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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03723655
Date of registration: 24/10/2018
Prospective Registration: Yes
Primary sponsor: MyoKardia, Inc.
Public title: A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
Scientific title: A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)
Date of first enrolment: October 5, 2018
Target sample size: 310
Recruitment status: Enrolling by invitation
URL:  https://clinicaltrials.gov/show/NCT03723655
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2/Phase 3
Countries of recruitment
Belgium Czechia Denmark France Germany Israel Italy Netherlands
Poland Portugal Spain United Kingdom United States
Contacts
Name:     Medical Information Team
Address: 
Telephone:
Email:
Affiliation:  MyoKardia, Inc.
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
Intervention(s)
Drug: mavacamten
Primary Outcome(s)
Frequency and severity of treatment-emergent adverse events and serious adverse events [Time Frame: 252 weeks]
Secondary Outcome(s)
Secondary ID(s)
MYK-461-007
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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