Multi-Center, Placebo-Controlled, Phase 3 Study of Etripamil Nasal Spray (NS) in Patients With Atrial Fibrillation and Rapid Ventricular Rate (RVR)
Milestone Pharmaceuticals Inc.
Summary
This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit. Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study. Informed consent will be obtained prior to any study procedures.
Description
This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with AF. This study includes a Screening Visit, Randomization Visit, Treatment Period with Follow-up Visits (Monthly Follow-up Visits, and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow-up Visit. Each patient will be randomized in a 1:1 ratio to receive Placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR as follows: an initial dose of placeb…