, Seidler T, Fox S, Balaratnam G, Sehnert AJ, Olivotto I. Mavacamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: Interim Results From the MAVA-LTE Study, EXPLORER-LTE Cohort. JACC Heart Fail. 2024 Jan;12(1):164-177. doi: 10.1016/j.jchf.2023.09.028.
Related Links
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BMS Clinical Trial Information
Other Identifiers
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CV027-003
Identifier Type: -
Identifier Source: org_study_id
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