UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Cilnidipine on plasma aldosterone: influence of autonomic function
Title of the study (Brief title)	Cilnidipine suppression of aldosterone and autonomic function
Region	Japan

Condition
Condition	Hypertensive patients
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the influence of autonomic function on the effects of Cilnidipine on plasma aldosterone in hypertensive patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in plasma renin activity and aldosterone concentration
Key secondary outcomes	Changes in value of the following data (Blood Pressure, cardiac mass, IMT, PWV and urinary albumin 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	Cilnidipine 5-20mg/day
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	1) Patients who were assessed autonomic nervous function 2) Patients with essential hypertension 3) Patients who take Ca channel blocker, except for Cilnidipine 4) Patients who agreed to participate with written informed consent
Key exclusion criteria	1) Patients with age of 20 years or less 2) Patients with contraindication to Cilnidipine 3) Patients who are judged to be inappropriate to participate by the physicians
Target sample size	40

Research contact person
Name of lead principal investigator	Yuji, Moriwaki
Organization	Hyogo college of medicine
Division name	Division of Endocrinology and Metabolism, Department of Internal Medicine
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6473
Email	mkurajoh@gmail.com

Public contact
Name of contact person	Kurajoh, Masafumi
Organization	Hyogo college of medicine
Division name	Division of Endocrinology and Metabolism, Department of Internal Medicine
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6472
Homepage URL
Email	mkurajoh@gmail.com

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 02 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	2013 Year 07 Month 01 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012982