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

April 7, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novartis Pharmaceuticals

Study Contact Backup

Study Locations

  • Japan
      • Akita, Japan, 010-8543
        • Recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 8128582
        • Active, not recruiting
        • Novartis Investigative Site
      • Kumamoto, Japan, 862-8505
        • Completed
        • Novartis Investigative Site
      • Okayama, Japan, 7008558
        • Recruiting
        • Novartis Investigative Site
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 4701192
        • Recruiting
        • Novartis Investigative Site
      • Ōbu, Aichi-ken, Japan, 474 8710
        • Recruiting
        • Novartis Investigative Site
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Novartis Investigative Site
      • Kurume, Fukuoka, Japan, 830-8543
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Novartis Investigative Site
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 3058576
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 2168511
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa-ku
      • Yokohama, Kanagawa-ku, Japan, 236-0004
        • Recruiting
        • Novartis Investigative Site
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Novartis Investigative Site
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Recruiting
        • Novartis Investigative Site
      • Ōmura, Nagasaki, Japan, 856-8562
        • Recruiting
        • Novartis Investigative Site
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Novartis Investigative Site
      • Saitama, Saitama, Japan, 330-8777
        • Recruiting
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8558
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 1138431
        • Recruiting
        • Novartis Investigative Site
      • Bunkyo Ku, Tokyo, Japan, 113-8655
        • Recruiting
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Novartis Investigative Site
      • Fuchū, Tokyo, Japan, 183-0003
        • Recruiting
        • Novartis Investigative Site
      • Fuchū, Tokyo, Japan, 1838561
        • Recruiting
        • Novartis Investigative Site
      • Setagaya-ku, Tokyo, Japan, 1578535
        • Recruiting
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 1428666
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 1628666
        • Recruiting
        • Novartis Investigative Site
      • Ōta-ku, Tokyo, Japan, 143 8541
        • Recruiting
        • Novartis Investigative Site
    • Toyama
      • Toyama, Toyama, Japan, 9300194
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration
Time Frame: one year
To confirm the occurrence status up to 52 weeks of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications of Entresto administration in pediatric patients with chronic heart failure in actual clinical settings.
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors
Time Frame: one year
To investigate the impact of risk factors on the occurrence of hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications.
one year
Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)
Time Frame: one year
To confirm the occurrence status of the accidental administration of the capsule-shaped container (Granules for Pediatric).
one year
Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions
Time Frame: one year
To confirm the occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions.
one year
Administration status of Entresto during the observation period
Time Frame: one year
To confirm the administration status of Entresto used in actual clinical settings.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLCZ696F1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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