臨床研究等提出・公開システム

Date of registration	June. 09, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220743

Scientific Title	DU-176b Phase III Clinical Study (Venous Thromboembolism) Randomized Double-Blind Study of DU-176b in Patients Undergoing Total Hip Arthroplasty with Enoxaparin as an Active Control
Public Title	DU-176b Phase III Clinical Study (Venous Thromboembolism) Randomized Double-Blind Study of DU-176b in Patients Undergoing Total Hip Arthroplasty with Enoxaparin as an Active Control

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		600
Study Type		Interventional
Study Design	Study Design	Double- blinded, parallel group controlled study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing unilateral total hip arthroplasty
	Exclusion Criteria	-Subjects with risks of hemorrhage -Subjects with thromboembolic risks -Subjects who weigh less than 40 kg -Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
	Minimum Age	20age old over
	Maximum Age	84age old under
	Gender	Both
Health Condition or Problem Studied		Patients undergoing total hip arthroplasty
Intervention(s)		investigational material(s) Generic name etc : DU-176b INN of investigational material : edoxaban Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Enoxaparin sodium INN of investigational material : enoxaparin sodium Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material : 20mg (=2000IU) / 0.2ml twice daily, subcutaneous
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Proportion of subjects with venous thromboembolism events
Secondary Outcome		Proportion of subjects with bleeding events

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090771
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	July. 31, 2014	Detail	Changes
7	July. 31, 2014	Detail	Changes
6	Feb. 07, 2011	Detail	Changes
5	Feb. 07, 2011	Detail	Changes
4	Mar. 26, 2010	Detail	Changes
3	Mar. 26, 2010	Detail	Changes
2	June. 16, 2009	Detail	Changes
1	June. 09, 2009	Detail

List of change history