Explorative Study of AZD1305 in Atrial Fibrillation Patients
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1305
AZD1305
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
- Sinus rhythm at randomisation
Exclusion Criteria:
- 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AZD1305 loading dose 250 mg + 125 mg
AZD1305 loading dose 500 mg + placebo
Placebo corresponding to AZD1305 loading dose
Arm Description
Tablets
Tablets
Tablets
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adverse Events (AE)
Number of patients who had at least one AE according to the definition in the study protocol
Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state
Population PK model parameter estimates derived from plasma concentrations of AZD1305
Compliance With Trans Telephonic Monitoring (TTM)
Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643448
Brief Title
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Official Title
A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship Between QTcF Interval at First Dose (Loading Dose) and at Steady State After Treatment With AZD1305 Extended-release Tablets or Placebo When Given to Patients With Documented AF
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD1305 loading dose 250 mg + 125 mg
Arm Type
Experimental
Arm Description
Tablets
Arm Title
AZD1305 loading dose 500 mg + placebo
Arm Type
Experimental
Arm Description
Tablets
Arm Title
Placebo corresponding to AZD1305 loading dose
Arm Type
Placebo Comparator
Arm Description
Tablets
Intervention Type
Drug
Intervention Name(s)
AZD1305
Intervention Description
AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
Intervention Type
Drug
Intervention Name(s)
AZD1305
Intervention Description
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
Primary Outcome Measure Information:
Title
Maximum QTcF
Description
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
Time Frame
During treatment days 2-10
Secondary Outcome Measure Information:
Title
Adverse Events (AE)
Description
Number of patients who had at least one AE according to the definition in the study protocol
Time Frame
During treatment days 2-10
Title
Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state
Description
Population PK model parameter estimates derived from plasma concentrations of AZD1305
Time Frame
During treatment days 1-10
Title
Compliance With Trans Telephonic Monitoring (TTM)
Description
Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis
Time Frame
During treatment days 1-10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
Sinus rhythm at randomisation
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Egstrup
Organizational Affiliation
Svendborg Sygehus, Forsknings-og udviklingsafd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Esbjerg
Country
Denmark
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
Country
Denmark
Facility Name
Research Site
City
Silkeborg
Country
Denmark
Facility Name
Research Site
City
Svendborg
Country
Denmark
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
RUD
Country
Norway
Facility Name
Research Site
City
Tynset
Country
Norway
Facility Name
Research Site
City
Bytom
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint-petersburg
Country
Russian Federation
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
Country
Slovakia
Facility Name
Research Site
City
Goteborg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21619383
Citation
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.
Results Reference
derived
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Explorative Study of AZD1305 in Atrial Fibrillation Patients
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