Special Drug Use Surveillance of Entresto Tablets (Hypertension)

Launched by NOVARTIS PHARMACEUTICALS · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of Entresto Tablets, a medication used to treat high blood pressure (hypertension), in Japanese patients over a period of 52 weeks. The trial is currently active but not recruiting new participants. It is designed for adults between the ages of 65 and 74 who are starting treatment with Entresto for the first time and have given their written consent to participate.

To be eligible for the study, participants cannot have taken Entresto or any similar medication before. There are also certain health conditions that would exclude someone from participating, such as a history of severe allergic reactions to the medication, specific heart problems, or being pregnant. Those who join the trial can expect regular check-ins to monitor their health and how well the medication is working for them. This study aims to gather important information that could help improve treatment for patients with high blood pressure in the future.

Gender

ALL

Eligibility 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:
• • 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