ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2

Summary

Participation Requirements

Description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil Nasal Spray in patients with atrial fibrillation (AF). This study includes Screening, the Treatment Period and Follow-up procedures. Each subject will receive placebo or 70 mg of etripamil...

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil Nasal Spray in patients with atrial fibrillation (AF). This study includes Screening, the Treatment Period and Follow-up procedures. Each subject will receive placebo or 70 mg of etripamil intranasally; treatment will be randomized in a 1:1 ratio, to yield 50 evaluable patients with atrial fibrillation in 2 groups of 25. Patients with atrial fibrillation (AF) will be selected by the Investigator. The screening procedures will include a review of inclusion/exclusion criteria and recording of any concomitant medications. After screening procedures are complete, eligible patients will be randomized to receive etripamil or placebo. Heart rate will be measured via Holter ECG (Electrocardiogram)10 minutes prior to and immediately before drug administration; patients must exhibit a rapid ventricular rate (?110 bpm measured during 1 minute) prior to drug administration in order to be dosed. Blinded study drug will be administered during Holter ECG (Electrocardiogram) monitoring, which will be conducted for at least 10 minutes prior to and for 6 hours after administration. Patients will undergo a safety follow-up assessment and return the Holter device approximately 24 hours post-dose. Patients will also be contacted by phone 7 days post-dosing for safety follow-up.

Tracking Information