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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01396226
Other study ID # D4120C00002
Secondary ID 2011-001716-59
Status Completed
Phase Phase 2
First received July 13, 2011
Last updated November 22, 2012
Start date September 2011
Est. completion date January 2012

Study information

Verified date November 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencySweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

Medical Products Agency


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD2927
A single dose of AZD2927 administered as an iv infusion
Placebo
A single dose of placebo administered as an iv infusion

Locations

Country Name City State
Norway Research Site Oslo
Sweden Research Site Linköping
Sweden Research Site Örebro
Sweden Research Site Stockholm
Sweden Research Site Umeå

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left Atrial Effective Refractory Period Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion Baseline to last assessment during IP infusion No
Secondary Ventricular Effective Refractory Period Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion Baseline to last assessment during IP infusion No
Secondary Paced QT Interval Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements Baseline to last assessment during IP infusion No
Secondary Atrio-ventricular Effective Refractory Period Change from observation before IP infusion to during 1st and 2nd LAERP Mean Baseline to last assessment during IP infusion No
Secondary PA Interval Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start Baseline to last assessment during IP infusion No
Secondary AH Interval Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time. Baseline to last assessment during IP infusion No
Secondary HV Interval Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time. Baseline to last assessment during IP infusion No
Secondary PR Interval Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion Baseline to last assessment during IP infusion No
Secondary QRS Duration Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion Baseline to last assessment during IP infusion No
Secondary RR Interval Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion Baseline to last assessment during IP infusion No
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