Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

This study has been completed.

First Received on November 17, 2005. Last Updated on December 4, 2007 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00255281

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 II

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:

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: AZD 7009

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255281

Locations

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 February 09, 2012