Special Drug Use Surveillance of Entresto Tablets (Hypertension) (ENLIGHT)

Novartis

Status: Completed

Conditions: Hypertension

Treatments: Drug: Entresto

Study type: Observational

Funder types: Industry

Identifiers

NCT05976230

CLCZ696A1402

Details and patient eligibility

About

This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.

Full description

This study is a special drug use surveillance to collect information on the safety specifications under the actual clinical practice of Entresto Tablets in patients with hypertension in Japan to confirm the occurrence and timing of onset of events related to the safety specifications and investigate their risk factors.

Enrollment: 1,125 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have given written consent to participate in this study before the start of treatment with Entresto
2. Patients who used Entresto for the first time for the indication of hypertension

Exclusion criteria

1. Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug)

2. The following patients for whom administration of Entresto is contraindicated in the package insert:

   • Patients with a history of hypersensitivity to any of the ingredients of Entresto
   • Patients who are receiving angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, and lisinopril hydrate) or who discontinued these drugs within 36 hours.
   • Patients with a history of angioedema (angioedema due to angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.)
   • Patients with diabetes mellitus who are receiving aliskiren fumarate
   • Patients with severe hepatic impairment (Child-Pugh class C)
   • Pregnant or possibly pregnant women

3. Patients with a history or complication of cardiac failure

4. Patients who have been hospitalized at the start of treatment with Entresto

Trial design

1,125 participants in 1 patient group

Entresto

Description:

Patients administered Entresto by prescription

Treatment:

Drug: Entresto