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

November 10, 2010 updated by: AstraZeneca

Long-Term Treatment With the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients With Atrial Fibrillation. A Long Term Follow-Up Study

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-TPA-0004
  • D4004C00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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