A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery

NCT ID: NCT00398216

Last Updated: 2019-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

903 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-06-30

Brief Summary

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

This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

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.

Thrombosis Hip Replacement

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

DOUBLE

Interventions

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

DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. 18 years of age or older; male or female.
2. Able to provide written informed consent.
3. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
4. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.
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.

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daiichi Sankyo

Locations

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

Hartford, Connecticut, United States

Site Status

Sarasota, Florida, United States

Site Status

Austin, Texas, United States

Site Status

Ajax, Ontario, Canada

Site Status

Cambridge, Ontario, Canada

Site Status

Guelph, Ontario, Canada

Site Status

Kitchner, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Hellerup, , Denmark

Site Status

Herlev, , Denmark

Site Status

Hørsholm, , Denmark

Site Status

Gyula, , Hungary

Site Status

Kecskemét, , Hungary

Site Status

Szeged, , Hungary

Site Status

Riga, , Latvia

Site Status

Krasnoyarsk, , Russia

Site Status

Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saratov, , Russia

Site Status

Veliky Novgorod, , Russia

Site Status

Volgograd, , Russia

Site Status

Chernivtsy, , Ukraine

Site Status

Dnipro, , Ukraine

Site Status

Donetsk, , Ukraine

Site Status

Kharkiv, , Ukraine

Site Status

Kiev, , Ukraine

Site Status

Lutsk, , Ukraine

Site Status

Lviv, , Ukraine

Site Status

Odesa, , Ukraine

Site Status

Countries

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

United States Canada Denmark Hungary Latvia Russia Ukraine

Other Identifiers

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

2006-000758-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DU176b-PRT011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.