Calendario›MIST›Etripamil · NODE-301
Etripamil · NODE-301
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
Ensayo de Milestone Pharmaceuticals Inc. en Taquicardia supraventricular paroxistica.
Lo que ha anunciado la empresa
La empresa anunció que alcanzó su objetivo principal…royalties of up to 18% on future sales of etripamil in Greater China. The NMPA approval was based on data from the global pivotal Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China. JX02002 met its primary endpoint, demonstrating that etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment (hazard ratio = 3.002 [95% CI: 1.578, 5.711]; p = 0.0005). Overall…
En un 8-K del 3 sep 2026, en una frase que nombra «Etripamil». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principal…In clinical studies, participants using etripamil were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered etripamil (N=99) converting from PSVT to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR=2.62; p<0.001). At one hour, the benefit was demonstrated…
En un 8-K del 6 ene 2026, en una frase que nombra «Etripamil». El documento en la SEC.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 1.097
- Centros
- 161
- Fin del objetivo primario
- ene 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2018.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The closure of the event-driven study was terminated due to the total sample size was reached.».
Qué mide
El tiempo para la conversion de un episodio de PSVT a ritmo sinusal (SR) tras la administracion del farmacos del estudio. (NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing.) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting. NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).
Más ensayos de MIST
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Etripamil NS | Fase 2 | Reclutando pacientes | jun 2027 (prevista) |
| Etripamil · ReVeRA-301 | Fase 3 | Reclutando pacientes | dic 2028 (prevista) |
| Etripamil NS 70 mg | Fase 3 | Completado | abr 2026 (real) |
| Etripamil | Fase 2 | Completado | ago 2023 (real) |
| Etripamil NS | Fase 3 | Completado | ene 2023 (real) |
| Etripamil NS 70 mg | Fase 3 | Interrumpido | nov 2020 (real) |
Todos los de MIST, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03464019), actualizada en jun 2024.