Explorative Study of AZD1305 in Atrial Fibrillation Patients

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643448
• Other study ID #: D3190C00019
• Secondary ID: 2007-007058-79
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2008
• Last updated: December 21, 2011
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencySlovakia: State Institute for Drug ControlRussia: Ministry of Health of the Russian FederationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• AZD1305
AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
• AZD1305
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
• Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2

Locations

Country	Name	City	State
Denmark	Research Site	Aalborg
Denmark	Research Site	Esbjerg
Denmark	Research Site	Hvidovre
Denmark	Research Site	Kobenhavn
Denmark	Research Site	Silkeborg
Denmark	Research Site	Svendborg
Norway	Research Site	Oslo
Norway	Research Site	RUD
Norway	Research Site	Tynset
Poland	Research Site	Bytom
Poland	Research Site	Warszawa
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint-petersburg
Slovakia	Research Site	Kosice
Slovakia	Research Site	Nitra
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Rimavska Sobota
Sweden	Research Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Norway,  Poland,  Russian Federation,  Slovakia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Adverse Events (AE)	Number of patients who had at least one AE according to the definition in the study protocol	During treatment days 2-10	Yes
Secondary	Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state	Population PK model parameter estimates derived from plasma concentrations of AZD1305	During treatment days 1-10	No
Secondary	Compliance With Trans Telephonic Monitoring (TTM)	Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis	During treatment days 1-10	No