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The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bisoprolol
Carvedilol
Sponsored by
Mebix Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 (Coronary artery bypass grafting; CABG, Percutaneous coronary intervention; 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.

Sites / Locations

  • Banbuntane Hotokukai HospitalRecruiting
  • Chukyo HospitalRecruiting
  • Nagoya City University HospitalRecruiting
  • Takezawa ClinicRecruiting
  • Hirosaki University School of Medicine & HospitalRecruiting
  • Ehime Prefectural Central HospitalRecruiting
  • Saiseikai Matsuyama HospitalRecruiting
  • Ehime University HospitalRecruiting
  • University of Fukui HospitalRecruiting
  • Chiyo ClinicRecruiting
  • Kitakyushu Municipal Yahata HospitalRecruiting
  • Takagi HospitalRecruiting
  • Kizawa memorial hospitalRecruiting
  • Gunma University HospitalRecruiting
  • Gunmaken Saiseikai Maebashi HospitalRecruiting
  • Maebashi Red Cross HospitalRecruiting
  • Ota Memorial HospitalRecruiting
  • National Hospital Organization Kure Medical CenterRecruiting
  • Shobara Red Cross HospitalRecruiting
  • Hokkaido P.W.F.A.C Asahikawa-Kosei General HospitalRecruiting
  • Kihara cardiovascular clinicRecruiting
  • Ebetsu City HospitalRecruiting
  • Hokkaido Chuo Rosai HospitalRecruiting
  • Otaru Kyokai HospitalRecruiting
  • Hokkaido Medical CenterRecruiting
  • JR Sapporo HospitalRecruiting
  • KKR Sapporo Medical CenterRecruiting
  • Sapporo City General HospitalRecruiting
  • Sapporo Medical Center NTT EastRecruiting
  • Sapporo Medical University HospitalRecruiting
  • Sunagawa City Medical CenterRecruiting
  • Hyogo Brain and Heart CenterRecruiting
  • Kobe University HospitalRecruiting
  • Hyogo College Of MedicineRecruiting
  • Nishiwaki Municipal HospitalRecruiting
  • Hitachi General HospitalRecruiting
  • Kanazawa Cardiovascular HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Kagawa UniversityRecruiting
  • St. Marianna University School of MedicineRecruiting
  • Kitasato University HospitalRecruiting
  • Nishi Yokohama HospitalRecruiting
  • Yokohamashintoshi Neurosurgical HospitalRecruiting
  • Kochi Medical School HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Nagasaki Goto Chuoh HospitalRecruiting
  • Nara Hospital Kinki University Faculty of MedicineRecruiting
  • Nara Prefecture Western Medical CenterRecruiting
  • Nara Medical UniversityRecruiting
  • Tsunan Metropolitan HospitalRecruiting
  • Ohama Daiichi HospitalRecruiting
  • Urasoe General HospitalRecruiting
  • Osaka National HospitalRecruiting
  • Nozaki Tokushukai HospitalRecruiting
  • Kansai Medical University Hirakata HospitalRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • Osaka University HospitalRecruiting
  • Yayoigaoka Kage HospitalRecruiting
  • Saitama Medical University International Medical CenterRecruiting
  • Ikebukuro HospitalRecruiting
  • Kusatsu General HospitalRecruiting
  • Hamamatsu University HospitalRecruiting
  • Juntendo Shizuoka HospitalRecruiting
  • Dokkyo Medical UniversityRecruiting
  • Ohta ClinicRecruiting
  • Nishiarai Heart Center HospitalRecruiting
  • Juntendo University HospitalRecruiting
  • Medical Hospital of Tokyo Medical and Dental UniversityRecruiting
  • Tokyo Metropolitan Tama Medical CenterRecruiting
  • Minamino Heart ClinicRecruiting
  • Hino Municipal HospitalRecruiting
  • Tokyo Medical CenterRecruiting
  • 100Recruiting
  • Daisankitashinagawa hospitalRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Tottori University HospitalRecruiting
  • Yamaguchi Grand Medical CenterRecruiting
  • Shimonoseki City HospitalRecruiting
  • Yamaguchi University HospitalRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Akita University HospitalRecruiting
  • Hakujyuji HospitalRecruiting
  • Haradoi HospitalRecruiting
  • Kyushu University HospitalRecruiting
  • Saiseikai Fukuoka General HospitalRecruiting
  • Fukushima Daiichi HospitalRecruiting
  • Ohara General HospitalRecruiting
  • Gifu University HospitalRecruiting
  • Hiroshima General Hospital of West Japan Railway CompanyRecruiting
  • Hiroshima University HospitalRecruiting
  • Tenyoukai Central HospitalRecruiting
  • Kumamoto University HospitalRecruiting
  • Kyoto University HospitalRecruiting
  • Takenaka ClinicRecruiting
  • Ebisu-hospitalRecruiting
  • Medical Inc. Kosei-kai Nijigaoka HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • Nara City HospitalRecruiting
  • Nara Prefecture General Medical CenterRecruiting
  • Kuwana hospitalRecruiting
  • Niigata University Medical & Dental HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Graduate School of Medicine and Faculty of MedicineRecruiting
  • JCHO Osaka HospitalRecruiting
  • Kitano HospitalRecruiting
  • Sakurabashi Watanabe HospitalRecruiting
  • Saitama Medical Center Jichi Medical UniversityRecruiting
  • Tokushima University HospitalRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Kanoiwa General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bisoprolol group

