Special Drug Use Surveillance for Entresto Tablets

Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)

ClinicalTrials.gov Identifier: NCT04781881

Novartis Reference Number: CLCZ696B1401

Last Update: Nov 10, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.

Condition 
Chronic Heart Failure
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
660 participants
Start date 
Mar 04, 2021
Completion date 
Oct 31, 2023
Gender 
All
Age(s)
99 Years and older (Child, Adult, Older Adult)

Interventions

Drug
Entresto
There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Patients must provide written consent to cooperate in this study before the start of Entresto
Patients using Entresto for the first time for the following indication Indication: chronic heart failure patients on standard of care for chronic heart failure

Exclusion Criteria:

Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto
The following patients for whom Entresto is contraindicated in the package insert Patients with a history of hypersensitivity to any of the Entresto ingredients Patients with a history of angioedema (angiotensin II receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.) Diabetic patients on aliskiren fumarate Patients with severe hepatic impairment (Child-Pugh class C) Pregnant or possibly pregnant women

Study Locations

Japan
Novartis Investigative Site
Recruiting
Ichinomiya, 493-0004
Aichi
Japan
Novartis Investigative Site
Recruiting
Ichinomiya, 494-0001
Aichi
Japan
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Nagoya, 460-0004
Aichi
Japan
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Nishio, 444-0403
Aichi
Japan
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Obu, 474-0044
Aichi
Japan
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Yatomi, 498-0048
Aichi
Japan
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Funabashi, 273-0005
Chiba
Japan
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Funabashi, 273-0031
Chiba
Japan
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Kashiwa, 277-0054
Chiba
Japan
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Sakura, 285-8765
Chiba
Japan
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Yachiyo-city, 276-8524
Chiba
Japan
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Imabari, 794-0052
Ehime
Japan
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Matsuyama, 790-0932
Ehime
Japan
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Chikushino-city, 818-8516
Fukuka
Japan
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Kasuya-gun, 811-2311
Fukuoka
Japan
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Ukiha, 839-1306
Fukuoka
Japan
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Iwaki, 979-0201
Fukushima
Japan
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Maebashi, 371-0004
Gunma
Japan
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Takasaki, 370-0046
Gunma
Japan
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Takasaki, 370-3513
Gunma
Japan
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Fuchu, 726-0013
Hiroshima
Japan
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Abashiri, 092-0235
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Eniwa, 061-1376
Hokkaido
Japan
Novartis Investigative Site
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Fukagawa, 074-0006
Hokkaido
Japan
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Hakodate, 041-8522
Hokkaido
Japan
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Ishikari, 061-3217
Hokkaido
Japan
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Iwamizawa, 068-0004
Hokkaido
Japan
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Sapporo, 004-0052
Hokkaido
Japan
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Sapporo, 007-0849
Hokkaido
Japan
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Sapporo, 065-0012
Hokkaido
Japan
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Sapporo, 065-0027
Hokkaido
Japan
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Akashi, 673-0023
Hyogo
Japan
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Awaji, 656-2131
Hyogo
Japan
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Himeji, 670-0811
Hyogo
Japan
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Himeji, 672-8035
Hyogo
Japan
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Itami-city, 664-0858
Hyogo
Japan
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Kakogawa-city, 675-0101
Hyogo
Japan
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Kakogawa, 675-0017
Hyogo
Japan
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Kobe-city, 650-0047
Hyogo
Japan
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Kobe, 654-0121
Hyogo
Japan
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Kobe, 657-0051
Hyogo
Japan
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Nishinomiya, 663-8107
Hyogo
Japan
Novartis Investigative Site
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Takarazuka-city, 665-0861
Hyogo
Japan
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Takarazuka-city, 665-0873
Hyogo
Japan
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Mito, 310-0004
Ibaraki
Japan
Novartis Investigative Site
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Mito, 310-0841
Ibaraki
Japan
Novartis Investigative Site
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Kanazawa, 920-0007
Ishikawa
Japan
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Morioka, 020-0871
Iwate
Japan
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Takamatsu, 761-8063
Kagawa
Japan
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Aira, 899-5302
Kagoshima
Japan
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Fujisawa, 252-0802
Kanagawa
Japan
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Sagamihara, 252-0105
Kanagawa
Japan
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Yokohama-city, 236 0037
Kanagawa
Japan
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Mukou-City, 617-0002
Kyoto
Japan
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Iga, 518-0842
Mie
Japan
