CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 523 enrolled
Drug / intervention
AZD0837 +1 moredrug
Likely dose
AZD0837 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00645853
NCT00645853Phase 2Completed
CompareCT.gov

Long-term Treatment With the Oral Direct Thrombin Inhibitor AZD0837, Compared to Vitamin-K Antagonists, as Stroke Prevention in Patients With Non-valvular Atrial Fibrillation and One or More Risk Factors for Stroke and Systemic Embolic Events. A 5-year Follow-up Study

AstraZeneca·interventional·Posted Mar 28, 2008·Updated Mar 23, 2012

In Brief

A Phase 2 clinical trial evaluating AZD0837 and VKA INR 2-3 for Persistent or Permanent Nonvalvular Atrial Fibrillation. Completed, enrolled 523 participants.

Detailed 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 risk factors for stroke and systemic embolic events (moderate to high risk patients).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent or Permanent Nonvalvular Atrial Fibrillation
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2008
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.3 years ago

Interventions

AZD0837drug

Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od

VKA INR 2-3drug

Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5