UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of combination tablet of angiotensin receptor blocker and high dose calcium channel blocker in essential hypertension
Title of the study (Brief title)	Efficacy of combination tablet of ARB and high dose CCB in essential hypertension
Region	Japan

Condition
Condition	patients with essential hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of combination therapy of regular dose ARB and 5 mg of amlodipine and combination tablet of regular dose ARB and 10 mg of amlodipine in patients with essential hypertension
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	blood pressure reduction
Key secondary outcomes	Changes in - endothelial function(FMD), atherosclerosis (CAVI) - urinary protein and albumin and eGFR - uric acid - plasma renin activity, aldosterone, prorenin, and soluble (pro)renin receptor

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	Combination therapy of regular dose ARB and 5 mg of amlodipine is changed to therapy with combination tablet of regular dose ARB and 10 mg of amlodipine.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- patients with essential hypertension - poor blood pressure control under combination therapy of regular dose ARB and 5 mg of amlodipine
Key exclusion criteria	pregnant women or women who are possibly pregnant
Target sample size	30

Research contact person
Name of lead principal investigator	Atsuhiro Ichihara
Organization	Tokyo Women's Medical University
Division name	Department of Medicine II
Address	8-1 Kawada-cyo, Shinjyuku-ku, Tokyo
TEL	03-3353-8111
Email	atzichi@endm.twmu.ac.jp

Public contact
Name of contact person	Satoshi Morimoto
Organization	Tokyo Women's Medical University
Division name	Department of Medicine II
Address	8-1 Kawada-cyo, Shinjyuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	smorimoto@endm.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
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	東京女子医科大学

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 04 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 01 Month 17 Day
Anticipated trial start date	2014 Year 01 Month 17 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
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	2015 Year 03 Month 04 Day
Last modified on	2017 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019375