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NCT00255281 Clinical Trial

Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00255281
Other study ID # D1461C00006
Secondary ID
Status Completed
Phase Phase 2
First received November 17, 2005
Last updated December 4, 2007
Start date September 2005
Est. completion date May 2006

Study information
Verified date December 2007
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyHungary: National Institute of Pharmacy
Study type Interventional

Clinical Trial Summary

The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD7009, no generic name available

Locations
Country Name City State
Denmark Research Site Esbjerg
Denmark Research Site Hellerup
Denmark Research Site Hvidovre
Denmark Research Site Svendborg
Finland Research Site Helsinki
Finland Research Site Oulu
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
Hungary Research Site Budapest
Hungary Research Site Cegled
Hungary Research Site Kecskemet
Hungary Research Site Szekesfehervar
Hungary Research Site Szentes
Netherlands Research Site Groningen
Netherlands Research Site Maastricht
Netherlands Research Site Stadskanaal
Norway Research Site Oslo
Norway Research Site Rud
Norway Research Site Tromso
Norway Research Site Trondheim
Poland Research Site Bytom
Poland Research Site Opole
Poland Research Site Ruda Slaska
Poland Research Site Warszawa
Poland Research Site Wroclaw
Sweden Research Site Linkoping
Sweden Research Site Orebro
Sweden Research Site Stockholm

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Hungary,  Netherlands,  Norway,  Poland,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients that have converted from AF within 90 minutes from start of infusion.
Secondary The time to conversion of AF from start of the infusion.
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