Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)
Recruiting · NCT06659393 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
1 Year to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
28 locations listed.
- Novartis Investigative Site - Akita, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Kumamoto, Japan
- Novartis Investigative Site - Okayama, Japan
- Novartis Investigative Site - Toyoake, Aichi-ken, Japan
- Novartis Investigative Site - Ōbu, Aichi-ken, Japan
- Novartis Investigative Site - Kurume, Fukuoka, Japan
- Novartis Investigative Site - Kurume, Fukuoka, Japan
- Novartis Investigative Site - Sapporo, Hokkaido, Japan
- Novartis Investigative Site - Tsukuba, Ibaraki, Japan
- Novartis Investigative Site - Kawasaki, Kanagawa, Japan
- Novartis Investigative Site - Yokohama, Kanagawa-ku, Japan
- Novartis Investigative Site - Tsu, Mie-ken, Japan
- Novartis Investigative Site - Nagasaki, Nagasaki, Japan
- Novartis Investigative Site - Ōmura, Nagasaki, Japan
- Novartis Investigative Site - Hidaka, Saitama, Japan
- Novartis Investigative Site - Saitama, Saitama, Japan
- Novartis Investigative Site - Hamamatsu, Shizuoka, Japan
- Novartis Investigative Site - Bunkyo Ku, Tokyo, Japan
- Novartis Investigative Site - Bunkyo Ku, Tokyo, Japan
- Novartis Investigative Site - Bunkyo-ku, Tokyo, Japan
- Novartis Investigative Site - Fuchū, Tokyo, Japan
- Novartis Investigative Site - Fuchū, Tokyo, Japan
- Novartis Investigative Site - Setagaya-ku, Tokyo, Japan
- Novartis Investigative Site - Shinagawa-ku, Tokyo, Japan
- Novartis Investigative Site - Shinjuku Ku, Tokyo, Japan
- Novartis Investigative Site - Ōta-ku, Tokyo, Japan
- Novartis Investigative Site - Toyama, Toyama, Japan