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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Arrhythmia

Treatments: Drug: AZD2927; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396226

D4120C00002

2011-001716-59 (EudraCT Number)

Details and patient eligibility

About

Medical Products Agency

Full description

• 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

A single dose of AZD2927 administered as an iv infusion

Treatment:

Drug: AZD2927

2

Placebo Comparator group

Description:

A single dose of placebo administered as an iv infusion

Treatment:

Drug: Placebo