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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05976230

Collaborator

(none)

1,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Entresto

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT

Anticipated Study Start Date :

Sep 29, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Entresto Patients administered Entresto by prescription	Drug: 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. Other Names: Entresto Tablets

Arm

Intervention/Treatment

Entresto

Patients administered Entresto by prescription

Drug: 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.

Other Names:

Entresto Tablets

Outcome Measures

Primary Outcome Measures

Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure [Up to 52 weeks]
To investigate the safety of 52 weeks of treatment with Entresto in patients with hypertension in a real-world setting. In particular, the occurrence status of hypotension, hyperkalemia, and renal impairment/renal failure

Secondary Outcome Measures

Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor [Up to 52 weeks]
To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure
Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure [Up to 52 weeks]
To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure
Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time [Up to 52 weeks]
To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting
Percentage of patients who achieved blood pressure control at each evaluation time point [Up to 52 weeks]
To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting
Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point [Up to 52 weeks]
To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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