Language: BG BG
← Back to results
By invitation only Phase 2/3 NCT04848506

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

Phase 2/3 – combined trial
Conditions: Symptomatic Hypertrophic Cardiomyopathy (HCM)

Sponsor: Cytokinetics

trial.available_in: БГ
Overview
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Who can participate
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.
Locations 17
Argentina (1)
Instituto Cardiovascular de Buenos Aires(ICBA)
Buenos Aires
Australia (1)
Flinders Medical Centre, Cardiology Research
Bedford Park
Brazil (1)
Instituto Dante Pazzanese de Cardiologia
São Paulo
Canada (1)
Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval
Québec , Quebec
Czech Republic (1)
Il. Interni klinika kardiologie a angiologie
Prague
Denmark (1)
Department of Cardiology Aalborg University Hospital
Aalborg
France (1)
Hopital de la Timone Service de cardiologie
Marseille
Greece (1)
Evangelismos General Hospital of Athens
Athens
Hungary (1)
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest
Iceland (1)
Landspitali University Hospital
Reykjavik
Israel (1)
The Barzilai University Medical Center
Ashkelon
Italy (1)
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Florence
Netherlands (1)
Amsterdam UMC
Amsterdam
Poland (1)
Kardio Brynow S.C.
Katowice
Spain (1)
Complejo Hospitalario Universitario A Coruna
A Coruña
United Kingdom (1)
Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
Birmingham
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
By invitation only
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
06.05.2021
Completion date
01.03.2028
Registry ID
NCT04848506
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.