Carvedilol group

Arm Description

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).

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 (carvedilol 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy: New York Heart Association (NYHA) Functional Classification
Efficacy: Left Ventricular Ejection Fraction (LVEF)
Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)
Efficacy: Heart rate
Efficacy: Plasma brain natriuretic peptide (BNP)
Safety: All deaths
Safety: Deaths with cardiovascular causes
Safety: Hospitalization for cardiovascular causes
Safety: Exacerbation of heart failure, resulting in hospitalization, and/or intensification of treatment (increase in dose of any diuretics, vasodilators or cardiotonics, in comparison with the dose-setting period), or administration of new drugs.
Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure)
Safety: Sudden deaths, including deaths due to arrhythmia
Safety: Deaths with non-cardiovascular causes
Safety: Adverse events
Safety: Changes in clinical laboratory test results

Full Information

First Posted
May 1, 2014
Last Updated
May 10, 2014
Sponsor
Mebix Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02137733
Brief Title
The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
Official Title
The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mebix Inc

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bisoprolol group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Carvedilol group
Arm Type
Active Comparator
Arm Description
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 (carvedilol 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).
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Primary Outcome Measure Information:
Title
Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Efficacy: New York Heart Association (NYHA) Functional Classification
Time Frame
24 and 48 weeks
Title
Efficacy: Left Ventricular Ejection Fraction (LVEF)
Time Frame
24 and 48 weeks
Title
Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)
Time Frame
24 and 48 weeks
Title
Efficacy: Heart rate
Time Frame
24 and 48 weeks
Title
Efficacy: Plasma brain natriuretic peptide (BNP)
Time Frame
24 and 48 weeks
Title
Safety: All deaths
Time Frame
48 weeks
Title
Safety: Deaths with cardiovascular causes
Time Frame
48 weeks
Title
Safety: Hospitalization for cardiovascular causes
Time Frame
48 weeks
Title
Safety: Exacerbation of heart failure, resulting in hospitalization, and/or intensification of treatment (increase in dose of any diuretics, vasodilators or cardiotonics, in comparison with the dose-setting period), or administration of new drugs.
Time Frame
48 weeks
Title
Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure)
Time Frame
48 weeks
Title
Safety: Sudden deaths, including deaths due to arrhythmia
Time Frame
48 weeks
Title
Safety: Deaths with non-cardiovascular causes
Time Frame
48 weeks
Title
Safety: Adverse events
Time Frame
48 weeks
Title
Safety: Changes in clinical laboratory test results
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Primary disease: In principle, ischemic heart disease or dilated cardiomyopathy. Heart failure patients with 40% or less of left ventricular ejection fraction (LVEF) . Patients in NYHA functional classification Class II, III, or IV (including a medical history). Basic treatment: In principle, patients undergoing treatment with an ACE inhibitor (or angiotensin receptor blocker (ARB)), a diuretic, a digitalis preparation, etc. Patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date. Age: Patients aged 20 to less than 85 on the day of obtaining written informed consent. Hospitalized/outpatient: Either hospitalized or outpatient status. Gender: Male or Female Exclusion Criteria: Patients who meet any of the following exclusion criteria at the time of registration will be excluded: Patients who are considered not to be candidates for administration of bisoprolol or carvedilol. Patients who have developed acute myocardial infarction within 8 weeks before the registration day. Patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day. Patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day. Patients who are scheduled to undergo coronary revascularization (Coronary artery bypass grafting; CABG, Percutaneous coronary intervention; PCI) during the study period. Patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study. Patients from whom written informed consent cannot be obtained. Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Yamada
Phone
03-6229-8936
Email
Cibis-j@mebix.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Tsutsui
Organizational Affiliation
Hokkaido University Graduate School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Banbuntane Hotokukai Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Izawa
