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

Phase 2

Completed

• Conditions: Hip Replacement; Thrombosis

• Registration Number: NCT00398216
• Lead Sponsor: Daiichi Sankyo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2015-02
• Results First Submitted: 2015-02-05
• Results First Submitted QC: 2015-02-05
• Results First Posted: 2015-02-25
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 903

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adjudicated Incidence of VTE	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

Name	Time	Method
Change in Prothrombin Time (PT) From Baseline	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
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline	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
Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events	10 days after first dose	adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose