Explorative Study of AZD1305 in Atrial Fibrillation Patients

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: AZD1305; Drug: Placebo

• Registration Number: NCT00643448
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-26
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2011-01-24
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-21
• Last Update Submitted: 2011-12-21
• Results First Posted: 2012-01-26
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
• Sinus rhythm at randomisation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD1305 loading dose 250 mg + 125 mg	AZD1305	Tablets
AZD1305 loading dose 500 mg + placebo	AZD1305	Tablets
Placebo corresponding to AZD1305 loading dose	Placebo	Tablets

Primary Outcome Measures

Name	Time	Method
Maximum QTcF	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

Name	Time	Method
Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state	During treatment days 1-10	Population PK model parameter estimates derived from plasma concentrations of AZD1305
Adverse Events (AE)	During treatment days 2-10	Number of patients who had at least one AE according to the definition in the study protocol
Compliance With Trans Telephonic Monitoring (TTM)	During treatment days 1-10	Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden