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A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients

NCT ID: NCT01396226

Last Updated: 2012-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-01-31

Brief Summary

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Medical Products Agency

Detailed Description

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* A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure.
* The study has an adaptive design. In the 1st dose group the planned number of randomised patients is 24. The tentative number of randomised patients in the optional 2nd dose group is 12, 24 or 36 and thus a total maximum of 60 patients will be randomised in the study.

Conditions

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Arrhythmia

Keywords

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Atrial refractoriness cardiac electrophysiology IKACh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

A single dose of AZD2927 administered as an iv infusion

Group Type EXPERIMENTAL

AZD2927

Intervention Type DRUG

A single dose of AZD2927 administered as an iv infusion

2

A single dose of placebo administered as an iv infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A single dose of placebo administered as an iv infusion

Interventions

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AZD2927

A single dose of AZD2927 administered as an iv infusion

Intervention Type DRUG

Placebo

A single dose of placebo administered as an iv infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or postmenopausal female, aged 20 to 80 years inclusive,
* clinical indication for catheter ablation of atrial flutter,
* history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
* sinus rhythm at randomisation,
* adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,

Exclusion Criteria

* cardioversion within 14 days before randomisation,
* history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
* QTcF \>450 ms or \<350 ms measured in sinus rhythm at randomisation,
* history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
* personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (\>30 s) monomorphic ventricular tachycardia.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan C Carlsson, MD, PHD

Role: STUDY_DIRECTOR

AstraZeneca

Hakan Walfridsson, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Linkoping Sweden

Locations

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Research Site

Oslo, , Norway

Site Status

Research Site

Linköping, , Sweden

Site Status

Research Site

Örebro, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Umeå, , Sweden

Site Status

Countries

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Norway Sweden

Other Identifiers

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2011-001716-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D4120C00002

Identifier Type: -

Identifier Source: org_study_id