Clinical trial NCT06149104: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: sacubitril/valsartan
post-trial access
pediatric
heart failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This trial (CLCZ696B2319E2) was a multicenter, open-label extension study for Japanese patients who have successfully completed the CLCZ696B2319E1 study. Only Japanese patients who successfully completed CLCZ696B2319E1 study and fulfilled protocol requirements were eligible to participate in this study.

The first visit (Visit Day1) was the same day as the End of Study visit of CLCZ696B2319E1 study.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Obu
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Omura
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: