A Controlled, Randomised, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837 in the Prevention of Stroke and other Thromboembolic Complications Associated with Atrial Fibrillation. - N/A

• Conditions: Prevention of stroke and other thromboembolic complications associated with Atrial Fibrillation; MedDRA version: 7.0Level: PTClassification code 10003658

• Registration Number: EUCTR2004-000359-41-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Paroxysmal, persisitent or permanent non valvular Atrial Fibrillation, verified by at least two ECGs in the last year separated by at least one week.

At least one risk factor for stroke, in addition to Atrial Fibrillation.

Age 65 years or more, and diabetes mellitus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age less than 18 years

Weight less than 50 kg, or more than 120 kg

Female of child-bearing potential

Atrial Fibrillation secondary to reversible disorders

Presence of valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment

MI, CABG or PCI within the previous 3 months from visit 1

Stroke or TIA and/or systemic embolism within the previous 6 months from visit 1

Conditions associated with increased risk of bleeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety and tolerability of two different doses of AZD0837 in relation to warfarin during 3 months of treatment in Atrial Fibrillation patients with moderately increased risk of stroke.;Secondary Objective: To evaluate the pharmacokinetics of the active form of AZD0837 (AR-H067637XX) with special regard to variablility in the patient population.<br><br>To evaluate the pharmacodynamics of AZD0837 in the patient population.;Primary end point(s): N/A