UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014323 |
|---|---|
| Receipt number | R000016676 |
| Scientific Title | A randomized clinical trial to evaluate the efficacy of catecholamine surge supression by oral azilsartan in patients with hypertensive intracerebral hemorrhage |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2016/12/21 09:29:40 |
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Basic information
Public title
A randomized clinical trial to evaluate the efficacy of catecholamine surge supression by oral azilsartan in patients with hypertensive intracerebral hemorrhage
Acronym
A randomized trial to evaluate the efficacy of catecholamine surge supression by azilsartan in patients with hypertensive ICH
Scientific Title
A randomized clinical trial to evaluate the efficacy of catecholamine surge supression by oral azilsartan in patients with hypertensive intracerebral hemorrhage
Scientific Title:Acronym
A randomized trial to evaluate the efficacy of catecholamine surge supression by azilsartan in patients with hypertensive ICH
Region
| Japan |
Condition
Condition
Hypertensive intracerebral hemorrhage
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efiicacy of azilsartan to suppress catecholamine surge in patients with hypertensive ICH.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Chronological change in plasma levels of catecholamines, renin, and aldosterone
Key secondary outcomes
Chronological changes in systemic blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test arm: azilsartan administration
Interventions/Control_2
Control arm: candesartan administration
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20-85 years of age
Hypertensive ICH within 6h of onset
No disturbance of consciousness
Those who gave us consent
Key exclusion criteria
Non-hypertensive ICH
Those with disturbance of consciousness
Those who did not give us consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Inamasu |
Organization
Fujita Health University
Division name
Neurosurgery
Zip code
Address
1-98 Dengakugakubo, Toyoake
TEL
0562-93-9253
inamasu@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joji Inamasu |
Organization
Fujita Health University
Division name
Neurosurgery
Zip code
Address
1-98 Dengakugakubo, Toyoake
TEL
0562-93-9253
Homepage URL
inamasu@fujita-hu.ac.jp
Sponsor or person
Institute
Clinical Research Institute, Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Institute, Fujita Health University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinical Research Institute, Fujita Health University Hospital
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
藤田保健衛生大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 20 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016676
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