Phone
052-321-8171
Facility Name
Chukyo Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoya Tsuboi
Phone
052-691-7151
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidekatsu Fukuda
Phone
052-851-5511
Facility Name
Takezawa Clinic
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroto Takezawa
Phone
052-837-7500
Facility Name
Hirosaki University School of Medicine & Hospital
City
Hirosaki
State/Province
Aomori
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shingo Sasaki
Phone
0172-33-5111
Facility Name
Ehime Prefectural Central Hospital
City
Matsuyama
State/Province
Ehime
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideki Okayama
Phone
089-947-1111
Facility Name
Saiseikai Matsuyama Hospital
City
Matsuyama
State/Province
Ehime
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koki Watanabe
Phone
089-951-6111
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akiyoshi Ogimoto
Phone
089-964-5111
Facility Name
University of Fukui Hospital
City
Yoshida-gun
State/Province
Fukui
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuichiro Shimao
Phone
0776-61-3111
Facility Name
Chiyo Clinic
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyoshi Hirayama
Phone
093-614-5558
Facility Name
Kitakyushu Municipal Yahata Hospital
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Ozumi
Phone
093-662-6565
Facility Name
Takagi Hospital
City
Okawa
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsuyoshi Yoshihiro
Phone
0944-87-0001
Facility Name
Kizawa memorial hospital
City
Minokamo
State/Province
Gifu
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takuma Aoyama
Phone
0574-25-2181
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norimichi Koitabashi
Phone
027-220-7111
Facility Name
Gunmaken Saiseikai Maebashi Hospital
City
Maebashi
State/Province
Gunma
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihiko Nakano
Phone
027-252-6011
Facility Name
Maebashi Red Cross Hospital
City
Maebashi
State/Province
Gunma
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoichi Tange
Phone
027-224-4585
Facility Name
Ota Memorial Hospital
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kotaro Yasuda
Phone
084-931-8650
Facility Name
National Hospital Organization Kure Medical Center
City
Kure
State/Province
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ritsu Tamura
Phone
0823-22-3111
Facility Name
Shobara Red Cross Hospital
City
Shobara
State/Province
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Sugino
Phone
0824-72-3111
Facility Name
Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Ogawa
Phone
0166-33-7171
Facility Name
Kihara cardiovascular clinic
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajime Kihara
Phone
0166-35-5555
Facility Name
Ebetsu City Hospital
City
Ebetsu
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenji Aoki
Phone
011-382-5151
Facility Name
Hokkaido Chuo Rosai Hospital
City
Iwami
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideyuki Takano
Phone
0126-22-1300
Facility Name
Otaru Kyokai Hospital
City
Otaru
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeo Kakinoki
Phone
0134-23-6234
Facility Name
Hokkaido Medical Center
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Okamoto
Phone
011-611-8111
Facility Name
JR Sapporo Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihito Tsuchida
Phone
011-208-7150
Facility Name
KKR Sapporo Medical Center
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naofumi Ito
Phone
011-841-4572
Facility Name
Sapporo City General Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetsuro Kohya
Phone
011-726-2211
Facility Name
Sapporo Medical Center NTT East
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noriyuki Miyamoto
Phone
011-623-7000
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetsuji Miura
Phone
011-611-2111
Facility Name
Sunagawa City Medical Center
City
Sunagawa
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takayuki Hirabayashi
Phone
0125-54-2131
Facility Name
Hyogo Brain and Heart Center
City
Himeji
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshinori Yasaka
Phone
079-293-3131
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenichi Hirata
Phone
078-382-5111
Facility Name
Hyogo College Of Medicine
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tohru Masuyama
Phone
0798-45-6111
Facility Name
Nishiwaki Municipal Hospital
City
Nishiwaki
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuichiro Shimao
Phone
0795-22-0111
Facility Name
Hitachi General Hospital
City
Hitachi
State/Province
Ibaraki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutaka Eki
Phone
0294-23-1111
Facility Name
Kanazawa Cardiovascular Hospital
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masatoshi Ikeda
