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

Stopped early · Phase 2

Conditions studied: Stroke Prevention in Patients With Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT00206063

Run by

AstraZeneca

People needed

220

Starts

1999-08-01

Expected to finish

2006-04-01

Last updated by the study team

2010-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Research Site — Palo Alto, California, United States
• Research Site — Oostduinkerke, Belgium
• Research Site — Helsingor, Czechia
• Research Site — Most, Czechia
• Research Site — Plzeo, Czechia
• Research Site — Poibram, Czechia
• Research Site — Prague, Czechia
• Research Site — Aarhus, Denmark
• Research Site — Odense, Denmark
• Research Site — Kuopio, Finland
• Research Site — Savonlinna, Finland
• Research Site — Hamar, Norway
• Research Site — Oslo, Norway
• Research Site — Płock, Poland
• Research Site — Siedice, Poland
• Research Site — Warsaw, Poland
• Research Site — Lund, Sweden
• Research Site — Leicester, United Kingdom
• Research Site — Newcastle, United Kingdom

Full record on ClinicalTrials.gov

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