A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Last updated: December 18, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Circulation Disorders

Treatment

Placebo

Mavacamten

Clinical Study ID

NCT06253221
CV027-010
U1111-1290-1175
2023-505650-17-00
  • Ages 12-17
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of HCM

  • Presence of LVOT obstruction

  • Presence of symptoms

Exclusion

Exclusion Criteria:

  • Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomeredysfunction

  • Evidence of LVEF <50% in prior 6 months

  • Planned escalation in HCM therapy or upcoming intervention (eg, major cardiacsurgery, HCM medication dose increase)

Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 17, 2024
Estimated Completion Date:
March 28, 2031

Connect with a study center

  • Local Institution - 0020

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • Local Institution - 0020

    Sydney 2147714, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Local Institution - 0042

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Medical Centre Clayton

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Local Institution - 0028

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Local Institution - 0042

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Local Institution - 0041

    Edmonton, Alberta T6G 2R7
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2R7
    Canada

    Site Not Available

  • Local Institution - 0041

    Edmonton 5946768, Alberta 5883102 T6G 2R7
    Canada

    Site Not Available

  • Local Institution - 0046

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • The Hospital for Sick Children (SickKids)

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Local Institution - 0046

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • Hôpital Necker - Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Local Institution - 0022

    Paris, 75015
    France

    Site Not Available

  • Local Institution - 0022

    Paris 2988507, 75015
    France

    Site Not Available

  • CHU Hopitaux de Bordeaux - Hopital Haut-Leveque

    Pessac, 33604
    France

    Site Not Available

  • Local Institution - 0026

    Pessac, 33604
    France

    Site Not Available

  • Local Institution - 0026

    Pessac 2987805, 33604
    France

    Site Not Available

  • Charite - UB - CVK - Medizinische Klinik

    Berlin, BE 13353
    Germany

    Site Not Available

  • Local Institution - 0018

    Berlin, BE 13353
    Germany

    Site Not Available

  • Herzzentrum München

    Munich, BY 80636
    Germany

    Site Not Available

  • Local Institution - 0006

    Munich, BY 80636
    Germany

    Site Not Available

  • Local Institution - 0006

    Munich 2867714, Bavaria 2951839 80636
    Germany

    Site Not Available

  • Local Institution - 0018

    Berlin 2950159, State of Berlin 2950157 13353
    Germany

    Site Not Available

  • Local Institution - 0047

    Drimnagh, D D12 V443
    Ireland

    Site Not Available

  • Children's Health Ireland

    Dublin 12, D12 N512, D12 N512
    Ireland

    Site Not Available

  • Local Institution - 0047

    Dublin 12, D12 N512, D12 N512
    Ireland

    Site Not Available

  • Local Institution - 0047

    Dublin 12, D12 N512 2964574, D12 N512
    Ireland

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer

    Firenze, FI 50100
    Italy

    Site Not Available

  • Local Institution - 0016

    Firenze, FI 50100
    Italy

    Site Not Available

  • Local Institution - 0016

    Florence 3176959, FI 50100
    Italy

    Site Not Available

  • Istituto Giannina Gaslini

    Genova, GE 16147
    Italy

    Site Not Available

  • Local Institution - 0051

    Genova, GE 16147
    Italy

    Site Not Available

  • Local Institution - 0051

    Genova 8969657, GE 16147
    Italy

    Site Not Available

  • AORN - Ospedali dei Colli Ospedale V. Monaldi

    Napoli, 80131
    Italy

    Site Not Available

  • Local Institution - 0027

    Napoli, 80131
    Italy

    Site Not Available

  • Local Institution - 0027

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Hospital Sant Joan de Déu Barcelona

    Barcelona, B 8950
    Spain

    Site Not Available

  • Local Institution - 0014

    Barcelona, B 8950
    Spain

    Site Not Available

  • Local Institution - 0014

    Barcelona 3128760, B 8950
    Spain

    Site Not Available

  • Local Institution - 0021

    Granada, GR 18014
    Spain

    Site Not Available

  • Local Institution - 0048

    Madrid, M 28007
    Spain

    Site Not Available

  • Local Institution - 0011

    A Coruna, 15009
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Local Institution - 0023

