NCT00616629

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
4 countries

13 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

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 22, 2011

Completed
Last Updated

September 22, 2011

Status Verified

August 1, 2011

Enrollment Period

5 months

First QC Date

February 5, 2008

Results QC Date

January 24, 2011

Last Update Submit

August 17, 2011

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • RAERP (Right Atrial Effective Refractory Period)

    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

  • VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)

    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

  • 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)

    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

  • Cmax Observed for AZD1305

    During and after infusion

  • AUC Total of AZD1305 (Umol*h/L)

    Based on PK samples during and after infusion

  • +1 more secondary outcomes

Interventions

AZD1305DRUG

Intravenous infusion

Eligibility Criteria

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

You may qualify if:

  • Patients with atrial flutter (with a ventricular rate of \<100 beats/minute at enrolment), scheduled for curative catheter ablation
  • Sinus rhythm at randomisation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Aalborg, Denmark

Location

Research Site

Aarhus, Denmark

Location

Research Site

Copenhagen, Denmark

Location

Research Site

Hellerup, Denmark

Location

Research Site

Helsinki, Finland

Location

Research Site

Kuopio, Finland

Location

Research Site

Oulu, Finland

Location

Research Site

Bergen, Norway

Location

Research Site

Oslo, Norway

Location

Research Site

Gŏteborg, Sweden

Location

Research Site

Linkŏping, Sweden

Location

Research Site

Ŏrebro, Sweden

Location

Research Site

Umeå, Sweden

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Lauri Toivonen, MD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 22, 2011

Results First Posted

September 22, 2011

Record last verified: 2011-08

Locations

NO(2)SE(4)FI(3)DK(4)