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Explorative Study of AZD1305 in Atrial Fibrillation Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643448
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: AZD1305 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AZD1305 loading dose 250 mg + 125 mg
Tablets
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

Experimental: AZD1305 loading dose 500 mg + placebo
Tablets
Drug: AZD1305
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643448


Locations
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Denmark
Research Site
Aalborg, Denmark
Research Site
Esbjerg, Denmark
Research Site
Hvidovre, Denmark
Research Site
Kobenhavn, Denmark
Research Site
Silkeborg, Denmark
Research Site
Svendborg, Denmark
Norway
Research Site
Oslo, Norway
Research Site
RUD, Norway
Research Site
Tynset, Norway
Poland
Research Site
Bytom, Poland
Research Site
Warszawa, Poland
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Saint-petersburg, Russian Federation
Slovakia
Research Site
Kosice, Slovakia
Research Site
Nitra, Slovakia
Research Site
Nove Zamky, Slovakia
Research Site
Rimavska Sobota, Slovakia
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Kenneth Egstrup Svendborg Sygehus, Forsknings-og udviklingsafd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00643448    
Other Study ID Numbers: D3190C00019
2007-007058-79
First Posted: March 26, 2008    Key Record Dates
Results First Posted: January 26, 2012
Last Update Posted: January 26, 2012
Last Verified: December 2011
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes