Cardiac Electrophysiological Study

Atrial Flutter Clinical Trial

Official title:

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616629
• Other study ID #: D3190C00005
• Secondary ID: 2007-0003455-36
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2008
• Last updated: August 17, 2011
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Drug:
• AZD1305
Intravenous infusion

Locations

Country	Name	City	State
Denmark	Research Site	Aalborg
Denmark	Research Site	Arhus
Denmark	Research Site	Hellerup
Denmark	Research Site	København
Finland	Research Site	Helsinki
Finland	Research Site	Kuopio
Finland	Research Site	Oulu
Norway	Research Site	Bergen
Norway	Research Site	Oslo
Sweden	Research Site	Goteborg
Sweden	Research Site	Linkoping
Sweden	Research Site	Orebro
Sweden	Research Site	Umea

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product	No
Secondary	RAERP (Right Atrial Effective Refractory Period)	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product	No
Secondary	VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product	Yes
Secondary	QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds)	Absolute change, after - before infusion	Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona	Yes
Secondary	Cmax Observed for AZD1305	A total of 13 scheduled PK samples for each patient during and after infusion	During and after infusion	No
Secondary	AUC Total of AZD1305 (Umol*h/L)	A total of 13 scheduled PK samples for each patient during and after infusion	Based on PK samples during and after infusion	No
Secondary	Number of Patients Who Had at Least One AE	Number of patients	During active treatment period	Yes