UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of Azilsartan or Olmesartan on renin-angiotensin-aldosterone system.
Title of the study (Brief title)	Influence of Azilsartan or Olmesartan on renin-angiotensin-aldosterone system.
Region	Japan

Condition
Condition	essential hypertension
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reserch the effects of administration of Azilsartan or Olmesartan in influence for renin-angiotensin-aldosterone system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	renin, angiotensin, aldosterone
Key secondary outcomes	UCG (LVMI, EF) BNP cystatin C, albuminuria, Ox-LDL Blood pressure, heart rate Cr, eGFR ABI, PWV side effect

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switch from Azilsartan to Olmesartan
Interventions/Control_2	Switch from Olmesartan to Azilsartan
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who is taking Olmesartan for hypertension Patients from whom informed consent was obtained
Key exclusion criteria	Patients from whom informed consent was not obtained
Target sample size	60

Research contact person
Name of lead principal investigator	Akira Sezai
Organization	Nihon University school of medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	Hisakuni Sekino
Organization	Sekino Hospital
Division name	clinical research ethics committee
Address	3-28-3 Ikebukuro, Toshima-ku, Tokyo
TEL	090539846038
Homepage URL
Email	asezai.med@gmail.com

Sponsor
Institute	Sekino Hospital, Nihon Univ. Itabashi Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	関野病院、日大板橋病院

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 01 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 19 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012879