    Madrid, 28041
    Spain

    Site Not Available

  • Local Institution - 0025

    Madrid, 28046
    Spain

    Site Not Available

  • Local Institution - 0025

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Local Institution - 0049

    Belfast, BFS BT12 6BA
    United Kingdom

    Site Not Available

  • Royal Belfast Hospital for Sick Children

    Belfast, BFS BT12 6BA
    United Kingdom

    Site Not Available

  • Local Institution - 0049

    Belfast 2655984, BFS BT12 6BA
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital

    London, WC1N 3JH
    United Kingdom

    Site Not Available

  • Local Institution - 0007

    London, WC1N 3JH
    United Kingdom

    Site Not Available

  • Local Institution - 0007

    London 2643743, WC1N 3JH
    United Kingdom

    Site Not Available

  • Local Institution - 0017

    Birmingham, Alabama 35294-0004
    United States

    Site Not Available

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35294-0004
    United States

    Active - Recruiting

  • Local Institution - 0017

    Birmingham 4049979, Alabama 4829764 35294-0004
    United States

    Site Not Available

  • Local Institution - 0050

    Phoenix, Arizona 85016-7710
    United States

    Site Not Available

  • Phoenix Children's Cardiology

    Phoenix, Arizona 85016-7710
    United States

    Site Not Available

  • Local Institution - 0050

    Phoenix 5308655, Arizona 5551752 85016-7710
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027-6062
    United States

    Site Not Available

  • Local Institution - 0008

    Los Angeles, California 90095-8344
    United States

    Site Not Available

  • Local Institution - 0032

    Los Angeles, California 90027-6062
    United States

    Site Not Available

  • University of California Los Angeles (UCLA) - Mattel Children's Hospital

    Los Angeles, California 90095-8344
    United States

    Active - Recruiting

  • Local Institution - 0004

    Oakland, California 94609
    United States

    Site Not Available

  • Local Institution - 0033

    Palo Alto, California 94304-1601
    United States

    Site Not Available

  • Lucile Packard Children's Hospital (LPCH)

    Palo Alto, California 94304-1601
    United States

    Site Not Available

  • Local Institution - 0044

    San Diego, California 92123-4223
    United States

    Site Not Available

  • Rady Children's Hospital-San Diego

    San Diego, California 92123-4223
    United States

    Site Not Available

  • Local Institution - 0008

    Los Angeles 5368361, California 5332921 90095-8344
    United States

    Site Not Available

  • Local Institution - 0032

    Los Angeles 5368361, California 5332921 90027-6062
    United States

    Site Not Available

  • Local Institution - 0033

    Palo Alto 5380748, California 5332921 94304-1601
    United States

    Site Not Available

  • Local Institution - 0044

    San Diego 5391811, California 5332921 92123-4223
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045-7106
    United States

    Site Not Available

  • Local Institution - 0038

    Aurora, Colorado 80045-7106
    United States

    Site Not Available

  • Local Institution - 0038

    Aurora 5412347, Colorado 5417618 80045-7106
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital

    Saint Petersburg, Florida 33701-4634
    United States

    Site Not Available

  • Local Institution - 0031

    Saint Petersburg, Florida 33701-4634
    United States

    Site Not Available

  • Local Institution - 0031

    St. Petersburg 4171563, Florida 4155751 33701-4634
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital

    Atlanta, Georgia 30329-3117
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta Foundation, Inc.

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Local Institution - 0053

    Atlanta, Georgia 30329-3117
    United States

    Site Not Available

  • Local Institution - 0053

    Atlanta 4180439, Georgia 4197000 30329-3117
    United States

    Site Not Available

  • Local Institution - 0013

    Chicago, Illinois 60637-1447
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago, Illinois 60637-1447
    United States

    Site Not Available

  • Local Institution - 0013

    Chicago 4887398, Illinois 4896861 60637-1447
    United States

    Site Not Available

  • Local Institution - 0009

    Indianapolis, Indiana 46202-5272
    United States

    Site Not Available

  • Riley Hospital for Children - Pediatric Cardiology

    Indianapolis, Indiana 46202-5272
    United States

    Site Not Available

  • Local Institution - 0009

    Indianapolis 4259418, Indiana 4921868 46202-5272
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115-5724
    United States

