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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06253221
Other study ID # CV027-010
Secondary ID 2023-505650-17-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 17, 2024
Est. completion date March 29, 2030

Study information

Verified date June 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 29, 2030
Est. primary completion date February 15, 2028
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: - Diagnosis of HCM - Presence of LVOT obstruction - Presence of symptoms Exclusion Criteria: - Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction - Evidence of LVEF <50% in prior 6 months - Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase) Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design


Intervention

Drug:
Mavacamten
Specified dose on specified days
Placebo
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0042 Clayton Victoria
Australia Local Institution - 0028 Parkville Victoria
Australia Local Institution - 0020 Sydney New South Wales
Canada Local Institution - 0041 Edmonton Alberta
Canada Local Institution - 0046 Toronto Ontario
France Local Institution - 0022 Paris
France Local Institution - 0026 Pessac
Germany Local Institution - 0018 Berlin BE
Germany Local Institution - 0006 Munich BY
Ireland Local Institution - 0047 Drimnagh D
Italy Local Institution - 0016 Firenze FI
Italy Local Institution - 0051 Genova GE
Italy Local Institution - 0027 Napoli
Spain Local Institution - 0011 A Coruna
Spain Local Institution - 0014 Barcelona B
Spain Local Institution - 0021 Granada GR
Spain Local Institution - 0023 Madrid
Spain Local Institution - 0025 Madrid
Spain Local Institution - 0048 Madrid M
United Kingdom Local Institution - 0049 Belfast BFS
United Kingdom Local Institution - 0007 London
United States University of Michigan - C.S. Mott Children's Hospital Ann Arbor Michigan
United States Children's Healthcare of Atlanta Foundation, Inc. Atlanta Georgia
United States Local Institution - 0038 Aurora Colorado
United States Local Institution - 0045 Austin Texas
United States Local Institution - 0017 Birmingham Alabama
United States Local Institution - 0043 Boston Massachusetts
United States Local Institution - 0040 Bronx New York
United States Local Institution - 0015 Charlotte North Carolina
United States University Of Virginia School of Medicine Charlottesville Virginia
United States Local Institution - 0013 Chicago Illinois
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 - 0055 Dallas Texas
United States Local Institution - 0039 Durham North Carolina
United States Local Institution - 0054 Houston Texas
United States Riley Hospital for Children - Pediatric Cardiology Indianapolis Indiana
United States Local Institution - 0008 Los Angeles California
United States Local Institution - 0032 Los Angeles California
United States Local Institution - 0035 Madison Wisconsin
United States Le Bonheur Children's Hospital Memphis Tennessee
United States Local Institution - 0052 Morristown New Jersey
United States Cohen Children's Medical Center of New York New Hyde Park New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States Local Institution - 0036 New York New York
United States Local Institution - 0004 Oakland California
United States Local Institution - 0033 Palo Alto California
United States The Children's Hospital of Philadelphia (CHOP) - Lipid Heart Clinic - Main Campus Philadelphia Pennsylvania
United States Phoenix Children's Cardiology Phoenix Arizona
United States UPMC Childrens Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Washington University School of Medicine in St. Louis - St. Louis Children's Hospital Saint Louis Missouri
United States Local Institution - 0031 Saint Petersburg Florida
United States Local Institution - 0003 Salt Lake City Utah
United States Local Institution - 0044 San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Ireland,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient At Week 28
Secondary Change from baseline in resting LVOT gradient At Week 28
Secondary Change from baseline in post-exercise peak LVOT gradient At Week 28
Secondary Change from baseline in maximal wall thickness At Week 28
Secondary Change from baseline in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e') At Week 28
Secondary Proportion of participants achieving an increase from baseline to Week 28 in peak oxygen uptake test (pVO2) From baseline up to Week 28
Secondary Proportion of participants achieving a reduction from baseline to Week 28 in maximal LVOT gradient to < 30 mmHg From baseline up to Week 28
Secondary Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) class from baseline to Week 28 From baseline up to Week 28
Secondary Proportion of participants with at least 1 grade improvement in mitral regurgitation at Week 28 From baseline up to Week 28
Secondary Number of participants with treatment-emergent adverse events (TEAEs) Up to Week 74
Secondary Number of participants with treatment-emergent serious adverse events (TESAEs) Up to Week 74
Secondary Change from baseline in electrocardiogram (ECG) (QT interval) At Week 28
Secondary Number of participants with left ventricular ejection fraction (LVEF) = 30% Up to Week 56
Secondary Number of participants with LVEF = 50% Up to Week 56
Secondary Trough observed plasma concentration (Ctrough) Up to Week 56
Secondary Post-dose plasma concentration of mavacamten Up to Week 56
Secondary Maximum observed concentration (Cmax) Up to Week 56
Secondary Area under the concentration-time curve (AUC) Up to Week 56
Secondary Proportion of participants who evaluate taste and swallowability as neutral or better using taste and swallowability scales At Day 1 and Week 11
Secondary Change from baseline in the Hypertrophic Cardiomyopathy Symptom Questionnaire - Shortness of Breath (HCMSQ SoB) domain At Week 28
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