Status:
COMPLETED
Long-term Safety in Atrial Fibrillation Patients
Lead Sponsor:
AstraZeneca
Conditions:
Persistent or Permanent Nonvalvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional ...
Eligibility Criteria
Inclusion
- Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
- completing treatment with study drug in D1250C00008.
Exclusion
- Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
- Presence of a 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
- Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
- Conditions associated with increased risk of major bleeding.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
523 Patients enrolled
Trial Details
Trial ID
NCT00645853
Start Date
October 1 2007
End Date
May 1 2009
Last Update
March 23 2012
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