Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)

Официальное название

Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)

Обзор

This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.

Подробное описание

This specified drug-use survey is conducted to collect information on the safety specifications of Entresto in pediatric patients with chronic heart failure in Japan in actual clinical settings, and to investigate the occurrence of events related to the safety specifications, the risk factors associated with these events, and the status of Entresto administration including the accidental administration of capsule-shaped container (Granules for Pediatric). The subjects of this study are pediatric patients and a long-term observation of 1 year (52 weeks) has been set.

Первичные конечные точки

• Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration [Срок оценки: one year]

Вторичные конечные точки (4)

• Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors [Срок оценки: one year]
• Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric) [Срок оценки: one year]
• Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions [Срок оценки: one year]
• Administration status of Entresto during the observation period [Срок оценки: one year]

Критерии участия

Критерии включения

• Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
• Patients who received Entresto for the first time under the indication of chronic heart failure
• Pediatric patients aged 1 to < 18 years old at the start of treatment with Entresto

Критерии исключения

• Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
• Patients for whom Entresto is contraindicated according to the package insert

• Patients with a history of hypersensitivity to any ingredients of Entresto
• Patients currently under treatment with angiotensin-converting enzyme inhibitors or within 36 hours of discontinuation of treatment with angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, lisinopril hydrate).
• Patients with a history of angioedema (including angioedema due to angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors, hereditary angioedema, acquired angioedema, and idiopathic angioedema etc.)
• Patients with diabetes mellitus under treatment with aliskiren fumarate (excluding patients with markedly poorly controlled blood pressure despite other antihypertensive therapies)
• Patients with severe hepatic impairment (Child-Pugh class C)
• Pregnant women or women who may be pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Япония · 28 центров

• Novartis Investigative Site — Ōbu
• Novartis Investigative Site — Toyoake
• Novartis Investigative Site — Kurume
• Novartis Investigative Site — Kurume
• Novartis Investigative Site — Sapporo
• Novartis Investigative Site — Tsukuba
• Novartis Investigative Site — Kawasaki
• Novartis Investigative Site — Yokohama
• … и ещё 20 центров

Идентификаторы

NCT: NCT06659393 · CLCZ696F1401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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