Explorative Study of AZD1305 in Atrial Fibrillation Patients
NCT ID: NCT00643448
Last Updated: 2012-01-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2008-03-31
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
NCT00748982
An Interaction Study With Digoxin and AZD1305
NCT00712465
Safety and Tolerability Study of AZD4831 in Patients With Heart Failure.
NCT03756285
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
NCT04986202
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
NCT01396226
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD1305 loading dose 250 mg + 125 mg
Tablets
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 loading dose 500 mg + placebo
Tablets
AZD1305
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
Placebo corresponding to AZD1305 loading dose
Tablets
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sinus rhythm at randomisation
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenneth Egstrup
Role: PRINCIPAL_INVESTIGATOR
Svendborg Sygehus, Forsknings-og udviklingsafd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Aalborg, , Denmark
Research Site
Copenhagen, , Denmark
Research Site
Esbjerg, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Silkeborg, , Denmark
Research Site
Svendborg, , Denmark
Research Site
Oslo, , Norway
Research Site
Rud, , Norway
Research Site
Tynset, , Norway
Research Site
Bytom, , Poland
Research Site
Warsaw, , Poland
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Košice, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Nové Zámky, , Slovakia
Research Site
Rimavská Sobota, , Slovakia
Research Site
Gothenburg, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-007058-79
Identifier Type: -
Identifier Source: secondary_id
D3190C00019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.