臨床研究等提出・公開システム

Date of registration	Sept. 05, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220027

Scientific Title	CS-866DM phase 3 comparative study (ORIENT)
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 COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Double blind comparative study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Inclusion criteria: -Patient, age 30-70. -Albumin-to-creatinine ratio >=300 mg/g-creatinine in first morning urinalysis -Serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men
	Exclusion Criteria	Exclusion criteria: -History of cerebrovascular or cardiovascular disease -Rapid progression of kidney disease within 3 months -Patient with extremely poor glycemic control
	Minimum Age	30age old over
	Maximum Age	70age old under
	Gender	Both
Health Condition or Problem Studied		Type 2 diabetes and nephropathy
Intervention(s)		investigational material(s) Generic name etc : CS-866DM INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and safety
Secondary Outcome

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-050027
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	June. 28, 2010	Detail	Changes
5	June. 28, 2010	Detail	Changes
4	April. 01, 2007	Detail	Changes
3	April. 01, 2007	Detail	Changes
2	Sept. 05, 2005	Detail	Changes
1	Sept. 05, 2005	Detail

List of change history