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NCT06149104 | COMPLETED | Heart Failure

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
Sponsor:

Novartis Pharmaceuticals

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.

Condition or disease

Heart Failure

Intervention/treatment

sacubitril/valsartan

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 8 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-12-04
Estimated Primary Completion Date : 2024-08-14
Estimated Study Completion Date : 2024-08-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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

Location Details

NCT06149104

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Japan, Aichi

Novartis Investigative Site

Obu, Aichi, Japan, 474 8710

Not yet recruiting

Japan, Nagasaki

Novartis Investigative Site

Omura, Nagasaki, Japan, 856-8562

Not yet recruiting

Japan, Tokyo

Novartis Investigative Site

Commentary, Tokyo, Japan, 113 8655

Not yet recruiting

Japan, Tokyo

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan, 157-8535

Not yet recruiting

Japan,

Novartis Investigative Site

Saatma, Japan, 330 8777

Not yet recruiting

Japan,

Novartis Investigative Site

Toyama, Japan, 930-0194