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Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD7009, no generic name available
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

The proportion of patients that have converted from AF within 90 minutes from start of infusion.

Secondary Outcome Measures

The time to conversion of AF from start of the infusion.

Full Information

First Posted
November 17, 2005
Last Updated
December 4, 2007
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00255281
Brief Title
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

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AZD7009, no generic name available
Primary Outcome Measure Information:
Title
The proportion of patients that have converted from AF within 90 minutes from start of infusion.
Secondary Outcome Measure Information:
Title
The time to conversion of AF from start of the infusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AZD7009 Midical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Esbjerg
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
Svendborg
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Oulu
Country
Finland
Facility Name
Research Site
City
Aachen
Country
Germany
Facility Name
Research Site
City
Bad Berka
Country
Germany
Facility Name
Research Site
City
Brandenburg
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Magdeburg
Country
Germany
Facility Name
Research Site
City
Munster
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Cegled
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
Country
Hungary
Facility Name
Research Site
City
Szentes
Country
Hungary
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Maastricht
Country
Netherlands
Facility Name
Research Site
City
Stadskanaal
Country
Netherlands
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Rud
Country
Norway
Facility Name
Research Site
City
Tromso
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Bytom
Country
Poland
Facility Name
Research Site
City
Opole
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Orebro
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

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