Special Drug Use Surveillance of Entresto Tablets (Hypertension)

Active, not recruiting

• Conditions: Hypertension
• Interventions: Drug: Entresto

• Registration Number: NCT05976230
• Lead Sponsor: Novartis Pharmaceuticals

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.

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 Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-04
• Study Start: 2023-09-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Entresto	Entresto	Patients administered Entresto by prescription

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Yamaguchi, Japan