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

Last updated: May 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

sacubitril/valsartan

Clinical Study ID

NCT03785405
CLCZ696B2319E1
  • Ages 1-18
  • All Genders

Study Summary

The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2 as per protocol.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safetyissue

Exclusion

Exclusion Criteria:

  • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF orpermanently 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-hourwashout before baseline visit)

  • History of hypersensitivity or allergy to study treatment, its excipients or drugsof similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspectedcontraindications to sacubitril/valsartan

  • Renal vascular hypertension (including renal artery stenosis)

  • Significant renal estimated glomerular filtration rate disorder (eGFR calculatedusing modified Schwartz formula <30% mean GFR for age); hepatic disorder (serumaspartate aminotransferase or alanine aminotransferase > 3 times upper limit ofnormal); gastrointestinal disorder or biliary disorder

  • History of angioedema

  • Parents or legal guardians of subject who do not give consent or allow the child togive assent, or inability of patient or 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

  • Other protocol defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: sacubitril/valsartan
Phase: 3
Study Start date:
May 02, 2019
Estimated Completion Date:
December 29, 2023

Study Description

This was a multicenter, open-label long-term extension study for participants who successfully completed PANORAMA-HF core study Part 2 of the trial or who discontinued study drug treatment early in Part 2 due to the implementation of Urgent safety measure (USM) of PANORAMA-HF core study. Provided that they fulfilled the protocol requirements, these patients were eligible to participate in the OLE. Depending on when and where the participant was enrolled, the duration of the study was of a minimum of 1 year, or until receipt of local marketing authorization and commercial availability, or reaching the maximum limit allowed by local regulations, or until Dec-2023, whichever occurred first.

Connect with a study center

  • Novartis Investigative Site

    Ciudad de Salta, Provincia De Salta A4406BPF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1309
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Zagreb, 10000
    Croatia

    Site Not Available

  • Novartis Investigative Site

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Helsinki, 00290
    Finland

    Site Not Available

  • Novartis Investigative Site

    Paris, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Paris 15, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Paris cedex 15, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart, 70174
    Germany

    Site Not Available

  • Novartis Investigative Site

    Budapest, H 1096
    Hungary

    Site Not Available

  • Novartis Investigative Site

    New Delhi, Delhi 110076
    India

    Site Not Available

  • Novartis Investigative Site

    Ahmedabad, Gujarat 380 060
    India

    Site Not Available

  • Novartis Investigative Site

    Kochi, Kerala 682041
    India

    Site Not Available

  • Novartis Investigative Site

    Be'er-Sheva, 84101
    Israel

    Site Not Available

  • Novartis Investigative Site

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Novartis Investigative Site

    Bergamo, BG 24127
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bologna, BO 40138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Firenze, FI 50132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20162
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 00165
    Italy

    Site Not Available

  • Novartis Investigative Site

    Torino, TO 10126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli, 80131
    Italy

    Site Not Available

  • Novartis Investigative Site

    Obu, Aichi 474 8710
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo city, Hokkaido 060 8648
    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

    Shinjuku ku, Tokyo 162 8666
    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

    Yangsan Si, Gyeongsangnam Do 50612
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Beirut, 10999
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Warszawa, 04 730
    Poland

    Site Not Available

  • Novartis Investigative Site

    Wroclaw, 51-124
    Poland

    Site Not Available

  • Novartis Investigative Site

    Carnaxide, Lisboa 2799 523
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Coimbra, 3000 075
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Lisboa, 1169 024
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Moscow, 125412
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Singapore, 229899
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Cordoba, Andalucia 14004
    Spain

    Site Not Available

  • Novartis Investigative Site

    Esplugues De Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Tainan, 70403
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10041
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Bangkoknoi, Bangkok 10700
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 10400
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Ankara, 06490
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Izmir, 35040
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Konak-Izmir, 35210
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Konak/Izmir, 35210
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Loma Linda, California 92354
    United States

    Site Not Available

  • Novartis Investigative Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Novartis Investigative Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Novartis Investigative Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • All Childrens Hospital

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Childrens Healthcare Of Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Novartis Investigative Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Childrens Hospital Boston CAFQ056B2252

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • CS Mott Children's Hospital CLCZ696B2319

    Ann Arbor, Michigan 48109-5238
    United States

    Site Not Available

  • Novartis Investigative Site

    Ann Arbor, Michigan 48109-5238
    United States

    Site Not Available

  • Novartis Investigative Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota Cardiovascular Clinical Trials Ctr CLCZ696B2319

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Novartis Investigative Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Novartis Investigative Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Col Uni Med Center New York Presby CDEB025A2306

    New York, New York 10032
    United States

    Site Not Available

  • Novartis Investigative Site

    New York, New York 10032
    United States

    Site Not Available

  • Novartis Investigative Site

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

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