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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Hyponatremia

Heart Failure

Treatment

N/A

Clinical Study ID

NCT06659393
CLCZ696F1401
  • Ages 1-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria

  1. Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.

  2. Patients who received Entresto for the first time under the indication of chronic heart failure

  3. Pediatric patients aged 1 to < 18 years old at the start of treatment with Entresto

Exclusion criteria

  1. Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)

  2. 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

Study Design

Total Participants: 33
Study Start date:
December 19, 2024
Estimated Completion Date:
November 30, 2027

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Kawasaki, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Yokohama-city, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Omura, Nagasaki 856-8562
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fuchu-city, Tokyo 183-8561
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 157-8535
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyama, 930-0194
    Japan

    Active - Recruiting

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