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

NCT ID: NCT01203072

Last Updated: 2019-02-25

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

523 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-07-31

Brief Summary

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The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Detailed Description

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Conditions

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Venous Thromboembolism Deep Vein Thrombosis Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DU-176b 5 mg

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

DU-176b 5mg tablets oral, once daily for 2 weeks

DU-176b 15 mg

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

DU-176b 15mg tablets, oral once daily for 2 weeks

DU-176b 30 mg

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

DU-176b 30 mg tablets, oral, once daily for 2 weeks

DU-176b 60 mg

Group Type EXPERIMENTAL

DU-176b

Intervention Type DRUG

DU-176b 60 mg tablets, oral, once daily for 2 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo oral tablets, once daily for 2 weeks

Interventions

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DU-176b

DU-176b 5mg tablets oral, once daily for 2 weeks

Intervention Type DRUG

DU-176b

DU-176b 15mg tablets, oral once daily for 2 weeks

Intervention Type DRUG

DU-176b

DU-176b 30 mg tablets, oral, once daily for 2 weeks

Intervention Type DRUG

DU-176b

DU-176b 60 mg tablets, oral, once daily for 2 weeks

Intervention Type DRUG

Placebo

Matching placebo oral tablets, once daily for 2 weeks

Intervention Type DRUG

Other Intervention Names

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edoxaban edoxaban edoxaban edoxaban

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria

* risks of hemorrhage
* thromboembolic risks
* weight less than 40 kg
* pregnant, suspect pregnancy, or subjects who want to become pregnant
Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Takeshi Fuji, Director

Role: PRINCIPAL_INVESTIGATOR

Osaka Koseinekin Hospital

Locations

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Osaka, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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DU176b-04

Identifier Type: -

Identifier Source: org_study_id

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