Special Drug Use Surveillance for Entresto Tablets

Novartis

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Drug: Entresto

Study type: Observational

Funder types: Industry

Identifiers

NCT04781881

CLCZ696B1401

Details and patient eligibility

About

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

Full 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.

Enrollment: 688 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

688 participants in 1 patient group

Entresto

Description:

Patients administered Entresto by prescription

Treatment:

Drug: Entresto