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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398216
• Other study ID #: DU176b-PRT011
• Secondary ID: 2006-000758-29
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: June 2007

Study information

• Verified date: February 2015
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 903
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Replacement
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Hungary,  Latvia,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated Incidence of VTE	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.	end of treatment
Secondary	Change in Prothrombin Time (PT) From Baseline	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	end of treatment
Secondary	Change in Activated Partial Thromboplastin Time (aPTT) From Baseline	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	end of treatment
Secondary	Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events	adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose	10 days after first dose