臨床研究等提出・公開システム

Date of registration	July. 29, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220002

Scientific Title	Olmesartan Mega study to determine the relationship between Cardiovascular Endpoints and Blood pressure Goal Achievement
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		Observational
Study Design	Study Design	Single Group Cohort
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Essential hypertension, outpatient, consenting patient, age 50-79.
	Exclusion Criteria	A history of myocardial infarction, stroke, coronary artery bypass graft surgery, and percutaneous coronary intervention within 6 months before the registration.A scheduled coronary intervention at registration. A diagnosis congenital or rheumatic heart disease, severe arrhythmia, liver or renal disease, and current diagnosis of malignancy.
	Minimum Age	50age old over
	Maximum Age	79age old under
	Gender	Both
Health Condition or Problem Studied		Essential hypertension
Intervention(s)		investigational material(s) Generic name etc : Olmetec(Olmesartan Medoxomil) 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		Development of stroke,myocardial infarction, unstable angina required hospitalization,and sudden and unexpected death.
Secondary Outcome

Primary Sponsor	DAIICHI SANKYO COMPANY, LIMITED
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	None
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-050002
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Aug. 06, 2015	Detail	Changes
9	Mar. 29, 2011	Detail	Changes
8	Mar. 29, 2011	Detail	Changes
7	June. 10, 2010	Detail	Changes
6	June. 02, 2010	Detail	Changes
5	April. 01, 2007	Detail	Changes
4	April. 01, 2007	Detail	Changes
3	Aug. 12, 2005	Detail	Changes
2	July. 29, 2005	Detail	Changes
1	July. 29, 2005	Detail

List of change history