Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915356

D3191C00009

2009-009862-15 (EudraCT No)

Details and patient eligibility

About

This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.

Enrollment: 228 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
• Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
• Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines

Exclusion criteria

• Potassium level below 3.8 mmol/L measured in serum or plasma
• QTcF interval >440 ms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD1305 iv infusion

Treatment:

Drug: AZD1305

2

Placebo Comparator group

Description:

Placebo iv infusion

Treatment:

Drug: Placebo