Clinical trial NCT04781881: Special Drug Use Surveillance for Entresto Tablets
Official title: Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
Entresto
Japan
sacubitril/valsartan
sacubitril valsartan sodium hydrate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 688
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese patients using Entresto for the newly approved indication of "chronic heart failure"

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

Detailed description: 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.

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

Primary outcomes:
measure: To evaluate the safety of Entresto in chronic heart failure patients
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: To evaluate the impact of risk factors
timeFrame: Up to 52 weeks
measure: To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs
timeFrame: Up to 52 weeks
measure: EAIR for each of the clinical events
timeFrame: Up to 52 weeks
measure: Kaplan-Meier curve for each of the clinical events
timeFrame: Up to 52 weeks
measure: Total frequency of hospitalization due to heart failure
timeFrame: Up to 52 weeks
measure: To investigate data on the administration of Entresto in clinical use
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nishio
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Obu
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Yatomi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Funabashi
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Sakura
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yachiyo-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Imabari
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Chikushino-city
country: Japan
facility: Novartis Investigative Site
state: Fukuka
city: Kasuya-gun
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Ukiha
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Iwaki
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Maebashi
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Takasaki
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Fuchu
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Mihara
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Takehara
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Takehara
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Abashiri
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Fukagawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Hakodate
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Ishikari
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Iwamizawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Akashi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Awaji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kakogawa-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kakogawa
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Takarazuka-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Takarazuka-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Mito
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Mito
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Takamatsu
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Fujisawa
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kamakura
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Mukou-City
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Iga
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Tsu-City
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Tsu-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Watarai
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Higashimatsushima
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Shiogama
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Saito
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Iki-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Sasebo
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Kita-Katsuragi-gun
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Urasoe
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Sakai
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kishima-gun
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Ureshino
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Kawaguchi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawaguchi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Sayama
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Toda
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Higashiohmi
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Gotenba
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Nasushiobara
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Utsunomiya
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Adachi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Adachi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Akiruno
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nakano
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Takaoka
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Sakata-city
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Shinjo
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Shimonoseki
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Gifu
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Tokushima
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
city: Yamaguchi
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: