UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016023 |
|---|---|
| Receipt number | R000018586 |
| Scientific Title | The efficacy and safety of a bisoprolol transdermal patch in patients with cerebral hemorrhage |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2017/12/25 11:36:06 |
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Basic information
Public title
The efficacy and safety of a bisoprolol transdermal patch in patients with cerebral hemorrhage
Acronym
The efficacy and safety of a bisoprolol transdermal patch in patients with cerebral hemorrhage
Scientific Title
The efficacy and safety of a bisoprolol transdermal patch in patients with cerebral hemorrhage
Scientific Title:Acronym
The efficacy and safety of a bisoprolol transdermal patch in patients with cerebral hemorrhage
Region
| Japan |
Condition
Condition
cerebral hemorrhage
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the heart rate of patients of cerebral hemorrhage with or without bisoprolol
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
heart rate
Key secondary outcomes
dose of nicardipine
withdrawal of bisoprolol and nicardipine
neurological prognosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
monotherapy group:constant infusion of nicardipine
Interventions/Control_2
combination group: bisoprolol transdermal patch(8mg) + constant infusion of nicardipine
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients with cerebral hemorrhage detected by X-ray CT scan
2.patients which need the depressor therapy
3.both new-onset or recurrent cerebral hemorrhage are permitted
4.having prehospital oral medicine or not does not matter
5.no criteria of age
Key exclusion criteria
1.patients of an immediate operation is needed
2.patients with a severe bradycardia or tachycardia
3.patients with atrioventricular block(second-degree or third-degree) or sinoatrial block or sick sinus syndrome
4.patients with severe peripheral circulation disturbance
5.patients with untreated pheochromocytoma
6.pregnant or possibly pregnant
7.patients with a history allergy against nicardipine or bisoprolol
8.patients who are judged inappropriate for the study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Momoo |
Organization
Hiratsuka Kyosai Hospital
Division name
Department of Neurology
Zip code
Address
9-11 Oiwake, Hiratsuka, Kanagawa 254-8502, Japan
TEL
0463-32-1950
momoo-t@kkr.hiratsuka.kanagawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoo Yamamoto |
Organization
Hiratsuka Kyosai Hospital
Division name
Department of Neurology
Zip code
Address
9-11 Oiwake, Hiratsuka, Kanagawa 254-8502, Japan
TEL
0463-32-1950
Homepage URL
ryamamoto-tuk@umin.ac.jp
Sponsor or person
Institute
Hiratsuka Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
平塚共済病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018586
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
