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

NCT06149104 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLCZ696B2319E2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 6

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.

Conditions

Heart Failure

Keywords

sacubitril/valsartan; post-trial access; pediatric; heart failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.

  Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.

Study Arms (1)

sacubitril/valsartan

EXPERIMENTAL

The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.

Drug: sacubitril/valsartan

Interventions

sacubitril/valsartan DRUG

sacubiril/valsartan

sacubitril/valsartan

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent
• \<18 years of age (at the time of signing informed consent)
• Completed CLCZ696B2319E1 study and safely enrolled

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Ōbu, Aichi-ken, 474 8710, Japan

Location

Novartis Investigative Site

Ōmura, Nagasaki, 856-8562, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

Location

Novartis Investigative Site

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Novartis Investigative Site

Saitama, 330 8777, Japan

Location

Novartis Investigative Site

Toyama, 930-0194, Japan

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 28, 2023
• Study Start: December 4, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: October 14, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)