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
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
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
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
