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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00398216
First received: November 9, 2006
Last updated: February 5, 2015
Last verified: February 2015
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Adjudicated Incidence of VTE [ Time Frame: end of treatment ] [ Designated as safety issue: No ]

    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:
  • Change in Prothrombin Time (PT) From Baseline [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
    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

  • Change in Activated Partial Thromboplastin Time (aPTT) From Baseline [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
    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

  • Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events [ Time Frame: 10 days after first dose ] [ Designated as safety issue: Yes ]
    adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose


Enrollment: 903
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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     History of Changes
Other Study ID Numbers: DU176b-PRT011  2006-000758-29 
Study First Received: November 9, 2006
Results First Received: February 5, 2015
Last Updated: February 5, 2015
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
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

ClinicalTrials.gov processed this record on December 02, 2016