Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

NCT ID: NCT00915356

Last Updated: 2012-02-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-12-31

Brief Summary

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This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

AZD1305 iv infusion

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

2

Placebo iv infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

Interventions

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AZD1305

Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

Intervention Type DRUG

Placebo

iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
* Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
* Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines

Exclusion Criteria

* Potassium level below 3.8 mmol/L measured in serum or plasma
* QTcF interval \>440 ms
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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AZD1305 Medical Science Director

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Aladár Rónaszéki

Role: PRINCIPAL_INVESTIGATOR

Péterfy HospitalDepartment of Cardiology1076 Budapest, Péterfi Sándor str. 8-20HUNGARY

Locations

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Research Site

Brno, CZ, Czechia

Site Status

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Prague, , Czechia

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Znojmo, , Czechia

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Aalborg, , Denmark

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Esbjerg, , Denmark

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Svendborg, , Denmark

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Budapest, , Hungary

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Cegléd, , Hungary

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Debrecen, , Hungary

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Kecskemét, , Hungary

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Székesfehérvár, , Hungary

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Breda, , Netherlands

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Deventer, , Netherlands

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Leeuwarden, , Netherlands

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Sneek, , Netherlands

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Hamar, , Norway

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Oslo, , Norway

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Rud, , Norway

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Tromsø, , Norway

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Bytom, , Poland

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Lubin, , Poland

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Płock, , Poland

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Ruda Śląska, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Martin, , Slovakia

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Nitra, , Slovakia

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Ružomberok, , Slovakia

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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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Czechia Denmark Hungary Netherlands Norway Poland Slovakia Sweden

References

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Ronaszeki A, Alings M, Egstrup K, Gaciong Z, Hranai M, Kiraly C, Sereg M, Figatowski W, Bondarov P, Johansson S, Frison L, Edvardsson N, Berggren A. Pharmacological cardioversion of atrial fibrillation--a double-blind, randomized, placebo-controlled, multicentre, dose-escalation study of AZD1305 given intravenously. Europace. 2011 Aug;13(8):1148-56. doi: 10.1093/europace/eur120. Epub 2011 May 11.

Reference Type DERIVED
PMID: 21561900 (View on PubMed)

Other Identifiers

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2009-009862-15 (EudraCT No)

Identifier Type: -

Identifier Source: secondary_id

D3191C00009

Identifier Type: -

Identifier Source: org_study_id

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