Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation - Tabular View

Tracking Information

First Received Date ^ICMJE

November 17, 2005

Last Updated Date

December 4, 2007

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00255281 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: AZD7009, no generic name available

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

160

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00255281

Responsible Party

Study ID Numbers ^ICMJE

D1461C00006

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca AZD7009 Midical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP