UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008079 |
|---|---|
| Receipt number | R000009515 |
| Scientific Title | The safety and efficacy of Bisoprolol in patient with ischemic heart disease complicating chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2020/02/16 06:40:10 |
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Basic information
Public title
The safety and efficacy of Bisoprolol in patient with ischemic heart disease complicating chronic obstructive pulmonary disease
Acronym
The safety and efficacy of Bisoprolol in COPD patient
Scientific Title
The safety and efficacy of Bisoprolol in patient with ischemic heart disease complicating chronic obstructive pulmonary disease
Scientific Title:Acronym
The safety and efficacy of Bisoprolol in COPD patient
Region
| Japan |
Condition
Condition
The patient with ischemic heart disease complicating chronic obstructive pulmonary disease
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of Bisoprolol in patient with ischemic heart disease complicating chronic obstructive pulmonary disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Respiratory function after 9 months intervention
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
Bisoprolol, maintenance dose of 5mg/day (allowed to be started with 0.625mg/day according to the condition of the patient), for 9 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The ischemic heart disease patient with chronic obstructive respiratory disease (COPD) defined in COPD clinical guideline of Japanese Respiratory Society
Key exclusion criteria
The patient with contraindication of Bisoprolol.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Furuse |
Organization
Tottori University
Division name
Faculty of Medicine, Department of Molecular Medicine and Therapeutics
Zip code
6838504
Address
36-1 Nishimachi, Yonago, 683-8504, Japan
TEL
0859-38-6517
yfuruse-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Furuse |
Organization
Tottori University
Division name
Faculty of Medicine, Department of Molecular Medicine and Therapeutics
Zip code
6838504
Address
36-1 Nishimachi, Yonago, 683-8504, Japan
TEL
0859-38-6517
Homepage URL
yfuruse-circ@umin.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine, Department of Molecular Medicine and Therapeutics
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
Faculty of Medicine, Department of Molecular Medicine and Therapeutics, Tottori University
Address
36-1 Nishimachi, Yonago, 683-8504, Japan
Tel
0859-38-6517
yfuruse-circ@umin.ac.jp
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
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.umin.ac.jp/ctr/index.htm
Publication of results
Unpublished
Result
URL related to results and publications
https://www.umin.ac.jp/ctr/index.htm
Number of participants that the trial has enrolled
50
Results
The trial was closed due to lack of applicants.
Results date posted
| 2020 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The trial was closed due to lack of applicants.
Participant flow
The trial was closed due to lack of applicants.
Adverse events
The trial was closed due to lack of applicants.
Outcome measures
The trial was closed due to lack of applicants.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2020 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009515
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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