Hypertrophic Cardiomyopathy Clinical Trial
CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274)
The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)
Completion of a Cytokinetics trial investigating CK-3773274
LVEF ≥55% at the Screening Visit
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 25 Locations for this study
Los Angeles California, 90048, United States
San Francisco California, 94143, 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
Ann Arbor Michigan, 48109, United States
Kansas City Missouri, 64111, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22908, United States
Budapest , 1122, Hungary
Firenze , 50134, Italy
Katowice , 40-55, Poland
Warszawa , 04-62, Poland
Coruña , 15006, Spain
Madrid , 28220, Spain
Glasgow , G51 4, United Kingdom
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