Status:
COMPLETED
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18-99 years
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 confi...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients with a history or complication of cardiac failure
- Patients who have been hospitalized at the start of treatment with Entresto
Key Trial Info
Start Date :
September 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
1125 Patients enrolled
Trial Details
Trial ID
NCT05976230
Start Date
September 4 2023
End Date
May 29 2025
Last Update
July 3 2025
Active Locations (117)
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1
Novartis Investigative Site
Anjo, Aichi-ken, Japan, 444-1154
2
Novartis Investigative Site
Ichinomiya, Aichi-ken, Japan, 494-0001
3
Novartis Investigative Site
Kasugai, Aichi-ken, Japan, 487-0024
4
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 460-0004