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

Phase 2

Completed

• Conditions: Thrombosis; Arthroplasty, Replacement, Hip
• Interventions: Drug: DU-176b

• Registration Number: NCT00107900
• Lead Sponsor: Daiichi Sankyo

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-04-11
• Study First Submitted QC: 2005-04-11
• Study First Posted: 2005-04-12
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2015-02
• Results First Submitted: 2015-02-05
• Results First Submitted QC: 2015-02-26
• Results First Posted: 2015-03-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 606

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60mg BID	DU-176b	60mg edoxaban administered twice daily (BID)
15mg BID	DU-176b	15mg edoxaban administered twice daily (BID)
30mg QD	DU-176b	30mg edoxaban administered once daily (QD)
120mg QD	DU-176b	120mg edoxaban administered once daily (QD)
60mg QD	DU-176b	60mg edoxaban administered once daily (QD)
30mg BID	DU-176b	30mg edoxaban administered twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Prevention of Venous Thromboembolism (VTE)	2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for Prothrombin Time (PT) Results	end of treatment	Intent to Treat (ITT) population
Change From Baseline for International Normalized Ratio (INR) Results	end of treatment	Intent to Treat (ITT) population
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results	end of treatment	Intent to Treat (ITT) population

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Decatur, Georgia, United States