Efficacy and Safety of Etripamil for the Termination of Spontaneous PSVT. NODE 301 [Part 1 and Part 2 (The RAPID Study)]
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to
evaluate the efficacy and safety of etripamil NS self-administered by patients who experience
an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting.
Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of
150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301
study after the completion of Part 1.
The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not
dosed with the double-blind study drug, or had not discontinued the study before the
adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients
enrolled into the study following the completion of Part 1. Enrollment will continue until
and for approximately 6 months after the date of the adjudication of the 180th positively
adjudicated PSVT episode.
The study will include the following visits: A Screening Visit, A Test Dose Randomization
Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period
Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.