UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of azilsartan on 24-h ambulatory blood pressure in patients with CKD and hypertension.
Title of the study (Brief title)	Effect of azilsartan on 24-h ambulatory blood pressure in CKD
Region	Japan

Condition
Condition	CKD and hypertension
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study was to measure the effects on blood pressure (BP) of the angiotensin receptor blocker azilsartan medoxomil.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was 24-h systolic BP by ambulatory monitoring.
Key secondary outcomes

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	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	This was a open, cross-over (azilsartan or other ARB) study of 12 weeks' duration in 20 patients with CKD and hypertension.
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

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	Inclusion criteria were following; -outpatient -a steady dose of ARB other than azilsartan -without hyperkalemia and progression of renal damage by ARB -instructed nutritional guidance -take ARBs for over 3 months -BP of >130/80 mmHg of the run-in period -ABPM was done within 6 months
Key exclusion criteria	Exclusion criteria were known hypersensitivity to ARBs, ACE inhibitors or direct renin inhibitors and pregnancy or lactation.
Target sample size	20

Research contact person
Name of lead principal investigator	Katsuomi Matsui
Organization	St. Marianna University School of Medicine
Division name	Department of Nephrology and Hypertension, Internal Medicine
Address	2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL	044-977-8111
Email	m.katsuomi@marianna-u.ac.jp

Public contact
Name of contact person	Katsuomi Matsui
Organization	St. Marianna University School of Medicine
Division name	Department of Nephrology and Hypertension, Internal Medicine
Address	2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL	044-977-8111
Homepage URL
Email	m.katsuomi@marianna-u.ac.jp

Sponsor
Institute	Nephrology and Hypertension, St. Marianna University School of Medicine
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	Nephrology and Hypertension, St. Marianna University School of Medicine
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 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 04 Day
Anticipated trial start date	2013 Year 11 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 01 Month 23 Day
Last modified on	2016 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015117