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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00255281 |
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Date of registration:
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17/11/2005 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation
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Scientific title:
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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 |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00255281 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Finland
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Germany
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Hungary
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Netherlands
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Norway
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Poland
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Sweden
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Contacts
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Name:
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AstraZeneca AZD7009 Midical Science Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Drug: AZD7009, no generic name available
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Primary Outcome(s)
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The proportion of patients that have converted from AF within 90 minutes from start of infusion.
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Secondary Outcome(s)
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The time to conversion of AF from start of the infusion.
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Secondary ID(s)
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D1461C00006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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