Trials / Completed
CompletedNCT00684307
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,084 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD0837 | ER tablet, PO, once daily for a period of 3-9 months. |
| DRUG | Vitamin-K antagonist at INR 2-3 | Tablet, PO for a period of 3-9 months. |
| DRUG | AZD0837 | ER tablet, PO, twice daily for a period of 3-9 months |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2008-05-26
- Last updated
- 2012-03-23
- Results posted
- 2011-09-22
Source: ClinicalTrials.gov record NCT00684307. Inclusion in this directory is not an endorsement.