Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00255281

Enrollment

160

Registered

2005-11-18

Start date

2005-09-30

Completion date

2006-05-31

Last updated

2007-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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

Interventions

DRUGAZD7009, no generic name available

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The proportion of patients that have converted from AF within 90 minutes from start of infusion.	—

Secondary

Measure	Time frame
The time to conversion of AF from start of the infusion.	—

Countries

Denmark, Finland, Germany, Hungary, Netherlands, Norway, Poland, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026