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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:  NCT03442764
Date of registration: 09/02/2018
Prospective Registration: Yes
Primary sponsor: MyoKardia, Inc.
Public title: A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) MAVERICK-HCM
Scientific title: A Randomized, Double-blind, Placebo-controlled, Concentration-guided, Exploratory Study of Mavacameten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) and Preserved Left Ventricular Ejection Fraction
Date of first enrolment: March 30, 2018
Target sample size: 59
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03442764
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Myokardia Medical Information Team
Address: 
Telephone:
Email:
Affiliation:  MyoKardia, Inc.
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Diagnosed with nHCM (hypertrophied and non-dilated left ventricle in absence of
systemic or other known cause), with LV wall thickness = 15mm at Screening or = 13mm
with a positive family history of HCM.

- Age 18 and greater, Body weight = 45kg

- Documented LVEF = 55% at the Screening as determined by echo central lab

- LVOT gradient < 30 mmHg at rest AND during Valsalva AND post-exercise

- NYHA functional class II or III

- Elevated NT-proBNP at rest

Key Exclusion Criteria:

- History of syncope, sustained ventricular tachyarrhythmia with exercise, obstructive
coronary artery disease or myocardial infarction within the past 6 months

- History of resuscitated sudden cardiac arrest at any time or known appropriate
implantable cardioverter defibrillator (ICD) discharge within 6 months prior to
Screening

- Current treatment with disopyramide or ranolazine (within 14 days prior to Screening)

- Current or planned treatment during the study with a combination of beta-blockers and
calcium channel blockers

- Has been treated with invasive septal reduction (surgical myectomy or percutaneous
alcohol septal ablation [ASA]) within 6 months prior to Screening

- History of resting or post-exercise LVOT >30 mmHg unless subsequently treated by
septal reduction

- Has QTc Fridericia (QTcF) >480 ms or any other ECG abnormality considered by the
investigator to pose a risk to participant safety (eg, second-degree atrioventricular
block type II)

- Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4
weeks prior to Screening and/or not adequately rate-controlled within 1 year of
Screening

- History of clinically significant malignant disease within 10 years such as
non-metastatic cutaneous squamous cell or basal cell carcinoma

- History or evidence of any other clinically significant disorder, condition, or
disease that, in the opinion of the investigator or MyoKardia physician, would pose a
risk to subject safety or interfere with the study evaluation, procedures, or
completion.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Non-obstructive Hypertrophic Cardiomyopathy
Intervention(s)
Drug: mavacamten
Drug: Placebo
Primary Outcome(s)
Frequency and severity of treatment-emergent adverse events and serious adverse events. [Time Frame: 16 Weeks]
Secondary Outcome(s)
Secondary ID(s)
MYK-461-006
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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