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Clinical trial

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

ID
Name
CLCZ696B1401
Description
This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.
Trial arms
Trial start
2021-03-04
Estimated PCD
2023-04-21
Trial end
2023-04-21
Status
Completed
Treatment
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.
Arms:
Entresto
Size
688
Primary endpoint
To evaluate the safety of Entresto in chronic heart failure patients
Up to 52 weeks
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 688, 'type': 'ACTUAL'}}
Updated at
2023-05-06

1 organization

1 product

1 indication

Organization
Novartis Pharmaceuticals
Product
Entresto
Indication
Chronic Heart Failure