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: May 03, 2022

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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
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.
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.
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.
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
Obu, 474-0044
Aichi
Japan
Novartis Investigative Site
Recruiting
Kasuya-gun, 811-2311
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Ukiha, 839-1306
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Iwaki, 979-0201
Fukushima
Japan
Novartis Investigative Site
Recruiting
Koriyama city, 963-8052
Fukushima
Japan
Novartis Investigative Site
Recruiting
Takasaki, 370-3513
Gunma
Japan
Novartis Investigative Site
Recruiting
Takehara, 725-0012
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Eniwa, 061-1376
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodate, 041-8522
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ishikari, 061-3217
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Iwamizawa, 068-0004
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Takamatsu, 761-8063
Kagawa
Japan
Novartis Investigative Site
Recruiting
Kamakura, 248-0011
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Higashimatsushima, 981-0501
Miyagi
Japan
Novartis Investigative Site
Recruiting
Shiogama, 985-0087
Miyagi
Japan
Novartis Investigative Site
Recruiting
Saito, 881-0003
Miyazaki
Japan
Novartis Investigative Site
Recruiting
Okaya, 394-8512
Nagano
Japan
Novartis Investigative Site
Recruiting
Urasoe, 901-2132
Okinawa
Japan
Novartis Investigative Site
Recruiting
Ageo, 362-0036
Saitama
Japan
Novartis Investigative Site
Recruiting
Kawaguchi, 333-0847
Saitama
Japan
Novartis Investigative Site
Recruiting
Higashiohmi, 527-0134
Shiga
Japan
Novartis Investigative Site
Recruiting
Gotenba, 412-0043
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Utsunomiya, 321-0917
Tochigi
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0845
Tokyo
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0864
Tokyo
Japan
Novartis Investigative Site
Recruiting
Akiruno, 197-0804
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 192-0918
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji, 192-0046
Tokyo
Japan
Novartis Investigative Site
Recruiting
Minato, 106-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Nakano, 165-0022
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-0051
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-8501
Tokyo
Japan
Novartis Investigative Site
Recruiting
Sakata-city, 998-8501
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shinjo, 996-0035
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shimonoseki, 759-6301
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Gifu, 500-8384
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 861-4115
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0916
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0924
-
Japan
Novartis Investigative Site
Recruiting
Oita, 870-0955
-
Japan
Novartis Investigative Site
Recruiting
Oita, 879-7761
-
Japan
Novartis Investigative Site
Recruiting
Shizuoka, 420-0867
-
Japan
Novartis Investigative Site
Recruiting
Tokushima, 770-8079
-
Japan
Novartis Investigative Site
Recruiting
Yamaguchi, 754-0002
-
Japan
Novartis Investigative Site
Recruiting
Obu, 474-0044
Aichi
Japan
Novartis Investigative Site
Recruiting
Kasuya-gun, 811-2311
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Ukiha, 839-1306
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Iwaki, 979-0201
Fukushima
Japan
Novartis Investigative Site
Recruiting
Koriyama city, 963-8052
Fukushima
Japan
Novartis Investigative Site
Recruiting
Takasaki, 370-3513
Gunma
Japan
Novartis Investigative Site
Recruiting
Takehara, 725-0012
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Eniwa, 061-1376
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodate, 041-8522
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ishikari, 061-3217
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Iwamizawa, 068-0004
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Takamatsu, 761-8063
Kagawa
Japan
Novartis Investigative Site
Recruiting
Kamakura, 248-0011
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Higashimatsushima, 981-0501
Miyagi
Japan
Novartis Investigative Site
Recruiting
Shiogama, 985-0087
Miyagi
Japan
Novartis Investigative Site
Recruiting
Saito, 881-0003
Miyazaki
Japan
Novartis Investigative Site
Recruiting
Okaya, 394-8512
Nagano
Japan
Novartis Investigative Site
Recruiting
Urasoe, 901-2132
Okinawa
Japan
Novartis Investigative Site
Recruiting
Ageo, 362-0036
Saitama
Japan
Novartis Investigative Site
Recruiting
Kawaguchi, 333-0847
Saitama
Japan
Novartis Investigative Site
Recruiting
Higashiohmi, 527-0134
Shiga
Japan
Novartis Investigative Site
Recruiting
Gotenba, 412-0043
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Utsunomiya, 321-0917
Tochigi
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0845
Tokyo
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0864
Tokyo
Japan
Novartis Investigative Site
Recruiting
Akiruno, 197-0804
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 192-0918
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji, 192-0046
Tokyo
Japan
Novartis Investigative Site
Recruiting
Minato, 106-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Nakano, 165-0022
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-0051
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-8501
Tokyo
Japan
Novartis Investigative Site
Recruiting
Sakata-city, 998-8501
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shinjo, 996-0035
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shimonoseki, 759-6301
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Gifu, 500-8384
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 861-4115
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0916
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0924
-
Japan
Novartis Investigative Site
Recruiting
Oita, 870-0955
-
Japan
Novartis Investigative Site
Recruiting
Oita, 879-7761
-
Japan
Novartis Investigative Site
Recruiting
Shizuoka, 420-0867
