A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
NCT ID: NCT06253221
Last Updated: 2025-12-19
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
PHASE3
44 participants
INTERVENTIONAL
2024-04-17
2031-03-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mavacamten
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.
Mavacamten
Specified dose on specified days
Placebo
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.
Placebo
Specified dose on specified days
Interventions
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Mavacamten
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of LVOT obstruction
* Presence of symptoms
Exclusion Criteria
* Evidence of LVEF \<50% in prior 6 months
* Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase)
12 Years
17 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 - 0017
Birmingham, Alabama, United States
Local Institution - 0050
Phoenix, Arizona, United States
Local Institution - 0032
Los Angeles, California, United States
Local Institution - 0008
Los Angeles, California, United States
Local Institution - 0033
Palo Alto, California, United States
Local Institution - 0044
San Diego, California, United States
Local Institution - 0038
Aurora, Colorado, United States
Local Institution - 0031
St. Petersburg, Florida, United States
Local Institution - 0053
Atlanta, Georgia, United States
Local Institution - 0013
Chicago, Illinois, United States
Local Institution - 0009
Indianapolis, Indiana, United States
Local Institution - 0043
Boston, Massachusetts, United States
Local Institution - 0002
Ann Arbor, Michigan, United States
Local Institution - 0037
St Louis, Missouri, United States
Local Institution - 0052
Morristown, New Jersey, United States
Local Institution - 0010
New Hyde Park, New York, United States
Local Institution - 0024
New York, New York, United States
Local Institution - 0036
New York, New York, United States
Local Institution - 0040
The Bronx, New York, United States
Local Institution - 0015
Charlotte, North Carolina, United States
Local Institution - 0039
Durham, North Carolina, United States
Local Institution - 0019
Cincinnati, Ohio, United States
Local Institution - 0001
Cleveland, Ohio, United States
Local Institution - 0029
Columbus, Ohio, United States
Local Institution - 0030
Philadelphia, Pennsylvania, United States
Local Institution - 0005
Pittsburgh, Pennsylvania, United States
Local Institution - 0034
Memphis, Tennessee, United States
Local Institution - 0045
Austin, Texas, United States
Local Institution - 0054
Houston, Texas, United States
Local Institution - 0003
Salt Lake City, Utah, United States
Local Institution - 0012
Charlottesville, Virginia, United States
Local Institution - 0020
Sydney, New South Wales, Australia
Local Institution - 0042
Clayton, Victoria, Australia
Local Institution - 0041
Edmonton, Alberta, Canada
Local Institution - 0046
Toronto, Ontario, Canada
Local Institution - 0022
Paris, , France
Local Institution - 0026
Pessac, , France
Local Institution - 0006
Munich, Bavaria, Germany
Local Institution - 0018
Berlin, State of Berlin, Germany
Local Institution - 0047
Dublin 12, D12 N512, , Ireland
Local Institution - 0016
Florence, FI, Italy
Local Institution - 0051
Genova, GE, Italy
Local Institution - 0027
Napoli, , Italy
Local Institution - 0014
Barcelona, B, Spain
Local Institution - 0025
Madrid, , Spain
Local Institution - 0049
Belfast, BFS, United Kingdom
Local Institution - 0007
London, , United Kingdom
Countries
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References
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Rossano J, Canter C, Wolf C, Favatella N, Lockman J, Puli S, Javidialsaadi A, Dyme J, Crevar C, Mital S. Mavacamten in symptomatic adolescent patients with obstructive hypertrophic cardiomyopathy: design of the phase 3 SCOUT-HCM trial. Am Heart J. 2025 Sep 30;292:107283. doi: 10.1016/j.ahj.2025.107283. Online ahead of print.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-505650-17-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-1175
Identifier Type: OTHER
Identifier Source: secondary_id
CV027-010
Identifier Type: -
Identifier Source: org_study_id