臨床研究等提出・公開システム

Date of registration	Dec. 15, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221674

Scientific Title	Phase III Clinical Study of DU-176b (non-valvular atrial fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients with non-valvular atrial fibrillation and Severe Renal Impairment
Public Title

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 Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		90
Study Type		Interventional
Study Design	Study Design	Multicenter, open-label, parallel-group, comparative study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with non-valvular atrial fibrillation and severe renal impairment, or normal renal function or mild renal impairment
	Exclusion Criteria	-Patients on hemodialysis or patients who may start hemodialysis before the follow-up assessment -Patients at risk for bleeding -Patients who are receiving treatment with any anticoagulant drugs excluding warfarin and dabigatran -Patients with evidence of hepatic dysfunction
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Non-valvular 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 : <Patients with severe renal impairment>DU-176b will be orally administered at a dose of 15 mg once daily for 12 weeks.,<Patients with normal renal function or mild renal impairment>Low-dose group: DU-176b will be orally administered at a dose of 30 mg once daily for 12 weeks; in subjects who have any dose adjustment factor (body weight of =<60 kg or the presence of concurrent treatment with quinidine or verapamil), DU-176b will be orally administered at a dose of 15 mg once daily for 12 weeks, irrespective of the number of dose adjustment factors.,High-dose group: DU-176b will be orally administered at a dose of 60 mg once daily for 12 weeks; in subjects who have any dose adjustment factor (body weight of =<60 kg or the presence of concurrent treatment with quinidine or verapamil), DU-176b will be orally administered at a dose of 30 mg once daily for 12 weeks, irrespective of the number of dose adjustment factors.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety endpoints[Incidence of all bleeding events, adverse events and adverse drug reactions]
Secondary Outcome

Primary Sponsor	DAIICHI SANKYO 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-111716
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	April. 26, 2013	Detail	Changes
5	April. 26, 2013	Detail	Changes
4	Jan. 11, 2013	Detail	Changes
3	Jan. 11, 2013	Detail	Changes
2	Dec. 15, 2011	Detail	Changes
1	Dec. 15, 2011	Detail

List of change history