UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Increasing Dose of Calcium Channel Blockers for Insufficiently Controlled Hypertension
Title of the study (Brief title)	AIMIX study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate effects of AIMIX on blood pressure and Hba1c
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Home blood pressure
Key secondary outcomes	Hba1c, Urine albumin

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	AIMIX
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 hypertension that are insufficiently treated with medication of ARBs and calcium channel blockers
Key exclusion criteria	Patients with insufficient treatment on diabetes mellitus Pregnant women Patients that are recognized as inappropriate for this study
Target sample size	100

Research contact person
Name of lead principal investigator	Shinya Minatoguchi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology
Address	1-1 Yanagido, Gifu
TEL	058-230-6523
Email	minatos@gifu-u.ac.jp

Public contact
Name of contact person	Shinya Minatoguchi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology
Address	1-1 Yanagido, Gifu
TEL	058-230-6523
Homepage URL
Email	minatos@gifu-u.ac.jp

Sponsor
Institute	Department of Cardiology, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2013 Year 11 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 08 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry	2016 Year 05 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	2013 Year 11 Month 07 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=R000014265