MedDataX Logo

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

NCT ID: NCT00206063

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Prevention in Patients With Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EXANTA

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ximelagatran

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Palo Alto, California, United States

Site Status

Research Site

Oostduinkerke, , Belgium

Site Status

Research Site

Helsingor, , Czechia

Site Status

Research Site

Most, , Czechia

Site Status

Research Site

Plzeo, , Czechia

Site Status

Research Site

Poibram, , Czechia

Site Status

Research Site

Prague, , Czechia

Site Status

Research Site

Aarhus, , Denmark

Site Status

Research Site

Odense, , Denmark

Site Status

Research Site

Kuopio, , Finland

Site Status

Research Site

Savonlinna, , Finland

Site Status

Research Site

Hamar, , Norway

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Płock, , Poland

Site Status

Research Site

Siedice, , Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Research Site

Lund, , Sweden

Site Status

Research Site

Leicester, , United Kingdom

Site Status

Research Site

Newcastle, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Czechia Denmark Finland Norway Poland Sweden United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D4004C00004

Identifier Type: -

Identifier Source: secondary_id

SH-TPA-0004

Identifier Type: -

Identifier Source: org_study_id