A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

Venous Thromboembolism Clinical Trial

Official title:

A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203098
• Other study ID #: DU176b-B-J209
• Status: Completed
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: June 2009

Study information

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

Clinical Trial Summary

The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing unilateral total hip arthroplasty

2. Patients who are 20-84 years olds

Exclusion Criteria:

1. Subjects with risks of hemorrhage

2. Subjects with thromboembolic risks

3. Subjects who weigh less than 40 kg

4. Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Deep Vein Thrombosis
• Embolism
• Embolism and Thrombosis
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• DU-176b 15mg
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
• DU-176b 30mg
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
• Enoxaparin sodium 20 mg (=2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Venous Thromboembolism Events	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.; Lower extremity DVT confirmed by bilateral venography at the end of study treatment; Definite diagnosis of symptomatic PE; Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE	2 weeks
Secondary	Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.		2 weeks