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A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

RecruitingPhase 2Ages 18 Years - anyAllImbria Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Select Inclusion Criteria: * Has a clinical diagnosis of HCM consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definitions * Has had confirmation of nHCM by the echocardiography core laboratory based on screening rest and exercise stress echocardiography * New York Heart Association (NYHA) functional Class II or III at screening * Functional limitation as defined by a screening CPET Select Exclusion Criteria: * Has a known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nHCM * Has any other condition judged by the investigator to be the primary cause of dyspnea, exercise intolerance, and/or angina * Has an inability to exercise on a treadmill or bicycle (eg, orthopedic limitations) * Has any medical condition that precludes upright exercise stress testing Other protocol-defined inclusion and exclusion criteria apply.
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What it tests

  • Ninerafaxstat 200mg MR
  • Placebo
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Where

76 sites
Imbria Investigational Site
La Jolla, United States
Imbria Investigational Site
Los Angeles, United States
Imbria Investigational Site
San Francisco, United States
Imbria Investigational Site
Washington D.C., United States
Imbria Investigational Site
Miami, United States
Imbria Investigational Site
Atlanta, United States
Imbria Investigational Site
Chicago, United States
Imbria Investigational Site
Oak Lawn, United States

โ€ฆand 68 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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