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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisoprolol group | Active Comparator | 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). |
|
| Carvedilol group | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug |
| ||
| Carvedilol |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day) | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: New York Heart Association (NYHA) Functional Classification | 24 and 48 weeks | |
| Efficacy: Left Ventricular Ejection Fraction (LVEF) | 24 and 48 weeks | |
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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.
Exclusion Criteria:
Patients who meet any of the following exclusion criteria at the time of registration will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yukio Yamada | Contact | 03-6229-8936 | Cibis-j@mebix.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiroyuki Tsutsui | Hokkaido University Graduate School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banbuntane Hotokukai Hospital | Recruiting | Nagoya | Aichi-ken | Japan |
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|
| Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV) |
| 24 and 48 weeks |
| Efficacy: Heart rate | 24 and 48 weeks |
| Efficacy: Plasma brain natriuretic peptide (BNP) | 24 and 48 weeks |
| Safety: All deaths | 48 weeks |
| Safety: Deaths with cardiovascular causes | 48 weeks |
| Safety: Hospitalization for cardiovascular causes | 48 weeks |
| 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. | 48 weeks |
| Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure) | 48 weeks |
| Safety: Sudden deaths, including deaths due to arrhythmia | 48 weeks |
| Safety: Deaths with non-cardiovascular causes | 48 weeks |
| Safety: Adverse events | 48 weeks |
| Safety: Changes in clinical laboratory test results | 48 weeks |
| Chukyo Hospital | Recruiting | Nagoya | Aichi-ken | Japan |
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| Nagoya City University Hospital | Recruiting | Nagoya | Aichi-ken | Japan |
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| Takezawa Clinic | Recruiting | Nagoya | Aichi-ken | Japan |
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| Akita University Hospital | Recruiting | Akita | Akita | Japan |
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| Hirosaki University School of Medicine & Hospital | Recruiting | Hirosaki | Aomori | Japan |
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| Ehime Prefectural Central Hospital | Recruiting | Matsuyama | Ehime | Japan |
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| Saiseikai Matsuyama Hospital | Recruiting | Matsuyama | Ehime | Japan |
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| Ehime University Hospital | Recruiting | Tōon | Ehime | Japan |
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| University of Fukui Hospital | Recruiting | Yoshida-gun | Fukui | Japan |
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| Hakujyuji Hospital | Recruiting | Fukuoka | Fukuoka | Japan |
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| Haradoi Hospital | Recruiting | Fukuoka | Fukuoka | Japan |
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| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | Japan |
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| Saiseikai Fukuoka General Hospital | Recruiting | Fukuoka | Fukuoka | Japan |
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| Chiyo Clinic | Recruiting | Kitakyushu | Fukuoka | Japan |
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| Kitakyushu Municipal Yahata Hospital | Recruiting | Kitakyushu | Fukuoka | Japan |
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| Takagi Hospital | Recruiting | Ōkawa | Fukuoka | Japan |
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| Fukushima Daiichi Hospital | Recruiting | Fukushima | Fukushima | Japan |
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| Ohara General Hospital | Recruiting | Fukushima | Fukushima | Japan |
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| Gifu University Hospital | Recruiting | Gifu | Gifu | Japan |
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| Kizawa memorial hospital | Recruiting | Minokamo | Gifu | Japan |
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| Gunma University Hospital | Recruiting | Maebashi | Gunma | Japan |
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| Gunmaken Saiseikai Maebashi Hospital | Recruiting | Maebashi | Gunma | Japan |
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| Maebashi Red Cross Hospital | Recruiting | Maebashi | Gunma | Japan |
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| Ota Memorial Hospital | Recruiting | Fukuyama | Hiroshima | Japan |
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| Hiroshima General Hospital of West Japan Railway Company | Recruiting | Hiroshima | Hiroshima | Japan |
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| Hiroshima University Hospital | Recruiting | Hiroshima | Hiroshima | Japan |
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| National Hospital Organization Kure Medical Center | Recruiting | Kure | Hiroshima | Japan |
