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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008079
Receipt No. 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

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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
Email 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
Email yfuruse-circ@umin.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine, Department of Molecular Medicine and Therapeutics
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009515

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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