Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Launched by CYTOKINETICS · Apr 13, 2021
Trial Information
Current as of July 04, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Completion of a Cytokinetics trial investigating aficamten
- • LVEF ≥ 55% at the Screening Visit
- Exclusion Criteria:
- • Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
- • Has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
- * Since completion of a previous trial of aficamten has:
- • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days
- • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
- • Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
- • History of implantable ICD placement within 30 days prior to screening.
About Cytokinetics
Cytokinetics is a biopharmaceutical company dedicated to the discovery and development of innovative muscle-activating therapies to treat serious diseases and medical conditions characterized by muscle weakness and dysfunction. By leveraging its expertise in muscle biology and drug development, Cytokinetics aims to advance novel therapeutics for conditions such as heart failure, amyotrophic lateral sclerosis (ALS), and other neuromuscular disorders. The company is committed to scientific excellence and collaboration, working closely with academic institutions and industry partners to bring meaningful treatments to patients in need.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Charleston, South Carolina, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Portland, Oregon, United States
Paris, , France
Valhalla, New York, United States
Dallas, Texas, United States
Houston, Texas, United States
New York, New York, United States
Atlanta, Georgia, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Paris, , France
Washington, District Of Columbia, United States
Morristown, New Jersey, United States
Portland, Oregon, United States
Essen, , Germany
Salamanca, , Spain
Kansas City, Missouri, United States
Murray, Utah, United States
Fayetteville, Georgia, United States
San Francisco, California, United States
London, , United Kingdom
Sevilla, , Spain
London, , United Kingdom
Barcelona, , Spain
Pittsburgh, Pennsylvania, United States
Evanston, Illinois, United States
Sao Paulo, , Brazil
Burlington, Massachusetts, United States
Los Angeles, California, United States
Goettingen, , Germany
Jena, , Germany
Falls Church, Virginia, United States
Liverpool, , United Kingdom
New York, New York, United States
New Haven, Connecticut, United States
Lisboa, , Portugal
Houston, Texas, United States
Phoenix, Arizona, United States
London, , United Kingdom
New York, New York, United States
Quebec, , Canada
Ramat Gan, , Israel
Salt Lake City, Utah, United States
Ann Arbor, Michigan, United States
Los Angeles, California, United States
Durham, North Carolina, United States
Safed, , Israel
Anchorage, Alaska, United States
Berlin, , Germany
Sevilla, , Spain
New Haven, Connecticut, United States
Philadelphia, Pennsylvania, United States
Charlotte, North Carolina, United States
Firenze, , Italy
Madrid, , Spain
Nashville, Tennessee, United States
Madrid, , Spain
Fort Lauderdale, Florida, United States
Ashkelon, , Israel
Charlottesville, Virginia, United States
Budapest, , Hungary
Copenhagen, , Denmark
Pisa, , Italy
Jerusalem, , Israel
Coruña, , Spain
La Jolla, California, United States
Katowice, , Poland
Aarhus, , Denmark
Warszawa, , Poland
Glasgow, , United Kingdom
Copenhagen, , Denmark
Nantes, , France
Pessac, , France
Maastricht, , Netherlands
Oxford, , United Kingdom
Marseille, , France
Goettigen, , Germany
Rotterdam, , Netherlands
Ann Arbor, Michigan, United States
Würzburg, , Germany
Tulsa, Oklahoma, United States
Praha, , Czechia
Roma, , Italy
Aveiro, , Portugal
Birmingham, , United Kingdom
Pittsburg, Pennsylvania, United States
Palma, , Spain
Heidelberg, , Germany
Aalborg, , Denmark
Rennes, , France
Patients applied
Trial Officials
Cytokinetics, MD
Study Director
Cytokinetics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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