Clinical trial NCT00255281: Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The proportion of patients that have converted from AF within 90 minutes from start of infusion.
Secondary outcomes:
measure: The time to conversion of AF from start of the infusion.
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Brandenburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szentes
country: Hungary
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Stadskanaal
country: Netherlands
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Rud
country: Norway
facility: Research Site
city: Tromso
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AZD7009 Midical Science Director, MD
role: STUDY_DIRECTOR
References: