Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

December 4, 2007 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark
        • Research Site
      • Hellerup, Denmark
        • Research Site
      • Hvidovre, Denmark
        • Research Site
      • Svendborg, Denmark
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
  • Germany
      • Aachen, Germany
        • Research Site
      • Bad Berka, Germany
        • Research Site
      • Brandenburg, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Munster, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Cegled, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
      • Szentes, Hungary
        • Research Site
  • Netherlands
      • Groningen, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Stadskanaal, Netherlands
        • Research Site
  • Norway
      • Oslo, Norway
        • Research Site
      • Rud, Norway
        • Research Site
      • Tromso, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Poland
      • Bytom, Poland
        • Research Site
      • Opole, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Orebro, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca AZD7009 Midical Science Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 18, 2005

Study Record Updates

Last Update Posted (Estimate)

December 6, 2007

Last Update Submitted That Met QC Criteria

December 4, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1461C00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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