臨床研究等提出・公開システム

Date of registration	July. 06, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221505

Scientific Title	A Phase 3 study of S-474474 in patients with essential hypertension
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	Shionogi & Co., Ltd.
	Address	http://www.shionogi.co.jp/information/inquiry_entrance.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, parallel -group comparative study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with essential hypertension who meet the following criteria: Seated systolic blood pressure is >=150 mmHg and <200 mmHg, and diastolic blood pressure >=95 mmHg and <115 mmHg, etc.
	Exclusion Criteria	Patients with renal, hepatic or heart disease
	Minimum Age	20age old over
	Maximum Age	79age old under
	Gender	Both
Health Condition or Problem Studied		Hypertension
Intervention(s)		investigational material(s) Generic name etc : S-474474 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		Change in trough seated diastolic blood pressure
Secondary Outcome		Change in trough seated systolic pressure, normalization rate, the incidents of adverse events and adverse drug reactions, etc

Primary Sponsor	SHIONOGI & 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-111544
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 28, 2015	Detail	Changes
7	Dec. 28, 2015	Detail	Changes
6	Oct. 15, 2013	Detail	Changes
5	Oct. 09, 2013	Detail	Changes
4	Aug. 01, 2012	Detail	Changes
3	Aug. 01, 2012	Detail	Changes
2	July. 06, 2011	Detail	Changes
1	July. 06, 2011	Detail

List of change history