A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopa… (NCT03442764) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
United States59 participantsStarted 2018-03-30
Plain-language summary
This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Timeframe: From first dose to 8 weeks following last dose (Up to 24 weeks)
2
Percentage of Participants Who Experienced at Least One Serious Treatment-emergent Adverse Event (STEAE)
Timeframe: From first dose to 8 weeks following last dose (Up to 24 weeks)