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	jRCT1080220028

Scientific Title	Calblock tablet postmarketing clinical study (Essential hypertensive patients with type 2 diabetes)
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	Randomized open study
Study Design	Objective
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	Inclusion criteria: -Patient, age 30-79 -Blood pressure: stable, mean SBP >= 140 and <180 mmHg, and mean DBP >= 90 and <110 mmHg.
	Exclusion Criteria	Exclusion criteria: -Secondary hypertension or malignant hypertension -Cerebrovascular disease and cardiovascular disease -Patient with poor glycemic control
	Minimum Age	30age old over
	Maximum Age	79age old under
	Gender	Both
Health Condition or Problem Studied		Mild-to-moderate essential hypertension with type 2 diabetes
Intervention(s)		investigational material(s) Generic name etc : Calblock tablet(Azelnidipine)\|Acecol tablet(Temocapril Hydrochloride) INN of investigational material : azelnidipine/Temocapril 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
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-050028
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
10	Dec. 17, 2018	(this page)	Changes
9	June. 28, 2010	Detail	Changes
8	June. 28, 2010	Detail	Changes
7	Jan. 09, 2009	Detail	Changes
6	Dec. 26, 2008	Detail	Changes
5	Dec. 26, 2008	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