Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation - Full Text View

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

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

Drug Information available for:

AZD 7009

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

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

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

Study placed in the following topic categories:

Heart Diseases

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 06, 2008

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