Phone
076-253-8000
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masakazu Yamagishi
Phone
076-265-2000
Facility Name
Kagawa University
City
Kita-gun
State/Province
Kagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Ohmori
Phone
087-898-5111
Facility Name
St. Marianna University School of Medicine
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keisuke Kida
Phone
044-977-8111
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Naruke
Phone
042-778-8111
Facility Name
Nishi Yokohama Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideshi Takenobu
Phone
045-871-8855
Facility Name
Yokohamashintoshi Neurosurgical Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuhiro Ashida
Phone
045-911-2011
Facility Name
Kochi Medical School Hospital
City
Nankoku
State/Province
Kochi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Kitaoka
Phone
088-866-5811
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Shimokawa
Phone
022-717-7000
Facility Name
Nagasaki Goto Chuoh Hospital
City
Goto
State/Province
Nagasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saburo Kusumoto
Phone
0959-72-3181
Facility Name
Nara Hospital Kinki University Faculty of Medicine
City
Ikoma
State/Province
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manabu Shirotani
Phone
0743-77-0880
Facility Name
Nara Prefecture Western Medical Center
City
Ikoma
State/Province
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naofumi Doi
Phone
0745-32-0505
Facility Name
Nara Medical University
City
Kashihara
State/Province
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihiko Saito
Phone
0744-22-3051
Facility Name
Tsunan Metropolitan Hospital
City
Nakauonuma-gun
State/Province
Niigata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinichiro Ishikawa
Phone
025-765-3161
Facility Name
Ohama Daiichi Hospital
City
Naha
State/Province
Okinawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koichi Ohshiro
Phone
098-866-5171
Facility Name
Urasoe General Hospital
City
Urasoe
State/Province
Okinawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroki Uehara
Phone
098-878-0231
Facility Name
Osaka National Hospital
City
Chuo
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keiji Hirooka
Phone
06-6942-1331
Facility Name
Nozaki Tokushukai Hospital
City
Daito
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaaki Okutsu
Phone
072-874-1641
Facility Name
Kansai Medical University Hirakata Hospital
City
Hirakata
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ichiro Shiojima
Phone
072-804-0101
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihisa Anzai
Phone
06-6833-5012
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomohito Ohtani
Phone
06-6879-5111
Facility Name
Yayoigaoka Kage Hospital
City
Tosu
State/Province
Saga
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaru Takahashi
Phone
0942-87-3150
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiko Muramatsu
Phone
042-984-4111
Facility Name
Ikebukuro Hospital
City
Kawagoe
State/Province
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Nakahara
Phone
049-231-1552
Facility Name
Kusatsu General Hospital
City
Kusatsu
State/Province
Shiga
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsuyuki Wada
Phone
077-563-8866
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideharu Hayashi
Phone
053-435-2111
Facility Name
Juntendo Shizuoka Hospital
City
Izunokuni
State/Province
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoru Suwa
Phone
055-948-3111
Facility Name
Dokkyo Medical University
City
Shimotsuga-gun
State/Province
Tochigi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeru Toyoda
Phone
0282-86-1111
Facility Name
Ohta Clinic
City
Anan
State/Province
Tokushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Ohta
Phone
0883-36-2076
Facility Name
Nishiarai Heart Center Hospital
City
Adachi-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsumi Saito
Phone
03-5838-0730
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsutoshi Takagi
Phone
03-3813-3111
Facility Name
Medical Hospital of Tokyo Medical and Dental University
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhiro Maejima
Phone
03-3813-6111
Facility Name
Tokyo Metropolitan Tama Medical Center
City
Fuchu
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Tanaka
Phone
042-323-5111
Facility Name
Minamino Heart Clinic
City
Hachioji
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiki Hata
Phone
042-637-8101
Facility Name
Hino Municipal Hospital
City
Hino
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iwao Nakamura
Phone
042-581-2677
Facility Name
Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukihiko Momiyama
Phone
03-3411-0111
Facility Name
100
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Matsuo
Phone
03-6411-3666
Facility Name
