UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011274 |
|---|---|
| Receipt number | 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 16:42:19 |
* 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
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
htsutsui@med.hokudai.ac.jp
Public contact
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
cibis-j@mebix.co.jp
Sponsor or person
Institute
CIBIS-J study group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
