Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255281
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : December 6, 2007
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Brief Summary:
The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: AZD7009, no generic name available Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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
Study Start Date : September 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255281

Research Site
Esbjerg, Denmark
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Hellerup, Denmark
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Hvidovre, Denmark
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Svendborg, Denmark
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Helsinki, Finland
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Oulu, Finland
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Aachen, Germany
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Bad Berka, Germany
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Brandenburg, Germany
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Hamburg, Germany
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Magdeburg, Germany
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Munster, Germany
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Budapest, Hungary
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Cegled, Hungary
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Kecskemet, Hungary
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Szekesfehervar, Hungary
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Szentes, Hungary
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Groningen, Netherlands
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Maastricht, Netherlands
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Stadskanaal, Netherlands
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Oslo, Norway
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Rud, Norway
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Tromso, Norway
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Trondheim, Norway
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Bytom, Poland
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Opole, Poland
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Ruda Slaska, Poland
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Warszawa, Poland
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Wroclaw, Poland
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Linkoping, Sweden
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Orebro, Sweden
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Stockholm, Sweden
Sponsors and Collaborators
Study Director: AstraZeneca AZD7009 Midical Science Director, MD AstraZeneca Identifier: NCT00255281     History of Changes
Other Study ID Numbers: D1461C00006
First Posted: November 18, 2005    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes