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Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

NCT ID: NCT00255281

Last Updated: 2007-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AZD7009, no generic name available

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca AZD7009 Midical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Esbjerg, , Denmark

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Hellerup, , Denmark

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Hvidovre, , Denmark

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Svendborg, , Denmark

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Helsinki, , Finland

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Oulu, , Finland

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Aachen, , Germany

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Bad Berka, , Germany

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Brandenburg, , Germany

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Hamburg, , Germany

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Magdeburg, , Germany

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Münster, , Germany

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Budapest, , Hungary

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Cegléd, , Hungary

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Kecskemét, , Hungary

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Szentes, , Hungary

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Székesfehérvár, , Hungary

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Groningen, , Netherlands

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Maastricht, , Netherlands

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Stadskanaal, , Netherlands

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Oslo, , Norway

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Rud, , Norway

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Tromsø, , Norway

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Trondheim, , Norway

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Bytom, , Poland

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Opole, , Poland

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Ruda Śląska, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Linköping, , Sweden

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Örebro, , Sweden

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Stockholm, , Sweden

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Countries

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Denmark Finland Germany Hungary Netherlands Norway Poland Sweden

Other Identifiers

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D1461C00006

Identifier Type: -

Identifier Source: org_study_id