A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adolescents (Age 12 Years to < 18 Years) With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Status: Active_not_recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• Diagnosis of HCM
• Presence of LVOT obstruction
• Presence of symptoms
Locations
United States
Alabama
Local Institution - 0017
Birmingham
Arizona
Local Institution - 0050
Phoenix
California
Local Institution - 0008
Los Angeles
Local Institution - 0032
Los Angeles
Local Institution - 0033
Palo Alto
Local Institution - 0044
San Diego
Colorado
Local Institution - 0038
Aurora
Florida
Local Institution - 0031
St. Petersburg
Georgia
Local Institution - 0053
Atlanta
Illinois
Local Institution - 0013
Chicago
Indiana
Local Institution - 0009
Indianapolis
Massachusetts
Local Institution - 0043
Boston
Michigan
Local Institution - 0002
Ann Arbor
Missouri
Local Institution - 0037
St Louis
North Carolina
Local Institution - 0015
Charlotte
Local Institution - 0039
Durham
New Jersey
Local Institution - 0052
Morristown
New York
Local Institution - 0010
New Hyde Park
Local Institution - 0024
New York
Local Institution - 0036
New York
Local Institution - 0040
The Bronx
Ohio
Local Institution - 0019
Cincinnati
Local Institution - 0001
Cleveland
Local Institution - 0029
Columbus
Pennsylvania
Local Institution - 0030
Philadelphia
Local Institution - 0005
Pittsburgh
Tennessee
Local Institution - 0034
Memphis
Texas
Local Institution - 0045
Austin
Local Institution - 0054
Houston
Utah
Local Institution - 0003
Salt Lake City
Virginia
Local Institution - 0012
Charlottesville
Other Locations
Australia
Local Institution - 0042
Clayton
Local Institution - 0020
Sydney
Canada
Local Institution - 0041
Edmonton
Local Institution - 0046
Toronto
France
Local Institution - 0022
Paris
Local Institution - 0026
Pessac
Germany
Local Institution - 0018
Berlin
Local Institution - 0006
Munich
Ireland
Local Institution - 0047
Dublin 12, D12 N512
Italy
Local Institution - 0016
Florence
Local Institution - 0051
Genova
Local Institution - 0027
Napoli
Spain
Local Institution - 0014
Barcelona
Local Institution - 0025
Madrid
United Kingdom
Local Institution - 0049
Belfast
Local Institution - 0007
London
Time Frame
Start Date: 2024-04-17
Completion Date: 2031-03-28
Participants
Target number of participants: 40
Treatments
Experimental: Mavacamten
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.
Experimental: Placebo
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb