Explorative Study of AZD1305 in Atrial Fibrillation Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643448

D3190C00019

2007-007058-79

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 3 patient groups, including a placebo group

AZD1305 loading dose 250 mg + 125 mg

Experimental group

Description:

Tablets

Treatment:

Drug: AZD1305

Drug: AZD1305

AZD1305 loading dose 500 mg + placebo

Experimental group

Description:

Tablets

Treatment:

Drug: AZD1305

Drug: AZD1305

Placebo corresponding to AZD1305 loading dose

Placebo Comparator group

Description:

Tablets

Treatment:

Drug: Placebo