Clinical trial NCT00643448: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Maximum QTcF
timeFrame: During treatment days 2-10
Secondary outcomes:
measure: Adverse Events (AE)
timeFrame: During treatment days 2-10
measure: Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state
timeFrame: During treatment days 1-10
measure: Compliance With Trans Telephonic Monitoring (TTM)
timeFrame: During treatment days 1-10
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Silkeborg
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: RUD
country: Norway
facility: Research Site
city: Tynset
country: Norway
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-petersburg
country: Russian Federation
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Svendborg Sygehus, Forsknings-og udviklingsafd.
name: Kenneth Egstrup
role: PRINCIPAL_INVESTIGATOR
References:
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.