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

• ClinicalTrials.gov Identifier: NCT00398216
• Recruitment Status: Completed
• First Posted: November 10, 2006
• Results First Posted: February 25, 2015
• Last Update Posted: February 26, 2019
• Sponsor: Daiichi Sankyo, Inc.
• Information provided by: Daiichi Sankyo, Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Thrombosis; Hip Replacement	Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 903 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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
• Study Start Date: May 2006
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Adjudicated Incidence of VTE [ Time Frame: end of treatment ]

   Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.

   A subject was judged to have a VTE if one or more of the following criteria were met:

   • Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit
   • Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit
   • Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery.

Secondary Outcome Measures :

1. Change in Prothrombin Time (PT) From Baseline [ Time Frame: end of treatment ]
   change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery
2. Change in Activated Partial Thromboplastin Time (aPTT) From Baseline [ Time Frame: end of treatment ]
   change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery
3. Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events [ Time Frame: 10 days after first dose ]
   adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

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

Cambridge, Ontario, Canada

Guelph, Ontario, Canada

Kitchner, Ontario, Canada

Toronto, Ontario, Canada

Denmark

Hellerup, Denmark

Herlev, Denmark

Horsholm, Denmark

Hungary

Gyula, Hungary

Kecskemet, Hungary

Szeged, Hungary

Latvia

Riga, Latvia

Russian Federation

Krasnoyarsk, Russian Federation

Moscow, Russian Federation

Saratov, Russian Federation

St. Petersburg, Russian Federation

Velikij Novgorod, Russian Federation

Volgograd, Russian Federation

Ukraine

Chernivtsy, Ukraine

Dnepropetrovsk, Ukraine

Donetsk, Ukraine

Kharkiv, Ukraine

Kharkov, Ukraine

Kiev, Ukraine

Lutsk, Ukraine

Lviv, Ukraine

Odessa, Ukraine

Sponsors and Collaborators

Daiichi Sankyo, Inc.

More Information

• Responsible Party: Anne MacDonald, Daiichi Sankyo
• ClinicalTrials.gov Identifier: NCT00398216
• Other Study ID Numbers: DU176b-PRT011; 2006-000758-29 ( EudraCT Number )
• First Posted: November 10, 2006
• Results First Posted: February 25, 2015
• Last Update Posted: February 26, 2019
• Last Verified: February 2015

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• URL: https://vivli.org/ourmember/daiichi-sankyo/

Keywords provided by Daiichi Sankyo, Inc.:

Anti-coagulant; hip replacement; hip replacement surgery; unilateral hip replacement surgery; DeepVein Thrombosis; Venous Thromboembolism; pulmonary embolism; Prevention of Blood Clots

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Edoxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants