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

This study has been completed.

First Received: November 9, 2006 Last Updated: December 12, 2007 History of Changes

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00398216

Purpose

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.

Condition	Intervention	Phase
Thrombosis Hip Replacement	Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Antithrombin III

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

The primary objective of this study is to assess the efficacy of DU-176b in the prevention of VTE.

Secondary Outcome Measures:

The secondary objectives are to compare the incidence of VTE and major and clinically relevant non-major bleeds of DU-176b to dalteparin and to assess the PK and PD properties of DU-176b.

Estimated Enrollment:	950
Study Start Date:	May 2006
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

18 years of age or older; male or female.
Able to provide written informed consent.
Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398216

Locations

United States, Connecticut

Hartford, Connecticut, United States
United States, Florida

Sarasota, Florida, United States
United States, Texas

Austin, Texas, United States
Canada, Ontario

Ajax, Ontario, Canada

Toronto, Ontario, Canada

Kitchner, Ontario, Canada

Guelph, Ontario, Canada

Cambridge, Ontario, Canada
Denmark

Herlev, Denmark

Horsholm, Denmark

Hellerup, Denmark
Hungary

Gyula, Hungary

Kecskemet, Hungary

Szeged, Hungary
Latvia

Riga, Latvia
Russian Federation

St. Petersburg, Russian Federation

Volgograd, Russian Federation

Krasnoyarsk, Russian Federation

Saratov, Russian Federation

Velikij Novgorod, Russian Federation

Moscow, Russian Federation
Ukraine

Dnepropetrovsk, Ukraine

Kiev, Ukraine

Lutsk, Ukraine

Kharkiv, Ukraine

Donetsk, Ukraine

Odessa, Ukraine

Kharkov, Ukraine

Chernivtsy, Ukraine

Lviv, Ukraine

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Daiichi Sankyo ( Anne MacDonald )
Study ID Numbers:	DU176b-PRT011, STARTS II, - Studying, Thrombosis After, Replacement Surgery
Study First Received:	November 9, 2006
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00398216 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Anti-coagulant
hip replacement
hip replacement surgery
unilateral hip replacement surgery
DeepVein Thrombosis

Venous Thromboembolism
PE
Prevention of Blood Clots
Unilateral Hip Replacement

Study placed in the following topic categories:

Serine Proteinase Inhibitors
Embolism and Thrombosis
Anticoagulants
Dalteparin
Embolism
Vascular Diseases

Venous Thromboembolism
Antithrombin III
Serine
Thromboembolism
Thrombosis
Protease Inhibitors

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Enzyme Inhibitors
Thrombosis

Pharmacologic Actions
Protease Inhibitors
Embolism and Thrombosis
Therapeutic Uses
Cardiovascular Diseases
Antithrombin III

ClinicalTrials.gov processed this record on September 11, 2009