UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial
Title of the study (Brief title)	Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial
Region	Japan

Condition
Condition	Essential hypertension
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of Ca channel blockers on the prorenin-soluble (pro)renin system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma levels of prorenin and soluble (pro)renin receptor
Key secondary outcomes	1, blood pressure, pulse rate 2, renal function: urinary protein/creatinine ratio, urinary albumin/creatinine ratio, eGFR, cystatin C, pentosidine 3, renin-angiotenin system: plasma renin activity, plasma renin concentration, plasma aldosterone concentration 4, sympathetic nervous system: catecholamine 5, oxidative stress marker: urine 8-OHdG 6, vascular endothelial function: flow-mediated dilation(FMD) 7, atherosclerosis: cardio-ankle vascular index(CAVI), augmentation index(AI)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is 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	Patients are treated with amlodipine.
Interventions/Control_2	Patients are treated with cilnidipine.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Essential hypertensive patients who were treated in the department of medicine II, Tokyo Women's medical university, and fulfilled following conditions were enrolled: 1, systolic blood pressure <180mmHg and diastolic blood pressure <110mmHg. 2, untreated or treated only with anti-hypertensive drugs except calcium channel blockers.
Key exclusion criteria	1,Patients with chronic kidney disease (CKD) stage 4 or greater 2,Patients with past histories of myocardial or cerebral infarction within the previous six months 3,Expectant mothers and lactating women 4,Patiens who have allergy to amlodipine or cilnidipine
Target sample size	100

Research contact person
Name of lead principal investigator	Atsuhiro Ichihara
Organization	Tokyo Women's Medical University
Division name	Department of hypertension and endocrinology
Address	8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL	03-3353-8111
Email	dwatanabe@endm.twmu.ac.jp

Public contact
Name of contact person	Daisuke Watanabe
Organization	Tokyo Women's Medical University
Division name	Department of hypertension and endocrinology
Address	8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	dwatanabe@endm.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2015 Year 01 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 07 Month 05 Day
Anticipated trial start date	2015 Year 01 Month 05 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	2015 Year 01 Month 05 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018727