臨床研究等提出・公開システム

Date of registration	June. 10, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080221127

Scientific Title	An Open Label, Non-comparative Observational Study to Evaluate the Efficacy and Safety of Olmesartan Medoxomil Tablet 20mg in the Treatment of Mild to Moderate Essential Hypertension for 24 Weeks in Chinese Patients & a Sub-group of ABPM Study to Measure the T/P Ratio and Ambulatory Blood Pressure Change
Public Title	EXPO

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		300
Study Type		Interventional
Study Design	Study Design	multi-center, open label, single arm, non-comparative study
Study Design	Objective
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	90<=SeDBP<110mmHg, SeSBP<180mmHg
	Exclusion Criteria	None
	Minimum Age	18age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Mild to moderate essential hypertension
Intervention(s)		investigational material(s) Generic name etc : Olmesartan Medoxomil INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : 20mg once daily, and up titrate to 40mg/d when necessary control material(s) Generic name etc : None INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : None
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		SeDBP, SeSBP, ABPM and Home BP SeDBP and SeSBP changes from baseline at week 4,8,12,16,20,24 after treatment
Secondary Outcome		SeDBP, SeSBP, ABPM and Home BP Target rate of SeSBP and SeDBP at each visit respectively Response rate of SeSBP and SeDBP

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

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

Secondary ID No.	JapicCTI-101162
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Jan. 21, 2013	Detail	Changes
5	Jan. 21, 2013	Detail	Changes
4	Jan. 18, 2013	Detail	Changes
3	Jan. 18, 2013	Detail	Changes
2	June. 10, 2010	Detail	Changes
1	June. 10, 2010	Detail

List of change history