CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,084 enrolled
Drug / intervention
AZD0837 +2 moredrug
Likely dose
Not stated in 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/NCT00684307
NCT00684307Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted May 26, 2008·Updated Mar 23, 2012

In Brief

A Phase 2 clinical trial evaluating AZD0837 and Vitamin-K antagonist at INR 2-3 for Nonvalvular Atrial Fibrillation. Completed, enrolled 1,084 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonvalvular Atrial Fibrillation
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2008
Enrollment StartFeb 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.1 years ago

Interventions

AZD0837drug

ER tablet, PO, once daily for a period of 3-9 months.

Vitamin-K antagonist at INR 2-3drug

Tablet, PO for a period of 3-9 months.

AZD0837drug

ER tablet, PO, twice daily for a period of 3-9 months