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Post-marketing Surveillance Protocol Number;CLCZ696A1402

Special drug use surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT2031230283
Enrollment
1000
Registered
2023-08-09
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

None listed

Sponsors

Sugigmoto Toshiya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients with hypotension, hyperkalemia, and renal impairment/failur

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026