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| Shobara Red Cross Hospital | Recruiting | Shōbara | Hiroshima | Japan |
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| Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital | Recruiting | Asahikawa | Hokkaido | Japan |
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| Kihara cardiovascular clinic | Recruiting | Asahikawa | Hokkaido | Japan |
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| Ebetsu City Hospital | Recruiting | Ebetsu | Hokkaido | Japan |
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| Hokkaido Chuo Rosai Hospital | Recruiting | Iwami | Hokkaido | Japan |
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| Otaru Kyokai Hospital | Recruiting | Otaru | Hokkaido | Japan |
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| Hokkaido Medical Center | Recruiting | Sapporo | Hokkaido | Japan |
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| JR Sapporo Hospital | Recruiting | Sapporo | Hokkaido | Japan |
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| KKR Sapporo Medical Center | Recruiting | Sapporo | Hokkaido | Japan |
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| Sapporo City General Hospital | Recruiting | Sapporo | Hokkaido | Japan |
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| Sapporo Medical Center NTT East | Recruiting | Sapporo | Hokkaido | Japan |
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| Sapporo Medical University Hospital | Recruiting | Sapporo | Hokkaido | Japan |
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| Sunagawa City Medical Center | Recruiting | Sunagawa | Hokkaido | Japan |
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| Hyogo Brain and Heart Center | Recruiting | Himeji | Hyōgo | Japan |
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| Kobe University Hospital | Recruiting | Kobe | Hyōgo | Japan |
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| Hyogo College Of Medicine | Recruiting | Nishinomiya | Hyōgo | Japan |
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| Nishiwaki Municipal Hospital | Recruiting | Nishiwaki | Hyōgo | Japan |
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| Hitachi General Hospital | Recruiting | Hitachi | Ibaraki | Japan |
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| Kanazawa Cardiovascular Hospital | Recruiting | Kanazawa | Ishikawa-ken | Japan |
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| Kanazawa University Hospital | Recruiting | Kanazawa | Ishikawa-ken | Japan |
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| Kagawa University | Recruiting | Kita-gun | Kagawa-ken | Japan |
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| Tenyoukai Central Hospital | Recruiting | Kagoshima | Kagoshima-ken | Japan |
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| St. Marianna University School of Medicine | Recruiting | Kawasaki | Kanagawa | Japan |
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| Kitasato University Hospital | Recruiting | Sagamihara | Kanagawa | Japan |
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| Nishi Yokohama Hospital | Recruiting | Yokohama | Kanagawa | Japan |
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| Yokohamashintoshi Neurosurgical Hospital | Recruiting | Yokohama | Kanagawa | Japan |
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| Kochi Medical School Hospital | Recruiting | Nankoku | Kochi | Japan |
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| Kumamoto University Hospital | Recruiting | Kumamoto | Kumamoto | Japan |
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| Kyoto University Hospital | Recruiting | Kyoto | Kyoto | Japan |
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| Takenaka Clinic | Recruiting | Kyoto | Kyoto | Japan |
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| Tohoku University Hospital | Recruiting | Sendai | Miyagi | Japan |
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| Nagasaki Goto Chuoh Hospital | Recruiting | Gotō | Nagasaki | Japan |
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| Ebisu-hospital | Recruiting | Nagasaki | Nagasaki | Japan |
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| Medical Inc. Kosei-kai Nijigaoka Hospital | Recruiting | Nagasaki | Nagasaki | Japan |
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| Nagasaki University Hospital | Recruiting | Nagasaki | Nagasaki | Japan |
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| Nara Hospital Kinki University Faculty of Medicine | Recruiting | Ikoma | Nara | Japan |
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| Nara Prefecture Western Medical Center | Recruiting | Ikoma | Nara | Japan |
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| Nara Medical University | Recruiting | Kashihara | Nara | Japan |
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| Nara City Hospital | Recruiting | Nara | Nara | Japan |
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| Nara Prefecture General Medical Center | Recruiting | Nara | Nara | Japan |
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| Tsunan Metropolitan Hospital | Recruiting | Nakauonuma-gun | Niigata | Japan |
