UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012931
Receipt number R000015117
Scientific Title Effect of azilsartan on 24-h ambulatory blood pressure in patients with CKD and hypertension.
Date of disclosure of the study information 2015/02/01
Last modified on 2016/07/26 12:49:39

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Basic information

Public title

Effect of azilsartan on 24-h ambulatory blood pressure in patients with CKD and hypertension.

Acronym

Effect of azilsartan on 24-h ambulatory blood pressure in CKD

Scientific Title

Effect of azilsartan on 24-h ambulatory blood pressure in patients with CKD and hypertension.

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Katsuomi Matsui

Organization

St. Marianna University School of Medicine

Division name

Department of Nephrology and Hypertension, Internal Medicine

Zip code


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

1st name
Middle name
Last name Katsuomi Matsui

Organization

St. Marianna University School of Medicine

Division name

Department of Nephrology and Hypertension, Internal Medicine

Zip code


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 or person

Institute

Nephrology and Hypertension, St. Marianna University School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2013 Year 10 Month 04 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015117


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name