UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009469 |
|---|---|
| Receipt number | R000011122 |
| Scientific Title | Effect of ARB on Blood Pressure and Quality of Life |
| Date of disclosure of the study information | 2012/12/03 |
| Last modified on | 2015/06/03 13:59:19 |
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Basic information
Public title
Effect of ARB on Blood Pressure and Quality of Life
Acronym
APEQ
Scientific Title
Effect of ARB on Blood Pressure and Quality of Life
Scientific Title:Acronym
APEQ
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For a hypertensive patient, examine the validity and QOL of azilsultan medical treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
he amount of change of the ambulatory blood pressure at baseline and after 3 months of use
Key secondary outcomes
1) The Quantity of change of the QOL score at baseline and after 3 months of use.
2) The amount of change of a blood test value at baseline and after 3 months of use.
3) The amount of change of home blood pressure at baseline and after 3 months of use.
4) Safety which led overall treatment term/time.
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
Medical treatment which drops blood pressure is aimed at by azilsultan.
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
The patient who treated by combined use of ARB (except azilsultan) or other antihypertensive agents one month or more, and the hypertensive patient of high-blood-pressure guideline target unattainment
Key exclusion criteria
1) Secondary hypertensive patient
2) Patients with moderate or severe cardiac dysfunction (NYHA class 3 or 4)
3) Pregnant and/or expecting women
4) Patients with severe impaired liver function
5)Patients with kidney dysfunction(sCr>=2.0mg/dl)
6) Patients with a history of hypersensitivity to the azilsultan
7)Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Node |
Organization
Saga University Faculty of Medicine
Division name
Department of Cardiovascular medicine
Zip code
Address
5-1-1 Nabeshima, Saga-shi, Saga
TEL
0952-34-2364
node@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Oyama |
Organization
Study group for Hypertension medical treatment in Saga
Division name
Secretariat
Zip code
Address
5-1-1Nabeshima, Saga-shi, Saga
TEL
0952-34-2364
Homepage URL
junoyama@cc.saga-u.ac.jp
Sponsor or person
Institute
Study group for Hypertension medical treatment in Saga
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
佐賀大学医学部附属病院、池田内科皮膚科医院、ロコメディカル江口病院、伊万里有田共立病院、佐賀県医療センター好生館、唐津赤十字病院、佐賀記念病院、福田脳神経外科病院、志田病院、鶴田内科循環器科医院、矢ヶ部医院、山口クリニック、えとう内科循環器内科、諸江内科循環器科医院、ニコークリニック、貝原医院、大町町立病院、織田病院、朝長医院、河畔病院、脇山内科、岩本内科、関医院、城内病院、水上医院、石井内科、中尾胃腸科医院、南医院、うえむら病院、枝國医院、高橋内科、藤崎医院、鶴田内科（以上、すべて佐賀県）、三佼会宮崎病院（長崎）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 03 | 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
azilsultan medical treatment group, the blood pressure tends to fall.
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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2015 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011122
