Cardiac Electrophysiological Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00616629
First received: February 5, 2008
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Atrial Flutter
Drug: AZD1305
Phase 2

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Absolute change, after - before infusion


Secondary Outcome Measures:
  • RAERP (Right Atrial Effective Refractory Period) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Absolute change, after - before infusion

  • VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    Absolute change, after - before infusion

  • 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) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    Absolute change, after - before infusion

  • Cmax Observed for AZD1305 [ Time Frame: During and after infusion ] [ Designated as safety issue: No ]
    A total of 13 scheduled PK samples for each patient during and after infusion

  • AUC Total of AZD1305 (Umol*h/L) [ Time Frame: Based on PK samples during and after infusion ] [ Designated as safety issue: No ]
    A total of 13 scheduled PK samples for each patient during and after infusion

  • Number of Patients Who Had at Least One AE [ Time Frame: During active treatment period ] [ Designated as safety issue: Yes ]
    Number of patients


Enrollment: 55
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD1305
    Intravenous infusion
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616629

Locations
Denmark
Research Site
Aalborg, Denmark
Research Site
Arhus, Denmark
Research Site
Hellerup, Denmark
Research Site
København, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Kuopio, Finland
Research Site
Oulu, Finland
Norway
Research Site
Bergen, Norway
Research Site
Oslo, Norway
Sweden
Research Site
Gŏteborg, Sweden
Research Site
Linkŏping, Sweden
Research Site
Umea, Sweden
Research Site
Ŏrebro, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lauri Toivonen, MD Helsinki University Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca AZD1305 Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00616629     History of Changes
Other Study ID Numbers: D3190C00005, 2007-0003455-36 (EudraCT No)
Study First Received: February 5, 2008
Results First Received: January 24, 2011
Last Updated: August 17, 2011
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014