    Site Not Available

  • Local Institution - 0043

    Boston, Massachusetts 02115-5724
    United States

    Site Not Available

  • Local Institution - 0043

    Boston 4930956, Massachusetts 6254926 02115-5724
    United States

    Site Not Available

  • Local Institution - 0002

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan - C.S. Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Local Institution - 0002

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Local Institution - 0037

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis - St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Local Institution - 0037

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Atlantic Medical Group Hypertrophic Cardiomyopathy Associates

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Local Institution - 0052

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Local Institution - 0052

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Site Not Available

  • Local Institution - 0040

    Bronx, New York 10467-2403
    United States

    Site Not Available

  • The Children's Hospital at Montefiore

    Bronx, New York 10467-2403
    United States

    Site Not Available

  • Cohen Children's Medical Center of New York

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Local Institution - 0010

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029-6574
    United States

    Active - Recruiting

  • Local Institution - 0024

    New York, New York 10029-6574
    United States

    Site Not Available

  • Local Institution - 0036

    New York, New York 10032-1559
    United States

    Site Not Available

  • Morgan Stanley Children's Hospital of NewYork-Presbyterian

    New York, New York 10032-1559
    United States

    Site Not Available

  • Local Institution - 0010

    New Hyde Park 5128514, New York 5128638 11042
    United States

    Site Not Available

  • Local Institution - 0024

    New York 5128581, New York 5128638 10029-6574
    United States

    Site Not Available

  • Local Institution - 0036

    New York 5128581, New York 5128638 10032-1559
    United States

    Site Not Available

  • Local Institution - 0040

    The Bronx 5110266, New York 5128638 10467-2403
    United States

    Site Not Available

  • Local Institution - 0015

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Sanger Heart & Vascular Institute Heart Failure & Transplant Kenilworth

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Duke University Hospital

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Local Institution - 0039

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Local Institution - 0015

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Local Institution - 0039

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Local Institution - 0019

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • Local Institution - 0001

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • Local Institution - 0029

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Local Institution - 0019

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Local Institution - 0001

    Cleveland 5150529, Ohio 5165418 44195-0001
    United States

    Site Not Available

  • Local Institution - 0029

    Columbus 4509177, Ohio 5165418 43205
    United States

    Site Not Available

  • Children's Hospital of Philadelphia-Center for Childhood Cancer Research

    Philadelphia, Pennsylvania 19104-4319
    United States

    Site Not Available

  • Local Institution - 0030

    Philadelphia, Pennsylvania 19104-4319
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia (CHOP) - Lipid Heart Clinic - Main Campus

    Philadelphia, Pennsylvania 19104-4319
    United States

    Active - Recruiting

  • Local Institution - 0005

    Pittsburgh, Pennsylvania 15224-1334
    United States

    Site Not Available

  • UPMC Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224-1334
    United States

    Site Not Available

  • Local Institution - 0030

    Philadelphia 4560349, Pennsylvania 6254927 19104-4319
    United States

    Site Not Available

  • Local Institution - 0005

    Pittsburgh 5206379, Pennsylvania 6254927 15224-1334
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • Local Institution - 0034

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Local Institution - 0034

    Memphis 4641239, Tennessee 4662168 38105
    United States

    Site Not Available

  • Dell Children's Medical Center of Central Texas

    Austin, Texas 78712
    United States

    Site Not Available

  • Local Institution - 0045

    Austin, Texas 78712
    United States

    Site Not Available

  • Local Institution - 0055

    Dallas, Texas 75235
    United States

    Site Not Available

  • Local Institution - 0054

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0045

    Austin 4671654, Texas 4736286 78712
    United States

    Site Not Available

  • Local Institution - 0054

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Local Institution - 0003

    Salt Lake City, Utah 84113-1103
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City, Utah 84113-1103
    United States

    Site Not Available

  • Local Institution - 0003

    Salt Lake City 5780993, Utah 5549030 84113-1103
    United States

    Site Not Available

  • Local Institution - 0012

    Charlottesville, Virginia 22908-0816
    United States

    Site Not Available

  • University Of Virginia School of Medicine

    Charlottesville, Virginia 22908-0816
    United States

    Site Not Available

  • Local Institution - 0012

    Charlottesville 4752031, Virginia 6254928 22908-0816
    United States

    Site Not Available

  • Local Institution - 0035

    Madison, Wisconsin 53792-0002
    United States

    Site Not Available

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