CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

December 13, 2023 updated by: Novartis Pharmaceuticals

A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Provincia De Salta
      • Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
        • Novartis Investigative Site
      • Innsbruck, Austria, 6020
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1309
        • Novartis Investigative Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Novartis Investigative Site
      • Zagreb, Croatia, 10000
        • Novartis Investigative Site
      • Praha 5, Czechia, 150 06
        • Novartis Investigative Site
      • Helsinki, Finland, 00290
        • Novartis Investigative Site
      • Paris 15, France, 75015
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Stuttgart, Germany, 70174
        • Novartis Investigative Site
      • Budapest, Hungary, H 1096
        • Novartis Investigative Site
      • New Delhi, India, 110029
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, India, 110076
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 060
        • Novartis Investigative Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Novartis Investigative Site
      • Be'er-Sheva, Israel, 84101
        • Novartis Investigative Site
      • Napoli, Italy, 80131
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24127
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20162
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00165
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
      • Saitama, Japan, 330 8777
        • Novartis Investigative Site
    • Aichi
      • Obu, Aichi, Japan, 474 8710
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo city, Hokkaido, Japan, 060 8648
        • Novartis Investigative Site
    • Nagasaki
      • Omura, Nagasaki, Japan, 856-8562
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo ku, Tokyo, Japan, 113 8655
        • Novartis Investigative Site
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • Novartis Investigative Site
      • Shinjuku ku, Tokyo, Japan, 162 8666
        • Novartis Investigative Site
    • Toyama
      • Toyama-city, Toyama, Japan, 930-0194
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03080
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Novartis Investigative Site
    • Gyeongsangnam Do
      • Yangsan Si, Gyeongsangnam Do, Korea, Republic of, 50612
        • Novartis Investigative Site
      • Ashrafieh, Lebanon, 166830
        • Novartis Investigative Site
      • Beirut, Lebanon, 10999
        • Novartis Investigative Site
      • Warszawa, Poland, 04 730
        • Novartis Investigative Site
      • Wroclaw, Poland, 51-124
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000 075
        • Novartis Investigative Site
      • Lisboa, Portugal, 1169 024
        • Novartis Investigative Site
    • Lisboa
      • Carnaxide, Lisboa, Portugal, 2799 523
        • Novartis Investigative Site
      • Moscow, Russian Federation, 125412
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197341
        • Novartis Investigative Site
      • Singapore, Singapore, 119260
        • Novartis Investigative Site
      • Singapore, Singapore, 229899
        • Novartis Investigative Site
    • Gauteng
      • Soweto, Gauteng, South Africa, 2013
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08950
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Novartis Investigative Site
      • Tainan, Taiwan, 70403
        • Novartis Investigative Site
      • Taipei, Taiwan, 10041
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Ankara, Turkey, 06490
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Konak-Izmir, Turkey, 35210
        • Novartis Investigative Site
    • California
      • Loma Linda, California, United States, 92354
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90095
        • Novartis Investigative Site
      • Palo Alto, California, United States, 94304
        • Novartis Investigative Site
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5238
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Novartis Investigative Site
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10032
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

Exclusion Criteria:

  • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2
  • Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit)
  • History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan
  • Renal vascular hypertension (including renal artery stenosis)
  • Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder
  • History of angioedema
  • Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or 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
  • Other protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sacubitril/valsartan
single arm, open label sacubitril/valsartan

Target dose 3.1 mg/kg bid

Formulations:

Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)

Other Names:
  • LCZ696

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Time Frame: to end of study, up to 3 years
Safety. Assessments include: Adverse Events (AEs)
to end of study, up to 3 years
Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability
Time Frame: to end of study, up to 3 years
Safety. Assessments include: Serious Adverse Events (SAEs)
to end of study, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Estimated)

December 29, 2023

Study Completion (Estimated)

December 29, 2023

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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