NCT00643448

Brief Summary

Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state

Trial Health

93
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for phase_2 atrial-fibrillation

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
6 countries

18 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

March 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 26, 2012

Completed
Last Updated

January 26, 2012

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

March 20, 2008

Results QC Date

January 24, 2011

Last Update Submit

December 21, 2011

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Maximum QTcF

    Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.

    During treatment days 2-10

Secondary Outcomes (3)

  • Adverse Events (AE)

    During treatment days 2-10

  • Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state

    During treatment days 1-10

  • Compliance With Trans Telephonic Monitoring (TTM)

    During treatment days 1-10

Study Arms (3)

AZD1305 loading dose 250 mg + 125 mg

EXPERIMENTAL

Tablets

Drug: AZD1305

AZD1305 loading dose 500 mg + placebo

EXPERIMENTAL

Tablets

Drug: AZD1305

Placebo corresponding to AZD1305 loading dose

PLACEBO COMPARATOR

Tablets

Drug: Placebo

Interventions

AZD1305DRUG

AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2

AZD1305 loading dose 250 mg + 125 mg
PlaceboDRUG

Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2

Placebo corresponding to AZD1305 loading dose

Eligibility Criteria

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

You may qualify if:

  • Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
  • Sinus rhythm at randomisation

You may not qualify if:

  • Haemodynamically unstable condition as judged by the Investigator, systolic BP \<100 mmHg or \>180 mmHg, or diastolic BP \>105 mmHg at randomisation
  • Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
  • Sinus bradycardia (\<50 beats per minute (bpm)) at randomisation
  • 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
  • Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Aalborg, Denmark

Location

Research Site

Copenhagen, Denmark

Location

Research Site

Esbjerg, Denmark

Location

Research Site

Hvidovre, Denmark

Location

Research Site

Silkeborg, Denmark

Location

Research Site

Svendborg, Denmark

Location

Research Site

Oslo, Norway

Location

Research Site

Rud, Norway

Location

Research Site

Tynset, Norway

Location

Research Site

Bytom, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Košice, Slovakia

Location

Research Site

Nitra, Slovakia

Location

Research Site

Nové Zámky, Slovakia

Location

Research Site

Rimavská Sobota, Slovakia

Location

Research Site

Gothenburg, Sweden

Location

Related Publications (1)

  • Egstrup K, Bergfeldt L, Duris T, Gullestad L, Kochmanski M, Kusnierz B, Nielsen T, Sawicki S, Aunes-Jansson M, Edvardsson N, Frison L, Johansson S, Berggren A. QT response after a test dose and during maintenance therapy with AZD1305 in patients with atrial fibrillation: a double-blind, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2011 Jun 1;11(3):199-208. doi: 10.2165/11591750-000000000-00000.

    PMID: 21619383DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

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

  • Kenneth Egstrup

    Svendborg Sygehus, Forsknings-og udviklingsafd.

    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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 26, 2012

Results First Posted

January 26, 2012

Record last verified: 2011-12

Locations

SE(1)RU(2)DK(6)SL(4)PL(2)NO(3)