NCT01396226

Brief Summary

Medical Products Agency

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 23, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

July 13, 2011

Results QC Date

September 24, 2012

Last Update Submit

November 22, 2012

Conditions

Arrhythmia

Keywords

Atrial refractorinesscardiac electrophysiologyIKACh

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Ventricular Effective Refractory Period

    Baseline to last assessment during IP infusion

  • Paced QT Interval

    Baseline to last assessment during IP infusion

  • Atrio-ventricular Effective Refractory Period

    Baseline to last assessment during IP infusion

  • PA Interval

    Baseline to last assessment during IP infusion

  • AH Interval

    Baseline to last assessment during IP infusion

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

A single dose of AZD2927 administered as an iv infusion

Drug: AZD2927

2

PLACEBO COMPARATOR

A single dose of placebo administered as an iv infusion

Drug: Placebo

Interventions

AZD2927DRUG

A single dose of AZD2927 administered as an iv infusion

1
PlaceboDRUG

A single dose of placebo administered as an iv infusion

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Oslo, Norway

Location

Research Site

Linköping, Sweden

Location

Research Site

Örebro, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Umeå, Sweden

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

AZD2927

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Stefan C Carlsson, MD, PHD

    AstraZeneca

    STUDY DIRECTOR

  • Hakan Walfridsson, MD, PHD

    University Hospital Linkoping Sweden

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 18, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 27, 2012

Results First Posted

October 23, 2012

Record last verified: 2012-11

Locations

NO(1)SE(4)