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Etripamil NS

Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303

Ensayo de Milestone Pharmaceuticals Inc. en taquicardia supraventricular paroxistica.

Fase

Fase 3

Estado

Completado

Participantes

1.116

previstos

Centros

124

Fin del objetivo primario

ene 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2019.

Qué mide

Numero de participantes con acontecimientos adversos para etripamil NS autoadministrado fuera del entorno clinico. (From Baseline until a maximum of 4 episodes of perceived PSVT are treated with study drug, up to a maximum duration of 40 months.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroNODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT). Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when they felt the onset of PSVT symptoms. Participants self-administered etripamil NS if vagal maneuver was ineffective. After an episode of PSVT where study drug was administered, the participant returned to the investigative site and had the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes.

Más ensayos de MIST

Todos los de MIST, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04072835), actualizada en may 2024.