UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study
Title of the study (Brief title)	COMPATIBLE extension RAS study
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the presence of aldosterone breakthrough or not after long term treatment with olmesartan. We found decreased aldosterone concentration after 3 months and 6 months treatment with olmesartan in COMPATIBLE study, but no available data presents for aldosterone concentration after long term treatment with ARBs over years. The change of aldosterone with long term treatment of ARB may add novel point of view in hypertension treatment.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Aldosterone concentration
Key secondary outcomes	Renin Angiotensin I Angiotensin II Urinary albumin-to-creatinine ratio

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of Olmesartan
Interventions/Control_2
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who were participants in the prior COMPATIBLE Study, and still takes Olmesartan at the same attended clinic.
Key exclusion criteria	The patient who do not take Olmesartan.
Target sample size	100

Research contact person
Name of lead principal investigator	Hisao Mori
Organization	Kanagawa Association of Medical and Dental Practitioners
Division name	Department of Clinical Research
Address	TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan
TEL	045-313-2111
Email	hmori@gem.hi-ho.ne.jp

Public contact
Name of contact person	Hisao Mori
Organization	Kanagawa Association of Medical and Dental Practitioners
Division name	Department of Clinical Research
Address	TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan
TEL	045-313-2111
Homepage URL
Email	hmori@gem.hi-ho.ne.jp

Sponsor
Institute	Kanagawa Association of Medical and Dental Practitioners
Institute
Department

Funding Source
Organization	DAIICHI SANKYO CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 24 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
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	2014 Year 10 Month 02 Day
Last modified on	2018 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017807