Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation
Study identifier:D1250C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Nonvalvular Atrial Fibrillation
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD0837, Vitamin-K antagonist at INR 2-3
Sex
All
Actual Enrollment
1084
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Feb 2007
Primary Completion Date: 01 Jun 2008
Study Completion Date: 01 Jun 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
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 |
Contacts
Investigators
Principal Investigator
Gregory Y Lip
University Department of Medicine, City Hospital, Birmingham, B18 7QH, England, UK
