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NCT04781881 Clinical Trial

Special Drug Use Surveillance for Entresto Tablets

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04781881
Other study ID # CLCZ696B1401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 4, 2021
Est. completion date April 21, 2023

Study information
Verified date May 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 688
Est. completion date April 21, 2023
Est. primary completion date April 21, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Novartis Investigative Site Abashiri Hokkaido
Japan Novartis Investigative Site Adachi Tokyo
Japan Novartis Investigative Site Adachi Tokyo
Japan Novartis Investigative Site Akashi Hyogo
Japan Novartis Investigative Site Akiruno Tokyo
Japan Novartis Investigative Site Awaji Hyogo
Japan Novartis Investigative Site Chikushino-city Fukuka
Japan Novartis Investigative Site Fuchu Hiroshima
Japan Novartis Investigative Site Fujisawa Kanagawa
Japan Novartis Investigative Site Fukagawa Hokkaido
Japan Novartis Investigative Site Funabashi Chiba
Japan Novartis Investigative Site Gifu
Japan Novartis Investigative Site Gotenba Shizuoka
Japan Novartis Investigative Site Hachioji Tokyo
Japan Novartis Investigative Site Hachioji-city Tokyo
Japan Novartis Investigative Site Hakodate Hokkaido
Japan Novartis Investigative Site Hamamatsu Shizuoka
Japan Novartis Investigative Site Higashimatsushima Miyagi
Japan Novartis Investigative Site Higashiohmi Shiga
Japan Novartis Investigative Site Himeji Hyogo
Japan Novartis Investigative Site Himeji Hyogo
Japan Novartis Investigative Site Hiroshima
Japan Novartis Investigative Site Hiroshima
Japan Novartis Investigative Site Hiroshima
Japan Novartis Investigative Site Ichinomiya Aichi
Japan Novartis Investigative Site Ichinomiya Aichi
Japan Novartis Investigative Site Iga Mie
Japan Novartis Investigative Site Iki-city Nagasaki
Japan Novartis Investigative Site Imabari Ehime
Japan Novartis Investigative Site Ishikari Hokkaido
Japan Novartis Investigative Site Iwaki Fukushima
Japan Novartis Investigative Site Iwamizawa Hokkaido
Japan Novartis Investigative Site Kakogawa Hyogo
Japan Novartis Investigative Site Kakogawa-city Hyogo
Japan Novartis Investigative Site Kamakura Kanagawa
Japan Novartis Investigative Site Kanazawa Ishikawa
Japan Novartis Investigative Site Kashiwa Chiba
Japan Novartis Investigative Site Kasuya-gun Fukuoka
Japan Novartis Investigative Site Katsushika Tokyo
Japan Novartis Investigative Site Kawaguchi Saitama
Japan Novartis Investigative Site Kawaguchi Saitama
Japan Novartis Investigative Site Kishima-gun Saga
Japan Novartis Investigative Site Kita-Katsuragi-gun Nara
Japan Novartis Investigative Site Kobe Hyogo
Japan Novartis Investigative Site Kobe Hyogo
Japan Novartis Investigative Site Kobe-city Hyogo
Japan Novartis Investigative Site Kumamoto
Japan Novartis Investigative Site Kumamoto
Japan Novartis Investigative Site Kumamoto
Japan Novartis Investigative Site Kurashiki Okayama
Japan Novartis Investigative Site Kurashiki Okayama
Japan Novartis Investigative Site Kyoto
Japan Novartis Investigative Site Machida Tokyo
Japan Novartis Investigative Site Machida Tokyo
Japan Novartis Investigative Site Machida Tokyo
Japan Novartis Investigative Site Maebashi Gunma
Japan Novartis Investigative Site Matsuyama Ehime
Japan Novartis Investigative Site Mihara Hiroshima
Japan Novartis Investigative Site Minato Tokyo
Japan Novartis Investigative Site Minato-ku Tokyo
Japan Novartis Investigative Site Mito Ibaraki
Japan Novartis Investigative Site Mito Ibaraki
Japan Novartis Investigative Site Morioka Iwate
Japan Novartis Investigative Site Mukou-City Kyoto
