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

NCT ID: NCT00107900

Last Updated: 2019-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Arthroplasty, Replacement, Hip Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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15mg BID

15mg edoxaban administered twice daily (BID)

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

30mg QD

30mg edoxaban administered once daily (QD)

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

30mg BID

30mg edoxaban administered twice daily (BID)

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

60mg QD

60mg edoxaban administered once daily (QD)

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

60mg BID

60mg edoxaban administered twice daily (BID)

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

120mg QD

120mg edoxaban administered once daily (QD)

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

Interventions

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DU-176b

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo

Locations

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Local Institution

Decatur, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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DU176b-PRT007

Identifier Type: -

Identifier Source: org_study_id

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