A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acesion Pharma

Criteria

Key Inclusion Criteria:

• Clinical indication for cardioversion of AF

• Current episode of symptomatic AF lasting between 3-hour and 7 days (inclusive) at randomization

• Adequate anticoagulation according to international and/or national guidelines

Key Exclusion Criteria:

• Significant clinical illness or surgical procedure within 4 weeks preceding the screening visit

• History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator.

• Any cardioversion attempt of AF or atrial flutter within 4 weeks preceding randomization

• Use of any antiarrhythmic drug class I and/or III within 6 months before randomisation

Other protocol defined Inclusion/Exclusion criteria may apply