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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.
 
ClinicalTrials.gov Identifier: NCT00255281
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
AstraZeneca

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

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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
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine





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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00255281


Locations
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Denmark
Research Site
Esbjerg, Denmark
Research Site
Hellerup, Denmark
Research Site
Hvidovre, Denmark
Research Site
Svendborg, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Oulu, Finland
Germany
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
Hungary
Research Site
Budapest, Hungary
Research Site
Cegled, Hungary
Research Site
Kecskemet, Hungary
Research Site
Szekesfehervar, Hungary
Research Site
Szentes, Hungary
Netherlands
Research Site
Groningen, Netherlands
Research Site
Maastricht, Netherlands
Research Site
Stadskanaal, Netherlands
Norway
Research Site
Oslo, Norway
Research Site
Rud, Norway
Research Site
Tromso, Norway
Research Site
Trondheim, Norway
Poland
Research Site
Bytom, Poland
Research Site
Opole, Poland
Research Site
Ruda Slaska, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Sweden
Research Site
Linkoping, Sweden
Research Site
Orebro, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AZD7009 Midical Science Director, MD AstraZeneca
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ClinicalTrials.gov Identifier: NCT00255281    
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:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes