Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation
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
1 other identifier
interventional
160
8 countries
32
Brief Summary
The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 atrial-fibrillation
Started Sep 2005
Shorter than P25 for phase_2 atrial-fibrillation
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 18, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedDecember 6, 2007
December 1, 2007
November 17, 2005
December 4, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients that have converted from AF within 90 minutes from start of infusion.
Secondary Outcomes (1)
The time to conversion of AF from start of the infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Esbjerg, Denmark
Research Site
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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Münster, Germany
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Budapest, Hungary
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Cegléd, Hungary
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Kecskemét, Hungary
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Szentes, Hungary
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Székesfehérvár, 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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Tromsø, Norway
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Trondheim, Norway
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Bytom, Poland
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Opole, Poland
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Ruda Śląska, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Linköping, Sweden
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Örebro, Sweden
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Stockholm, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AZD7009 Midical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 18, 2005
Study Start
September 1, 2005
Study Completion
May 1, 2006
Last Updated
December 6, 2007
Record last verified: 2007-12