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Само по покана Фаза 2/3 NCT04848506

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

Фаза 2/3 – комбинирано изпитване
Заболявания: Symptomatic Hypertrophic Cardiomyopathy (HCM)

Спонсор: Cytokinetics

Налично на: БГ
Обобщение
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Кой може да участва
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.
Места на провеждане 17
Argentina (1)
Instituto Cardiovascular de Buenos Aires(ICBA)
Buenos Aires
Австралия (1)
Flinders Medical Centre, Cardiology Research
Bedford Park
Бразилия (1)
Instituto Dante Pazzanese de Cardiologia
São Paulo
Канада (1)
Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval
Québec , Quebec
Чехия (1)
Il. Interni klinika kardiologie a angiologie
Prague
Дания (1)
Department of Cardiology Aalborg University Hospital
Aalborg
Франция (1)
Hopital de la Timone Service de cardiologie
Marseille
Гърция (1)
Evangelismos General Hospital of Athens
Athens
Унгария (1)
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest
Iceland (1)
Landspitali University Hospital
Reykjavik
Израел (1)
The Barzilai University Medical Center
Ashkelon
Италия (1)
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Florence
Нидерландия (1)
Amsterdam UMC
Amsterdam
Полша (1)
Kardio Brynow S.C.
Katowice
Испания (1)
Complejo Hospitalario Universitario A Coruna
A Coruña
Великобритания (1)
Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
Birmingham
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Технически детайли
Статус
Само по покана
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
06.05.2021
Крайна дата
01.03.2028
Регистрационен номер
NCT04848506
Източник
anzctr
Запитване за медицински туризъм

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