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| Kuwana hospital | Recruiting | Niigata | Niigata | Japan |
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| Niigata University Medical & Dental Hospital | Recruiting | Niigata | Niigata | Japan |
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| Okayama University Hospital | Recruiting | Okayama | Okayama-ken | Japan |
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| Ohama Daiichi Hospital | Recruiting | Naha | Okinawa | Japan |
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| Urasoe General Hospital | Recruiting | Urasoe | Okinawa | Japan |
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| Osaka National Hospital | Recruiting | Chuo | Osaka | Japan |
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| Nozaki Tokushukai Hospital | Recruiting | Daitō | Osaka | Japan |
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| Kansai Medical University Hirakata Hospital | Recruiting | Hirakata | Osaka | Japan |
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| Graduate School of Medicine and Faculty of Medicine | Recruiting | Osaka | Osaka | Japan |
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| JCHO Osaka Hospital | Recruiting | Osaka | Osaka | Japan |
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| Kitano Hospital | Recruiting | Osaka | Osaka | Japan |
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| Sakurabashi Watanabe Hospital | Recruiting | Osaka | Osaka | Japan |
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| National Cerebral and Cardiovascular Center | Recruiting | Suita | Osaka | Japan |
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| Osaka University Hospital | Recruiting | Suita | Osaka | Japan |
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| Yayoigaoka Kage Hospital | Recruiting | Tosu | Saga-ken | Japan |
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| Saitama Medical University International Medical Center | Recruiting | Hidaka | Saitama | Japan |
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| Ikebukuro Hospital | Recruiting | Kawagoe | Saitama | Japan |
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| Saitama Medical Center Jichi Medical University | Recruiting | Saitama | Saitama | Japan |
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| Kusatsu General Hospital | Recruiting | Kusatsu | Shiga | Japan |
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| Hamamatsu University Hospital | Recruiting | Hamamatsu | Shizuoka | Japan |
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| Juntendo Shizuoka Hospital | Recruiting | Izunokuni | Shizuoka | Japan |
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| Dokkyo Medical University | Recruiting | Shimotsuga-gun | Tochigi | Japan |
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| Ohta Clinic | Recruiting | Anan | Tokushima | Japan |
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| Tokushima University Hospital | Recruiting | Tokushima | Tokushima | Japan |
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| Nishiarai Heart Center Hospital | Recruiting | Adachi-ku | Tokyo | Japan |
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| Juntendo University Hospital | Recruiting | Bunkyo-ku | Tokyo | Japan |
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| Medical Hospital of Tokyo Medical and Dental University | Recruiting | Bunkyo-ku | Tokyo | Japan |
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| Tokyo Metropolitan Tama Medical Center | Recruiting | Fuchū | Tokyo | Japan |
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| Minamino Heart Clinic | Recruiting | Hachiōji | Tokyo | Japan |
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| Hino Municipal Hospital | Recruiting | Hino | Tokyo | Japan |
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| Tokyo Medical Center | Recruiting | Meguro-ku | Tokyo | Japan |
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| 100 | Recruiting | Setagaya-ku | Tokyo | Japan |
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| Daisankitashinagawa hospital | Recruiting | Shinagawa-ku | Tokyo | Japan |
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| Tokyo Medical University Hospital | Recruiting | Shinjuku-ku | Tokyo | Japan |
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| Tottori University Hospital | Recruiting | Yonago | Tottori | Japan |
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| Wakayama Medical University Hospital | Recruiting | Wakayama | Wakayama | Japan |
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| Yamaguchi Grand Medical Center | Recruiting | Hōfu | Yamaguchi | Japan |
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| Shimonoseki City Hospital | Recruiting | Shimonoseki | Yamaguchi | Japan |
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| Yamaguchi University Hospital | Recruiting | Ube | Yamaguchi | Japan |
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| Yamanashi Prefectural Central Hospital | Recruiting | Kofu | Yamanashi | Japan |
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| Kanoiwa General Hospital | Recruiting | Yamanashi | Yamanashi | Japan |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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