Japan Novartis Investigative Site Nagasaki
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Nakano Tokyo
Japan Novartis Investigative Site Nasushiobara Tochigi
Japan Novartis Investigative Site Nishinomiya Hyogo
Japan Novartis Investigative Site Nishio Aichi
Japan Novartis Investigative Site Obu Aichi
Japan Novartis Investigative Site Oita
Japan Novartis Investigative Site Oita
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Ota Tokyo
Japan Novartis Investigative Site Ota Tokyo
Japan Novartis Investigative Site Sagamihara Kanagawa
Japan Novartis Investigative Site Saitama
Japan Novartis Investigative Site Saito Miyazaki
Japan Novartis Investigative Site Sakai Osaka
Japan Novartis Investigative Site Sakata-city Yamagata
Japan Novartis Investigative Site Sakura Chiba
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Sasebo Nagasaki
Japan Novartis Investigative Site Sayama Saitama
Japan Novartis Investigative Site Shimonoseki Yamaguchi
Japan Novartis Investigative Site Shinjo Yamagata
Japan Novartis Investigative Site Shiogama Miyagi
Japan Novartis Investigative Site Shizuoka
Japan Novartis Investigative Site Sunto-gun Shizuoka
Japan Novartis Investigative Site Takamatsu Kagawa
Japan Novartis Investigative Site Takaoka Toyama
Japan Novartis Investigative Site Takarazuka-city Hyogo
Japan Novartis Investigative Site Takarazuka-city Hyogo
Japan Novartis Investigative Site Takasaki Gunma
Japan Novartis Investigative Site Takehara Hiroshima
Japan Novartis Investigative Site Takehara Hiroshima
Japan Novartis Investigative Site Toda Saitama
Japan Novartis Investigative Site Tokorozawa Saitama
Japan Novartis Investigative Site Tokorozawa Saitama
Japan Novartis Investigative Site Tokushima
Japan Novartis Investigative Site Toshima Tokyo
Japan Novartis Investigative Site Toyama
Japan Novartis Investigative Site Tsu-City Mie
Japan Novartis Investigative Site Tsu-city Mie
Japan Novartis Investigative Site Ukiha Fukuoka
Japan Novartis Investigative Site Urasoe Okinawa
Japan Novartis Investigative Site Ureshino Saga
Japan Novartis Investigative Site Utsunomiya Tochigi
Japan Novartis Investigative Site Wakayama
Japan Novartis Investigative Site Watarai Mie
Japan Novartis Investigative Site Yachiyo-city Chiba
Japan Novartis Investigative Site Yamaguchi
Japan Novartis Investigative Site Yatomi Aichi
Japan Novartis Investigative Site Yokohama-city Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety of Entresto in chronic heart failure patients EAIR of hypotension, hyperkalemia, renal impairment and dehydration will be collected.
EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients		 Up to 52 weeks
Secondary To evaluate the impact of risk factors Subgroup analysis of EAIR (patients/100 patient-years) of hypotension, hyperkalemia, renal impairment and dehydration by risk factor will be presented EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients Up to 52 weeks
Secondary To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.
An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Entresto or whose causality is not recorded		 Up to 52 weeks
Secondary EAIR for each of the clinical events EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients Up to 52 weeks
Secondary Kaplan-Meier curve for each of the clinical events Kaplan-Meier estimate of cumulative failure rate(%) will be collected Up to 52 weeks
Secondary Total frequency of hospitalization due to heart failure Total frequency of hospitalization due to heart failure will be collected Up to 52 weeks
Secondary To investigate data on the administration of Entresto in clinical use Data on Entresto administration will be collected Up to 52 weeks
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