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Heart drug safety trial in kids: small but important step

NCT ID NCT06149104

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the safety of the drug sacubitril/valsartan in Japanese children with heart failure. Eight children who had already been in a previous trial took the drug to see if any side effects occurred. The goal was to gather more safety information and provide the drug until a child-friendly version becomes available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacubitril/valsartan
What this could lead to
If successful, this could confirm that sacubitril/valsartan is safe for Japanese children with heart failure, supporting its use as a treatment option.
What could go wrong
This is a very small study (8 participants) focused only on safety, not effectiveness. It may not detect rare side effects or apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

8 people

The number who actually took part.

Started

Dec 2023

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent * \<18 years of age (at the time of signing informed consent) * Completed CLCZ696B2319E1 study and safely enrolled Exclusion Criteria: * Permanently discontinued the study treatment during CLCZ696B2319E1 study * Renal vascular hypertension (including renal artery stenosis) * History of angioedema * Having parents or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the parents/legal guardians to follow instructions or comply with follow-up procedures * Any medical condition(s) that may put the patient at risk in the Investigator's opinion or that the Investigator deems unsuitable for the study

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Novartis Investigative Site

    Ōbu, Aichi-ken, 474 8710, Japan

  • Novartis Investigative Site

    Ōmura, Nagasaki, 856-8562, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113 8655, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 157-8535, Japan

  • Novartis Investigative Site

    Saitama, 330 8777, Japan

  • Novartis Investigative Site

    Toyama, 930-0194, Japan

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