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Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 17, 2005
Last updated: December 4, 2007
Last verified: December 2007
The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF

Condition Intervention Phase
Atrial Fibrillation Drug: AZD7009, no generic name available Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of patients that have converted from AF within 90 minutes from start of infusion.

Secondary Outcome Measures:
  • The time to conversion of AF from start of the infusion.

Estimated Enrollment: 160
Study Start Date: September 2005
Study Completion Date: May 2006

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00255281

Research Site
Esbjerg, Denmark
Research Site
Hellerup, Denmark
Research Site
Hvidovre, Denmark
Research Site
Svendborg, Denmark
Research Site
Helsinki, Finland
Research Site
Oulu, Finland
Research Site
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
Budapest, Hungary
Research Site
Cegled, Hungary
Research Site
Kecskemet, Hungary
Research Site
Szekesfehervar, Hungary
Research Site
Szentes, Hungary
Research Site
Groningen, Netherlands
Research Site
Maastricht, Netherlands
Research Site
Stadskanaal, Netherlands
Research Site
Oslo, Norway
Research Site
Rud, Norway
Research Site
Tromso, Norway
Research Site
Trondheim, Norway
Research Site
Bytom, Poland
Research Site
Opole, Poland
Research Site
Ruda Slaska, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Research Site
Linkoping, Sweden
Research Site
Orebro, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
Study Director: AstraZeneca AZD7009 Midical Science Director, MD AstraZeneca
  More Information Identifier: NCT00255281     History of Changes
Other Study ID Numbers: D1461C00006
Study First Received: November 17, 2005
Last Updated: December 4, 2007

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on August 18, 2017