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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03723655
Other study ID # CV027-003
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 5, 2018
Est. completion date March 15, 2030

Study information

Verified date March 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 282
Est. completion date March 15, 2030
Est. primary completion date March 15, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included in this study pending MyoKardia Medical Monitoring approval) Participants who prematurely discontinued from the Parent Study or the MAVA-LTE study may be considered for inclusion. - Has a body weight greater than 45 kg at the Screening Visit - Has adequate acoustic windows to enable accurate TTEs. - Has documented LVEF = 50% by echocardiography core laboratory read of screening TTE at rest. - Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range). - Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP). 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: - Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II). - Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit. - Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the study. - Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study. - History of clinically significant malignant disease that developed since enrollment in the Parent Study. - Is unable to comply with the study requirements, including the number of required visits to the clinical site. - Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
mavacamten
mavacamten capsules

Locations

Country Name City State
Belgium Local Institution - 0002 Aalst
Belgium Local Institution - 0001 Brussels
Belgium Local Institution - 0003 Edegem
Czechia Local Institution - 0009 Prague
Czechia Local Institution - 0010 Praha 2
Denmark Local Institution - 0011 Aarhus
Denmark Local Institution - 0012 Frederiksberg
Denmark Local Institution - 0013 Odense
France Local Institution - 0014 Nantes
France Local Institution - 0016 Paris
France Local Institution - 0017 Paris
France Local Institution - 0015 Toulouse
Germany Local Institution - 0020 Bad Nauheim
Germany Local Institution - 0018 Dresden
Germany Local Institution - 0019 Goettingen
Germany Local Institution - 0021 Heidelberg
Israel Local Institution - 0027 Jerusalem
Israel Local Institution - 0024 Petah Tikva
Israel Local Institution - 0022 Ramat-gan
Israel Local Institution - 0025 Rehovot
Israel Local Institution - 0023 Safed
Israel Local Institution - 0026 Tel Aviv
Italy Local Institution - 0028 Firenze
Netherlands Local Institution - 0029 Maastricht
Netherlands Local Institution - 0030 Rotterdam
Poland Local Institution - 0033 Katowice
Poland Local Institution - 0034 Krakow
Poland Local Institution - 0031 Poznan
Poland Local Institution - 0032 Warsaw
Portugal Local Institution - 0036 Almada
Portugal Local Institution - 0035 Lisboa
Spain Local Institution - 0038 A Coruña
Spain Local Institution - 0037 El Palmar
Spain Local Institution - 0040 Madrid
Spain Local Institution - 0039 Majadahonda
Spain Local Institution - 0041 Sevilla
United Kingdom Local Institution - 0042 London
United States Local Institution - 0051 Ann Arbor Michigan
United States Local Institution - 0068 Bethlehem Pennsylvania
United States Local Institution - 0054 Boston Massachusetts
United States Local Institution - 0071 Charlotte North Carolina
United States Local Institution - 0053 Charlottesville Virginia
United States Local Institution - 0050 Chicago Illinois
United States Local Institution - 0052 Cincinnati Ohio
United States Local Institution - 0061 Dallas Texas
United States Local Institution - 0047 Durham North Carolina
United States Local Institution - 0074 Grand Rapids Michigan
United States Local Institution - 0055 Houston Texas
United States Local Institution - 0057 Houston Texas
United States Local Institution - 0070 Indianapolis Indiana
United States Local Institution - 0049 Iowa City Iowa
United States Local Institution - 0067 Jacksonville Florida
United States Local Institution - 0058 Los Angeles California
United States Local Institution - 0073 Memphis Tennessee
United States Local Institution - 0072 Murray Utah
United States Local Institution - 0043 New Haven Connecticut
United States Local Institution - 0056 New York New York
United States Local Institution - 0060 New York New York
United States Local Institution - 0046 Philadelphia Pennsylvania
United States Local Institution - 0064 Pittsburgh Pennsylvania
United States Local Institution - 0044 Portland Oregon
United States Local Institution - 0059 Richmond Virginia
United States Local Institution - 0048 Saint Louis Missouri
United States Local Institution - 0062 Salt Lake City Utah
United States Local Institution - 0066 San Francisco California
United States Local Institution - 0045 Scottsdale Arizona
United States Local Institution - 0065 Seattle Washington
United States Local Institution - 0063 Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Denmark,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency and severity of treatment-emergent adverse events and serious adverse events 252 weeks
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