Text Size

Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255281
First received: November 17, 2005
Last updated: December 4, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
 Drug: AZD7009, no generic name available
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment: 160
Study Start Date: September 2005
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255281

Locations
Denmark
Research Site
Esbjerg, Denmark
Research Site
Hellerup, Denmark
Research Site
Hvidovre, Denmark
Research Site
Svendborg, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Oulu, Finland
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, Germany
Hungary
Research Site
Budapest, Hungary
Research Site
Cegled, Hungary
Research Site
Kecskemet, Hungary
Research Site
Szekesfehervar, Hungary
Research Site
Szentes, Hungary
Netherlands
Research Site
Groningen, Netherlands
Research Site
Maastricht, Netherlands
Research Site
Stadskanaal, Netherlands
Norway
Research Site
Oslo, Norway
Research Site
Rud, Norway
Research Site
Tromso, Norway
Research Site
Trondheim, Norway
Poland
Research Site
Bytom, Poland
Research Site
Opole, Poland
Research Site
Ruda Slaska, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Sweden
Research Site
Linkoping, Sweden
Research Site
Orebro, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AZD7009 Midical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00255281     History of Changes
Other Study ID Numbers: D1461C00006
Study First Received: November 17, 2005
Last Updated: December 4, 2007
Health Authority: Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013