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Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

NCT00684307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1084

Last updated 2012-03-23

Study results available
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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

  • Nonvalvular Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gregory Y Lip, Prof · University Department of Medicine, City Hospital, Birmingham, B18 7QH, England, UK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-06-30
Completion
2008-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00684307 on ClinicalTrials.gov