NCT06149104CompletedPhase 3
A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
A Multicenter, Open-label Study to Collect the Safety Information of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
Source: ClinicalTrials.gov · Last updated 14 Oct 2025
Brief summary (registry, in English)
The purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1(NCT03785405) study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 13 Nov 2023
- Start date
- 4 Dec 2023
- Primary completion date
- 14 Aug 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Heart failure
- NCT number
- NCT06149104
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 8
- From 4 Dec 2023 to the primary completion date, 14 Aug 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Renal vascular hypertension (including renal artery stenosis)
- History of angioedema
- 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
Other
- Permanently discontinued the study treatment during CLCZ696B2319E1 study
- 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
Who the study is looking for
- Signed informed consent
- \<18 years of age (at the time of signing informed consent)
- Completed CLCZ696B2319E1 study and safely enrolled
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ōbu | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ōmura | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Setagaya-ku | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.