Hypertrophic Cardiomyopathy Clinical Trial
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)
Eligibility Criteria
Inclusion Criteria:
Completion of a Cytokinetics trial investigating CK-3773274
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 CK-3773274 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) since the completion of a prior trial of CK-3773274.
Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274
History of appropriate ICD shock within 30 days prior to screening
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There are 64 Locations for this study
Anchorage Alaska, 99508, United States
La Jolla California, 92037, United States
Los Angeles California, 90048, United States
Los Angeles California, 90048, United States
San Francisco California, 94143, United States
New Haven Connecticut, 06519, United States
Washington District of Columbia, 20010, United States
Fort Lauderdale Florida, 33308, United States
Evanston Illinois, 60208, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Burlington Massachusetts, 01805, United States
Ann Arbor Michigan, 48109, United States
Ann Arbor Michigan, 48109, United States
Kansas City Missouri, 64111, United States
Morristown New Jersey, 07960, United States
New York New York, 10016, United States
New York New York, 10032, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Tulsa Oklahoma, 76104, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Praha , 128 0, Czechia
Aarhus , 8200, Denmark
Copenhagen , 2100, Denmark
Copenhagen , 2400, Denmark
Marseille , 13000, France
Nantes , 44093, France
Paris , 75010, France
Paris , 75015, France
Pessac , 33604, France
Goettigen , 37075, Germany
Würzburg , 97078, Germany
Budapest , 1122, Hungary
Ashkelon , 78306, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52656, Israel
Safed , 13110, Israel
Firenze , 50134, Italy
Pisa , 56124, Italy
Roma , 00189, Italy
Maastricht , 6229 , Netherlands
Rotterdam , 3015, Netherlands
Katowice , 40-55, Poland
Warszawa , 04-62, Poland
Aveiro , 3814-, Portugal
Coruña , 15006, Spain
Madrid , 28220, Spain
Madrid , 30120, Spain
Salamanca , 37007, Spain
Sevilla , 41009, Spain
Birmingham , B15 2, United Kingdom
Glasgow , G51 4, United Kingdom
Liverpool , L14 3, United Kingdom
London , EC1A , United Kingdom
London , SW17 , United Kingdom
London , SW3 6, United Kingdom
Oxford , OX3 9, United Kingdom
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