Special Drug Use Surveillance for Entresto Tablets
Launched by NOVARTIS PHARMACEUTICALS · Mar 1, 2021
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the RMP-specified additional pharmacovigilance activities.
Gender
ALL
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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tokorozawa, Saitama, Japan
Hachioji, Tokyo, Japan
Kobe City, Hyogo, Japan
Yokohama City, Kanagawa, Japan
Hachioji City, Tokyo, Japan
Chikushino City, Fukuka, Japan
Yachiyo City, Chiba, Japan
Kakogawa City, Hyogo, Japan
Kyoto, , Japan
Iki City, Nagasaki, Japan
Nasushiobara, Tochigi, Japan
Minato Ku, Tokyo, Japan
Sakata City, Yamagata, Japan
Gifu, , Japan
Ichinomiya, Aichi, Japan
Nagoya, Aichi, Japan
Nishio, Aichi, Japan
Obu, Aichi, Japan
Yatomi, Aichi, Japan
Funabashi, Chiba, Japan
Kashiwa, Chiba, Japan
Sakura, Chiba, Japan
Imabari, Ehime, Japan
Matsuyama, Ehime, Japan
Kasuya Gun, Fukuoka, Japan
Ukiha, Fukuoka, Japan
Iwaki, Fukushima, Japan
Maebashi, Gunma, Japan
Takasaki, Gunma, Japan
Fuchu, Hiroshima, Japan
Mihara, Hiroshima, Japan
Takehara, Hiroshima, Japan
Abashiri, Hokkaido, Japan
Fukagawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Ishikari, Hokkaido, Japan
Iwamizawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Akashi, Hyogo, Japan
Awaji, Hyogo, Japan
Himeji, Hyogo, Japan
Kakogawa, Hyogo, Japan
Kobe, Hyogo, Japan
Nishinomiya, Hyogo, Japan
Takarazuka City, Hyogo, Japan
Mito, Ibaraki, Japan
Kanazawa, Ishikawa, Japan
Morioka, Iwate, Japan
Takamatsu, Kagawa, Japan
Fujisawa, Kanagawa, Japan
Kamakura, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Mukou City, Kyoto, Japan
Iga, Mie, Japan
Tsu City, Mie, Japan
Watarai, Mie, Japan
Higashimatsushima, Miyagi, Japan
Shiogama, Miyagi, Japan
Saito, Miyazaki, Japan
Sasebo, Nagasaki, Japan
Kita Katsuragi Gun, Nara, Japan
Kurashiki, Okayama, Japan
Urasoe, Okinawa, Japan
Sakai, Osaka, Japan
Kishima Gun, Saga, Japan
Ureshino, Saga, Japan
Kawaguchi, Saitama, Japan
Sayama, Saitama, Japan
Toda, Saitama, Japan
Higashiohmi, Shiga, Japan
Gotenba, Shizuoka, Japan
Hamamatsu, Shizuoka, Japan
Sunto Gun, Shizuoka, Japan
Utsunomiya, Tochigi, Japan
Adachi, Tokyo, Japan
Akiruno, Tokyo, Japan
Katsushika, Tokyo, Japan
Machida, Tokyo, Japan
Minato, Tokyo, Japan
Nakano, Tokyo, Japan
Ota, Tokyo, Japan
Toshima, Tokyo, Japan
Takaoka, Toyama, Japan
Shinjo, Yamagata, Japan
Shimonoseki, Yamaguchi, Japan
Hiroshima, , Japan
Kumamoto, , Japan
Nagasaki, , Japan
Oita, , Japan
Osaka, , Japan
Saitama, , Japan
Shizuoka, , Japan
Tokushima, , Japan
Toyama, , Japan
Wakayama, , Japan
Yamaguchi, , Japan
Iga, Mie, Japan
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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