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OpenTrials
Completed

NCT Number: NCT00255281

Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Esbjerg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical indication for cardioversion of Atrial Fibrillation. Effective oral anticoagulation according to local routines or a TEE without any finding of intracardial thrombus or signs of thrombogenecity

Exclusion criteria

  • Clinically significant sinus and/or AV node dysfunction. Serum or plasma potassium <3.8 mmol/L or >5.0 mmol/L. QTc(Bazett) >450 ms. Any QRS duration >150 ms

Treatment and study plan

AZD7009, no generic name available

Drug

Primary outcomes

  1. The proportion of patients that have converted from AF within 90 minutes from start of infusion.

Secondary outcomes

  1. The time to conversion of AF from start of the infusion.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase II Study to Assess the Efficacy of AZD7009 (AR H065522XX) Given Intravenously (Infusion for 15 or 30 Minutes) to Patients for Conversion of Atrial Fibrillation

Important dates

Study start
2005
Study completion
2006
First posted
Nov 18, 2005
Registry last updated
Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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