Special Drug Use Surveillance for Entresto Tablets

  • End date
    Oct 31, 2023
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 19 September 2021


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


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.

Condition Chronic Heart Failure
Treatment Entresto
Clinical Study IdentifierNCT04781881
SponsorNovartis Pharmaceuticals
Last Modified on19 September 2021


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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
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