UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003684 |
|---|---|
| Receipt number | R000004369 |
| Scientific Title | A comparison of twenty-four-hour blood pressure control between candesartan and other ARBs estimated by the ambulatory blood pressure monitoring |
| Date of disclosure of the study information | 2010/06/19 |
| Last modified on | 2019/12/09 17:57:37 |
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Basic information
Public title
A comparison of twenty-four-hour blood pressure control between candesartan and other ARBs estimated by the ambulatory blood pressure monitoring
Acronym
Effect of candesartan on 24-hours blood pressure control
Scientific Title
A comparison of twenty-four-hour blood pressure control between candesartan and other ARBs estimated by the ambulatory blood pressure monitoring
Scientific Title:Acronym
Effect of candesartan on 24-hours blood pressure control
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of 24-hour blood pressure control between candesartan and other angiotensin 2 receptor blockers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The difference of mean nocturnal blood pressure between candesartan and other angiotensin 2 receptor blockers.
Key secondary outcomes
The difference of mean 24-hour blood pressure between candesartan and other angiotensin 2 receptor blockers.
The difference of mean morning blood pressure between candesartan and other angiotensin 2 receptor blockers.
Percentage of the patient who achieved the target of 24-hour blood pressure in Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2009).
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
Change ARB(except for candesartan) to candesartan.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with hypertension who are treated with ARB other than candesartan. Their blood pressure levels evaluated by ABPM do not achieve the goal of Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2009).
Key exclusion criteria
1. secondary hypertension
2. systolic blood pressure >160 mmHg and or diastolic blood pressure > 100 mmHg
3. malignant hypertension
4. history of stroke, myocardial infarction and other cardiovascular disease that needed hospitalization within recent 6 months.
5. atrial fibrillation
6. patients with fundal hemorrhage, exudation or papilledema due to hypertensive retinopathy
7. liver dysfunction(the levels of AST or ALT reached 250% of their upper normal limit.)
8. Renal dysfunction (serum creatinine >
2.0 mg/dl)
9. hyperkalemia (serum K > 5.5 mEq/l)
10. pregnant or nursing women
11. patients who are not recommended for participation in this study by physician in charge with medical reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Higaki Jitsuo |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Integrated Medicine and Informatics
Zip code
Address
Shitsukawa Toon Ehime 791-0295 Japan
TEL
089-960-5302
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okura Takafumi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Integrated Medicine and Informatics
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295 Japan
TEL
089-960-5302
Homepage URL
okura@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Integrated Medicine, Ehime University Graduate Schoolof Medicine
Institute
Department
Personal name
Funding Source
Organization
Ehime University
Organization
Division
Category of Funding Organization
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
愛媛大学医学部附属病院(愛媛県），済生会松山病院(愛媛県），松山赤十字病院(愛媛県），医療法人滴水会吉野病院(愛媛県），かとうクリニック(愛媛県），菅病院(愛媛県），鬼北町立北宇和病院(愛媛県）
愛媛県東温市志津川
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 19 | 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
| 2010 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2010 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 09 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004369
