臨床研究等提出・公開システム

Date of registration	June. 12, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220747

Scientific Title	A Phase 3, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillation - Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE AF-TIMI 48)
Public Title	A Phase 3, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillation

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/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		20500
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Documented AF on ECG
	Exclusion Criteria	- Subjects with any contraindication for anticoagulant agents - Subjects with conditions associated with high risk of bleeding - Females of childbearing potential
	Minimum Age	21age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Patients with atrial fibrillation
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 : Warfarin INN of investigational material : warfarin Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material : once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		The composite primary endpoint of stroke and systemic embolic events.
Secondary Outcome		- The composite clinical outcome of stroke, SEE, and all-cause mortality. - Major bleeding events

Primary Sponsor	DAIICHISANKYO Co.,Ltd., DAIICHI SANKYO PHARMA DEVELOPMENT
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-090775
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	Sept. 03, 2014	Detail	Changes
11	July. 31, 2014	Detail	Changes
10	July. 31, 2014	Detail	Changes
9	July. 31, 2014	Detail	Changes
8	July. 29, 2014	Detail	Changes
7	July. 29, 2014	Detail	Changes
6	Feb. 07, 2011	Detail	Changes
5	Feb. 07, 2011	Detail	Changes
4	June. 07, 2010	Detail	Changes
3	June. 07, 2010	Detail	Changes
2	June. 15, 2009	Detail	Changes
1	June. 12, 2009	Detail

List of change history