Daisankitashinagawa hospital
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsuneo Mizumura
Phone
03-3474-1831
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Yamashina
Phone
03-3342-6111
Facility Name
Tottori University Hospital
City
Yonago
State/Province
Tottori
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryoji Kinugasa
Phone
0859-33-1111
Facility Name
Yamaguchi Grand Medical Center
City
Hofu
State/Province
Yamaguchi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masashi Kanemoto
Phone
0835-22-4411
Facility Name
Shimonoseki City Hospital
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eiji Karashima
Phone
083-231-4111
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeki Kobayashi
Phone
0836-22-2111
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
State/Province
Yamanashi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiko Nakamura
Phone
055-253-7111
Facility Name
Akita University Hospital
City
Akita
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Ito
Phone
018-834-1111
Facility Name
Hakujyuji Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuhide Tanaka
Phone
092-891-2511
Facility Name
Haradoi Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takaaki Sakai
Phone
092-691-3881
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomomi Ide
Phone
092-641-1151
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuichi Matsukawa
Phone
092-771-8151
Facility Name
Fukushima Daiichi Hospital
City
Fukushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomohiro Ogawa
Phone
024-557-5111
Facility Name
Ohara General Hospital
City
Fukushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osamu Yamaguchi
Phone
024-554-2001
Facility Name
Gifu University Hospital
City
Gifu
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinya Minatokuchi
Phone
058-230-6000
Facility Name
Hiroshima General Hospital of West Japan Railway Company
City
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroki Teragawa
Phone
082-262-1171
Facility Name
Hiroshima University Hospital
City
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuki Kihara
Phone
082-257-5555
Facility Name
Tenyoukai Central Hospital
City
Kagoshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuhiko Atsuchi
Phone
099-225-8650
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megumi Yamamuro
Phone
096-344-2111
Facility Name
Kyoto University Hospital
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsuyoshi Kimura
Phone
075-751-3111
Facility Name
Takenaka Clinic
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Takenaka
Phone
075-841-4777
Facility Name
Ebisu-hospital
City
Nagasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin Suzuki
Phone
095-824-9131
Facility Name
Medical Inc. Kosei-kai Nijigaoka Hospital
City
Nagasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minoru Hazama
Phone
095-856-1112
Facility Name
Nagasaki University Hospital
City
Nagasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Maemura
Phone
095-819-7200
Facility Name
Nara City Hospital
City
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manabu Horii
Phone
0742-24-1251
Facility Name
Nara Prefecture General Medical Center
City
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fumitaka Inoue
Phone
0742-46-6001
Facility Name
Kuwana hospital
City
Niigata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiro Minagawa
Phone
025-273-2251
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tohru Minamino
Phone
025-223-6161
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazufumi Nakamura
Phone
086-223-7151
Facility Name
Graduate School of Medicine and Faculty of Medicine
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihisa Hanatani
Phone
06-6645-2121
Facility Name
JCHO Osaka Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinji Hasegawa
Phone
06-6411-5451
Facility Name
Kitano Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takao Kato
Phone
06-6312-1221
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenji Fujii
Phone
06-6341-8651
Facility Name
Saitama Medical Center Jichi Medical University
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinichi Momomura
Phone
048-647-2111
Facility Name
Tokushima University Hospital
City
Tokushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masataka Sata
Phone
088-631-3111
Facility Name
Wakayama Medical University Hospital
City
Wakayama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Akasaka
Phone
073-447-2300
Facility Name
Kanoiwa General Hospital
City
Yamanashi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimio Yamamoto
Phone
0553-22-2511

12. IPD Sharing Statement

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The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)

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