Trial | NCT04571385  Report issue

Title

A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients With Atrial Fibrillation

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    AP30663 ...

  • Study Participants

    66
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.
Study Started
Sep 09
2019
Primary Completion
Dec 13
2022
Study Completion
Jan 23
2023
Last Update
Apr 26
2023

Drug AP30663

Administer by intravenous infusion.

Drug Placebo

Placebo matched to AP30663.

Part 1: AP30663 Experimental

Participants will receive single dose of AP30663.

Part 1: Placebo Placebo Comparator

Participants will receive placebo matched to AP30663.

Part 2: AP30663 Experimental

Participants will receive a single dose of one of the multiple dose levels of AP30663.

Part 2: Placebo Placebo Comparator

Participants will receive placebo matched to AP30663.

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
No Results Posted