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NCT Number: NCT00398216

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

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.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Hip Replacement Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ajax, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

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

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 10, 2006
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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