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Cardiac Electrophysiological Study

NCT ID: NCT00616629

Last Updated: 2011-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures

Detailed Description

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Conditions

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Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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AZD1305

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with atrial flutter (with a ventricular rate of \<100 beats/minute at enrolment), scheduled for curative catheter ablation
* Sinus rhythm at randomisation

Exclusion Criteria

* QTc (Fridericia, QTcF ) \>450 ms measured in sinus rhythm at randomisation,
* Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
* QRS duration \>120 ms at randomisation
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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AstraZeneca

Principal Investigators

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Lauri Toivonen, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Research Site

Aalborg, , Denmark

Site Status

Research Site

Aarhus, , Denmark

Site Status

Research Site

Copenhagen, , Denmark

Site Status

Research Site

Hellerup, , Denmark

Site Status

Research Site

Helsinki, , Finland

Site Status

Research Site

Kuopio, , Finland

Site Status

Research Site

Oulu, , Finland

Site Status

Research Site

Bergen, , Norway

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Gŏteborg, , Sweden

Site Status

Research Site

Linkŏping, , Sweden

Site Status

Research Site

Ŏrebro, , Sweden

Site Status

Research Site

Umeå, , Sweden

Site Status

Countries

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Denmark Finland Norway Sweden

Other Identifiers

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2007-0003455-36 (EudraCT No)

Identifier Type: -

Identifier Source: secondary_id

D3190C00005

Identifier Type: -

Identifier Source: org_study_id