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Completed

NCT Number: NCT00643448

Explorative Study of AZD1305 in Atrial Fibrillation Patients

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1305

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Maximum QTcF

    Time frame: During treatment days 2-10

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

Secondary outcomes

  1. Adverse Events (AE)

    Time frame: During treatment days 2-10

    Number of patients who had at least one AE according to the definition in the study protocol

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

    Time frame: During treatment days 1-10

    Population PK model parameter estimates derived from plasma concentrations of AZD1305

  3. Compliance With Trans Telephonic Monitoring (TTM)

    Time frame: During treatment days 1-10

    Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2008
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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