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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Active Treatment for participants with base target trough concentration |
|
| Group 2 | Experimental | Active Treatment for participants with higher target trough concentration |
|
| Group 3 | Experimental | Active Treatment for participants dose titrated to clinical response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mavacamten | Drug | mavacamten capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment-emergent adverse events and serious adverse events | 252 weeks |
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Key Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0045 | Scottsdale | Arizona | 85259 | United States | ||
| Local Institution - 0058 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38176782 | Derived | 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. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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Site, Care Provider and Patients are blinded to study dose. Sponsor is now unblinded to study dose.
| Los Angeles |
| California |
| 90027 |
| United States |
| Local Institution - 0066 | San Francisco | California | 94143 | United States |
| Local Institution - 0063 | Stanford | California | 94305 | United States |
| Local Institution - 0043 | New Haven | Connecticut | 06520-8017 | United States |
| Local Institution - 0067 | Jacksonville | Florida | 32224 | United States |
| Local Institution - 0050 | Chicago | Illinois | 60611 | United States |
| Local Institution - 0070 | Indianapolis | Indiana | 46260 | United States |
| Local Institution - 0049 | Iowa City | Iowa | 52242 | United States |
| Local Institution - 0054 | Boston | Massachusetts | 02115 | United States |
| Local Institution - 0051 | Ann Arbor | Michigan | 48109 | United States |
| Local Institution - 0074 | Grand Rapids | Michigan | 49503 | United States |
| Local Institution - 0048 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0060 | New York | New York | 10016 | United States |
| Local Institution - 0056 | New York | New York | 10032 | United States |
| Local Institution - 0071 | Charlotte | North Carolina | 28204 | United States |
| Local Institution - 0047 | Durham | North Carolina | 27710 | United States |
| Local Institution - 0052 | Cincinnati | Ohio | 45267 | United States |
| Local Institution - 0044 | Portland | Oregon | 97239 | United States |
| Local Institution - 0068 | Bethlehem | Pennsylvania | 18015 | United States |
| Local Institution - 0046 | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution - 0064 | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution - 0073 | Memphis | Tennessee | 38104 | United States |
| Local Institution - 0061 | Dallas | Texas | 75390 | United States |
| Local Institution - 0055 | Houston | Texas | 77030 | United States |
| Local Institution - 0057 | Houston | Texas | 77030 | United States |
| Local Institution - 0072 | Murray | Utah | 84107-5701 | United States |
| Local Institution - 0062 | Salt Lake City | Utah | 84112 | United States |
| Local Institution - 0053 | Charlottesville | Virginia | 22903 | United States |
| Local Institution - 0059 | Richmond | Virginia | 23298 | United States |
| Local Institution - 0065 | Seattle | Washington | 98195 | United States |
| Local Institution - 0002 | Aalst | 9300 | Belgium |
| Local Institution - 0001 | Brussels | 1070 | Belgium |
| Local Institution - 0003 | Edegem | 2650 | Belgium |
| Local Institution - 0010 | Prague | 128 08 | Czechia |
| Local Institution - 0009 | Prague | 140 21 | Czechia |
| Local Institution - 0011 | Aarhus | 8000 | Denmark |
| Local Institution - 0012 | Frederiksberg | 2000 | Denmark |
| Local Institution - 0013 | Odense | 5000 | Denmark |
| Local Institution - 0014 | Nantes | 44093 | France |
| Local Institution - 0017 | Paris | 75013 | France |
| Local Institution - 0016 | Paris | 75015 | France |
| Local Institution - 0015 | Toulouse | 31059 | France |
| Local Institution - 0020 | Bad Nauheim | 61231 | Germany |
| Local Institution - 0018 | Dresden | 01277 | Germany |
| Local Institution - 0019 | Göttingen | 37075 | Germany |
| Local Institution - 0021 | Heidelberg | 69120 | Germany |
| Local Institution - 0027 | Jerusalem | 9112001 | Israel |
| Local Institution - 0024 | Petah Tikva | 4941492 | Israel |
| Local Institution - 0022 | Ramat Gan | 52621 | Israel |
| Local Institution - 0025 | Rehovot | 76100 | Israel |
| Local Institution - 0023 | Safed | 13100 | Israel |
| Local Institution - 0026 | Tel Aviv | 6423906 | Israel |
| Local Institution - 0028 | Florence | 50139 | Italy |
| Local Institution - 0029 | Maastricht | 6229 HX | Netherlands |
| Local Institution - 0030 | Rotterdam | 3015 CE | Netherlands |
| Local Institution - 0033 | Katowice | 40-555 | Poland |
| Local Institution - 0034 | Krakow | 31-501 | Poland |
| Local Institution - 0031 | Poznan | 61-848 | Poland |
| Local Institution - 0032 | Warsaw | 04-628 | Poland |
| Local Institution - 0036 | Almada | 2805-267 | Portugal |
| Local Institution - 0035 | Lisbon | 1500-650 | Portugal |
| Local Institution - 0038 | A Coruña | 15006 | Spain |
| Local Institution - 0037 | El Palmar | 30120 | Spain |
| Local Institution - 0040 | Madrid | 28034 | Spain |
| Local Institution - 0039 | Majadahonda | 28222 | Spain |
| Local Institution - 0041 | Seville | 41009 | Spain |
| Local Institution - 0042 | London | W1G 8PH | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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