-
Japan
Novartis Investigative Site
Recruiting
Tokushima, 770-8079
-
Japan
Novartis Investigative Site
Recruiting
Yamaguchi, 754-0002
-
Japan
Novartis Investigative Site
Recruiting
Obu, 474-0044
Aichi
Japan
Novartis Investigative Site
Recruiting
Kasuya-gun, 811-2311
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Ukiha, 839-1306
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Iwaki, 979-0201
Fukushima
Japan
Novartis Investigative Site
Recruiting
Koriyama city, 963-8052
Fukushima
Japan
Novartis Investigative Site
Recruiting
Takasaki, 370-3513
Gunma
Japan
Novartis Investigative Site
Recruiting
Takehara, 725-0012
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Eniwa, 061-1376
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodate, 041-8522
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ishikari, 061-3217
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Iwamizawa, 068-0004
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Takamatsu, 761-8063
Kagawa
Japan
Novartis Investigative Site
Recruiting
Kamakura, 248-0011
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Higashimatsushima, 981-0501
Miyagi
Japan
Novartis Investigative Site
Recruiting
Shiogama, 985-0087
Miyagi
Japan
Novartis Investigative Site
Recruiting
Saito, 881-0003
Miyazaki
Japan
Novartis Investigative Site
Recruiting
Okaya, 394-8512
Nagano
Japan
Novartis Investigative Site
Recruiting
Urasoe, 901-2132
Okinawa
Japan
Novartis Investigative Site
Recruiting
Ageo, 362-0036
Saitama
Japan
Novartis Investigative Site
Recruiting
Kawaguchi, 333-0847
Saitama
Japan
Novartis Investigative Site
Recruiting
Higashiohmi, 527-0134
Shiga
Japan
Novartis Investigative Site
Recruiting
Gotenba, 412-0043
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Utsunomiya, 321-0917
Tochigi
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0845
Tokyo
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0864
Tokyo
Japan
Novartis Investigative Site
Recruiting
Akiruno, 197-0804
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 192-0918
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji, 192-0046
Tokyo
Japan
Novartis Investigative Site
Recruiting
Minato, 106-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Nakano, 165-0022
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-0051
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-8501
Tokyo
Japan
Novartis Investigative Site
Recruiting
Sakata-city, 998-8501
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shinjo, 996-0035
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shimonoseki, 759-6301
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Gifu, 500-8384
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 861-4115
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0916
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0924
-
Japan
Novartis Investigative Site
Recruiting
Oita, 870-0955
-
Japan
Novartis Investigative Site
Recruiting
Oita, 879-7761
-
Japan
Novartis Investigative Site
Recruiting
Shizuoka, 420-0867
-
Japan
Novartis Investigative Site
Recruiting
Tokushima, 770-8079
-
Japan
Novartis Investigative Site
Recruiting
Yamaguchi, 754-0002
-
Japan
Novartis Investigative Site
Recruiting
Obu, 474-0044
Aichi
Japan
Novartis Investigative Site
Recruiting
Kasuya-gun, 811-2311
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Ukiha, 839-1306
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Iwaki, 979-0201
Fukushima
Japan
Novartis Investigative Site
Recruiting
Koriyama city, 963-8052
Fukushima
Japan
Novartis Investigative Site
Recruiting
Takasaki, 370-3513
Gunma
Japan
Novartis Investigative Site
Recruiting
Takehara, 725-0012
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Eniwa, 061-1376
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodate, 041-8522
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ishikari, 061-3217
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Iwamizawa, 068-0004
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Takamatsu, 761-8063
Kagawa
Japan
Novartis Investigative Site
Recruiting
Kamakura, 248-0011
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Higashimatsushima, 981-0501
Miyagi
Japan
Novartis Investigative Site
Recruiting
Shiogama, 985-0087
Miyagi
Japan
Novartis Investigative Site
Recruiting
Saito, 881-0003
Miyazaki
Japan
Novartis Investigative Site
Recruiting
Okaya, 394-8512
Nagano
Japan
Novartis Investigative Site
Recruiting
Urasoe, 901-2132
Okinawa
Japan
Novartis Investigative Site
Recruiting
Ageo, 362-0036
Saitama
Japan
Novartis Investigative Site
Recruiting
Kawaguchi, 333-0847
Saitama
Japan
Novartis Investigative Site
Recruiting
Higashiohmi, 527-0134
Shiga
Japan
Novartis Investigative Site
Recruiting
Gotenba, 412-0043
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Utsunomiya, 321-0917
Tochigi
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0845
Tokyo
Japan
Novartis Investigative Site
Recruiting
Adachi, 123-0864
Tokyo
Japan
Novartis Investigative Site
Recruiting
Akiruno, 197-0804
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 192-0918
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji, 192-0046
Tokyo
Japan
Novartis Investigative Site
Recruiting
Minato, 106-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Nakano, 165-0022
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-0051
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota, 144-8501
Tokyo
Japan
Novartis Investigative Site
Recruiting
Sakata-city, 998-8501
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shinjo, 996-0035
Yamagata
Japan
Novartis Investigative Site
Recruiting
Shimonoseki, 759-6301
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Gifu, 500-8384
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 861-4115
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0916
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 862-0924
-
Japan
Novartis Investigative Site
Recruiting
Oita, 870-0955
-
Japan
Novartis Investigative Site
Recruiting
Oita, 879-7761
-
Japan
Novartis Investigative Site
Recruiting
Shizuoka, 420-0867
-
Japan
Novartis Investigative Site
Recruiting
Tokushima, 770-8079
-
Japan
Novartis Investigative Site
Recruiting
Yamaguchi, 754-0002
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]