Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

Thrombosis Clinical Trial

Official title:

A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107900
• Other study ID #: DU176b-PRT007
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: December 2005

Study information

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

Clinical Trial Summary

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

Description:

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unilateral hip replacement

Exclusion Criteria:

• Patients scheduled for bilateral hip replacement in same procedure

• Patients with increased risk of bleeding

• Uncontrolled hypertension (BP greater than 180/100 mmHg)

• Patients less than 111 lbs or more than 243 lbs

• Patients on long-term anticoagulants

• Patients with contraindications to venography

• Patients with medical history of venous thromboembolism

• Patients with impaired hepatic function

• Known to be pregnant

• Lactating women

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Thrombosis

Intervention

Drug:
• DU-176b

Locations

Country	Name	City	State
United States	Local Institution	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of Venous Thromboembolism (VTE)	The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery).; Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography	2 weeks
Secondary	Change From Baseline for Prothrombin Time (PT) Results	Intent to Treat (ITT) population	end of treatment
Secondary	Change From Baseline for International Normalized Ratio (INR) Results	Intent to Treat (ITT) population	end of treatment
Secondary	Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results	Intent to Treat (ITT) population	end of treatment