NCT05414175CompletedPhase 3
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safety and Tolerability of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 7 Jun 2022
- Start date
- 19 Aug 2022
- Primary completion date
- 27 Nov 2023
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT05414175
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 38
- From 19 Aug 2022 to the primary completion date, 27 Nov 2023
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
- History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
- Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
- Treatment (within 14 days prior to Screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine
- Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem
- Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study
- ICD placement within 2 months prior to Screening or planned ICD placement during the study
- Prior treatment with cardiotoxic agents such as doxorubicin or similar
- Other protocol-defined inclusion/exclusion criteria apply
Other illness
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
- Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion
Other
- Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening.
Who the study is looking for
- Age 18 and greater, body weight ≥ 35kg
- Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
- Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation Society guidelines
- Has documented left ventricular ejection fraction (LVEF) ≥60% NYHA Class II or III
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.