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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014323
Receipt No. 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

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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
Email 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
Email inamasu@fujita-hu.ac.jp

Sponsor
Institute Clinical Research Institute, Fujita Health University Hospital
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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