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Tsu-City, 514-0823
Mie
Japan
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Tsu-city, 514-8508
Mie
Japan
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Watarai, 516-0101
Mie
Japan
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Higashimatsushima, 981-0501
Miyagi
Japan
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Shiogama, 985-0087
Miyagi
Japan
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Saito, 881-0003
Miyazaki
Japan
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Okaya, 394-8512
Nagano
Japan
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Iki-city, 811-5135
Nagasaki
Japan
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Sasebo, 857-0871
Nagasaki
Japan
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Kita-Katsuragi-gun, 636-0002
Nara
Japan
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Kurashiki, 710-1101
Okayama
Japan
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Kurashiki, 713-8121
Okayama
Japan
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Urasoe, 901-2132
Okinawa
Japan
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Sakai, 590-0111
Osaka
Japan
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Kishima-gun, 849-0401
Saga
Japan
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Nobeoka, 882-0802
Saga
Japan
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Ageo, 362-0036
Saitama
Japan
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Kawaguchi, 332-0001
Saitama
Japan
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Kawaguchi, 333-0847
Saitama
Japan
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Sayama, 350-1305
Saitama
Japan
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Toda, 335-0013
Saitama
Japan
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Tokorozawa, 351-1151
Saitama
Japan
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Tokorozawa, 359-1142
Saitama
Japan
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Higashiohmi, 527-0134
Shiga
Japan
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Gotenba, 412-0043
Shizuoka
Japan
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Hamamatsu, 434-0011
Shizuoka
Japan
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Sunto-gun, 411-0917
Shizuoka
Japan
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Susono, 410-1112
Shizuoka
Japan
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Nasushiobara, 329-2763
Tochigi
Japan
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Adachi, 123-0845
Tokyo
Japan
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Adachi, 123-0864
Tokyo
Japan
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Akiruno, 197-0804
Tokyo
Japan
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Hachioji-city, 192-0918
Tokyo
Japan
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Hachioji, 192-0046
Tokyo
Japan
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Katsushika, 124-0021
Tokyo
Japan
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Machida, 194-0013
Tokyo
Japan
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Machida, 195-0074
Tokyo
Japan
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Minato-ku, 108-8329
Tokyo
Japan
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Minato, 106-0031
Tokyo
Japan
Novartis Investigative Site
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Nakano, 165-0022
Tokyo
Japan
Novartis Investigative Site
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Ota, 144-0051
Tokyo
Japan
Novartis Investigative Site
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Ota, 144-8501
Tokyo
Japan
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Toshima, 171-0033
Tokyo
Japan
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Takaoka, 939-1104
Toyama
Japan
Novartis Investigative Site
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Sakata-city, 998-8501
Yamagata
Japan
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Shinjo, 996-0035
Yamagata
Japan
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Shimonoseki, 759-6301
Yamaguchi
Japan
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Fukuoka, 810-0004
-
Japan
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Gifu, 500-8384
-
Japan
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Hiroshima, 731-0102
-
Japan
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Hiroshima, 731-0113
-
Japan
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Kagoshima, 891-0102
-
Japan
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Kumamoto, 861-4115
-
Japan
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Kumamoto, 862-0916
-
Japan
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Kumamoto, 862-0924
-
Japan
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Kyoto, 612-8555
-
Japan
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Oita, 870-0955
-
Japan
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Oita, 879-7761
-
Japan
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Osaka, 531-0071
-
Japan
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Osaka, 533-0001
-
Japan
Novartis Investigative Site
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Osaka, 533-0013
-
Japan
Novartis Investigative Site
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Osaka, 537-0024
-
Japan
Novartis Investigative Site
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Saitama, 330-0855
-
Japan
Novartis Investigative Site
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Saitama, 338-0837
-
Japan
Novartis Investigative Site
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Shizuoka, 420-0867
-
Japan
Novartis Investigative Site
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Tokushima, 770-8079
-
Japan
Novartis Investigative Site
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Toyama, 939-8081
-
Japan
Novartis Investigative Site
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Wakayama, 641-0006
-
Japan
Novartis Investigative Site
Recruiting
Yamaguchi, 754-0002
-
Japan

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