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Active, Not Recruiting

A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy - CV027-006

Aktualisiert: 17 Mai, 2023   |

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  • Phase 3


  • Geschlecht(er)

  • 18+


  • Active, Not Recruiting


Experimental: Drug: Mavacamten
Drug: Mavacamten
Placebo Comparator: Drug: Placebo
Drug: Placebo

Wichtigste Eignungskriterien

Key Inclusion Criteria: - At least 18 years old at screening and body weight > 45 kg at screening - Diagnosed with oHCM consistent with current ACCF/AHA 2011 and/or ESC 2014 guidelines and meet their recommendations for invasive therapies - Referred or under active consideration within the past 12 months for SRT procedure and willing to have SRT procedure - Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening - Has documented oxygen saturation at rest ≥ 90% at Screening Key Exclusion Criteria: - Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4 weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to screening - Previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) - For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications < 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study - Any medical condition that precludes upright exercise stress testing - Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening - Prior treatment with cardiotoxic agents, such as doxorubicin or similar - Has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion

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