Long Term Open Follow-up With H376/95 vs. Warfarin

Phase 2

Terminated

• Conditions: Stroke Prevention in Patients With Atrial Fibrillation

• Registration Number: NCT00206063
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-08
• Primary Completion: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-04
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Signed informed consent.
• Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)

Exclusion Criteria

• Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Newcastle, United Kingdom