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

Last updated: January 27, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

sacubitril/valsartan

Clinical Study ID

NCT06149104
CLCZ696B2319E2
  • Ages 3-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • <18 years of age (at the time of signing informed consent)

  • Completed CLCZ696B2319E1 study and safely enrolled

Exclusion

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 giveassent, or inability of patient or the parents/legal guardians to followinstructions or comply with follow-up procedures

  • Any medical condition(s) that may put the patient at risk in the Investigator'sopinion or that the Investigator deems unsuitable for the study

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: sacubitril/valsartan
Phase: 3
Study Start date:
December 04, 2023
Estimated Completion Date:
August 14, 2024

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Obu, Aichi 474 8710
    Japan

    Site Not Available

  • Novartis Investigative Site

    Omura, Nagasaki 856-8562
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113 8655
    Japan

    Site Not Available

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 157-8535
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyama-city, Toyama 930-0194
    Japan

    Site Not Available

  • Novartis Investigative Site

    Saitama, 330 8777
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyama, 930-0194
    Japan

    Site Not Available

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