UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032276 |
|---|---|
| Receipt number | R000036805 |
| Scientific Title | The differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate in patients with hypertension and heart failure |
| Date of disclosure of the study information | 2018/04/20 |
| Last modified on | 2018/10/16 15:25:49 |
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Basic information
Public title
The differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate in patients with hypertension and heart failure
Acronym
The differences between oral bisoprolol and bisoprolol patch
Scientific Title
The differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate in patients with hypertension and heart failure
Scientific Title:Acronym
The differences between oral bisoprolol and bisoprolol patch
Region
| Japan |
Condition
Condition
Hypertensive patients complicated with heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood pressures and pulse rates variability
Key secondary outcomes
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
Hypertensive patients complicated with heart failure who are treated with oral bisoprolol are entrolled in this study.
And, we evaluate blood pressure and pulse rate variability after switching from oral bisoprolol to bisoprolol patch.
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Out patients with hypertension and heart failure of NHYA classification of I - III who are administrated with oral bisoprolol.
The dosage of oral bisoprolol does not change for 4 weeks or more.
Key exclusion criteria
Pregnancy, breast-feeding, patients who may be pregnant, and patients who want pregnancy during the study
Patients with skin disease
Patients who were judged inappropriate as subjects of this examination by investigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kiuchi |
Organization
Toho University Omori Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541
TEL
03-3762-4151
syunnsuke@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kiuchi |
Organization
Toho University Omori Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541
TEL
03-3762-4151
Homepage URL
syunnsuke@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Ce
nter, Department of Cardiovascul
ar Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 20 | 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
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036805
