Study identifier:D1250C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation
Nonvalvular Atrial Fibrillation
Phase 2
No
AZD0837, Vitamin-K antagonist at INR 2-3
All
1084
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 AZD0837 450 mg | Drug: AZD0837 ER tablet, PO, once daily for a period of 3-9 months. Other Name: AZD0837 |
Experimental: 2 AZD0837 200 mg | Drug: AZD0837 ER tablet, PO, twice daily for a period of 3-9 months |
Experimental: 3 AZD0837 300 mg | Drug: AZD0837 ER tablet, PO, once daily for a period of 3-9 months. Other Name: AZD0837 |
Experimental: 4 AZD0837 150 mg | Drug: AZD0837 ER tablet, PO, once daily for a period of 3-9 months. Other Name: AZD0837 |
Active Comparator: 5 Vitamin-K antagonist at INR 2-3 | Drug: Vitamin-K antagonist at INR 2-3 Tablet, PO for a period of 3-9 months. Other Name: Warfarin |
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