UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011274
Receipt No. R000013213
Scientific Title The Cardiac Insufficiency BIsoprolol Study in Japanese Patients with Chronic Heart Failure
Date of disclosure of the study information 2013/07/25
Last modified on 2017/01/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Cardiac Insufficiency BIsoprolol Study in Japanese Patients with Chronic Heart Failure
Acronym CIBIS-J
Scientific Title The Cardiac Insufficiency BIsoprolol Study in Japanese Patients with Chronic Heart Failure
Scientific Title:Acronym CIBIS-J
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the non-inferiority of bisoprolol to carvedilol by evaluating tolerability (The probability that administered maintenance dose reaches the maximum will be determined as an indicator) as a primary endpoint when bisoprolol or carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In addition, the safety and efficacy of bisoprolol will be investigated.
Basic objectives2 Others
Basic objectives -Others Tolerability (The probability that administered maintenance dose reaches the maximum will be determined as an indicator)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tolerability: The probability that administered maintenance dose reaches the maximum
(bisoprolol 5 mg/day, carvedilol 20 mg/day)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bisoprolol group
Daily oral administration of bisoprolol 0.625 mg tablet once a day should be given (Step 1). If tolerability is confirmed by an investigator, the dose should be increased to 1.25 mg (bisoprolol 0.625 mg, 2 tablets; or bisoprolol 2.5 mg, half tablet; once daily) (Step 2). In the same manner, the doses should be increased to 2.5 mg (bisoprolol 2.5 mg, 1 tablet; or bisoprolol 5 mg, half tablet; once daily, Step 3), to 3.75 mg (bisoprolol 2.5 mg, 1.5 tablets once daily, Step 4), and to 5 mg (bisoprolol 2.5 mg, 2 tablets; or bisoprolol 5 mg, 1 tablet; once daily, Step 5).
Interventions/Control_2 Carvedilol group
Daily oral administration of carvedilol 1.25 mg, 1 tablet twice a day (after breakfast and supper) should be given (Step 1). If tolerability is confirmed by an investigator after administering 2.5 mg/day of carvedilol, the dose should be increased to 5 mg (xcarvedilol 2.5 mg, 1 tablet twice daily) (Step 2). In the same manner, the dose should be increased to 10 mg (carvedilol 2.5 mg, 2 tablets twice daily, Step 3), to 15 mg (carvedilol 2.5 mg, 3 tablets twice daily, Step 4), and to 20 mg (carvedilol 10 mg, 1 tablet twice daily, Step 5).
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 As a result of diagnosis and tests before registration, a patient who is considered by an investigator to meet all requirements and to have ability to consent can be enrolled.
(1) Primary disease: In principle, ischemic heart disease or dilated cardiomyopathy.
(2) Heart failure patients with 40% or less of left ventricular ejection fraction (LVEF).
(3) Patients in NYHA functional classification Class II, III, or IV (including a medical history).
(4) Basic treatment: In principle, patients undergoing treatment with an ACE inhibitor (or angiotensin receptor blocker (ARB)), a diuretic, a digitalis preparation, etc.
(5) Patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date.
(6) Age: Patients aged 20 to less than 85 on the day of obtaining written informed consent.
(7) Hospitalized/outpatient: Either hospitalized or outpatient status.
(8) Gender: Male or Female
Key exclusion criteria Patients who meet any of the following exclusion criteria at the time of registration will be excluded:
(1) Patients who are considered not to be candidates for administration of bisoprolol or carvedilol.
(2) Patients who have developed acute myocardial infarction within 8 weeks before the registration day.
(3) Patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day.
(4) Patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day.
(5) Patients who are scheduled to undergo coronary revascularization (CABG, PCI) during the study period.
(6) Patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study.
(7) Patients from whom written informed consent cannot be obtained.
(8) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size 220

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Kita 15 Nishi 7, Kita-ku, Sapporo
TEL 011-706-6974
Email htsutsui@med.hokudai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Makoto Arai
Organization Mebix, Inc.
Division name CIBIS-J Research Operations Office
Zip code
Address 1-11-44 Akasaka, Minato-ku, Tokyo
TEL 03-6229-8936
Homepage URL
Email cibis-j@mebix.co.jp

Sponsor
Institute CIBIS-J study group
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 25 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
2013 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2015 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 29 Day
Date trial data considered complete
2016 Year 05 Month 30 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 25 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.