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

NCT03785405 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLCZ696B2319E1
• Study Type: interventional
• Target: 216
• Locations: 27 countries
• Sites: 79

Brief 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.

Conditions

Heart Failure

Keywords

heart failure; pediatric; LCZ696; sacubitril/valsartan; open-label study; angiotensin receptor neprilysin inhibitor; PANORAMA-HF

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events

  Number of participants with at least one Adverse Events (AEs)

  to end of study, up to 4,5 years

• Number of Participants With Serious Adverse Events

  Number of participants with at least one Serious Adverse Events (SAEs)

  to end of study, up to 4.5 years

• Duration of Drug Exposure

  Median duration of exposure to sacubitril/valsartan (including temporary interruptions)

  Up to 4.5 years

Study Arms (1)

sacubitril/valsartan

EXPERIMENTAL

single arm, open label sacubitril/valsartan

Drug: sacubitril/valsartan

Interventions

sacubitril/valsartan DRUG

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)

Also known as: LCZ696

sacubitril/valsartan

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (79)

Novartis Investigative Site

Loma Linda, California, 92354, United States

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Novartis Investigative Site

Los Angeles, California, 90095, United States

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Novartis Investigative Site

Palo Alto, California, 94304, United States

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Novartis Investigative Site

St. Petersburg, Florida, 33701, United States

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Novartis Investigative Site

Atlanta, Georgia, 30322, United States

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Novartis Investigative Site

Indianapolis, Indiana, 46202, United States

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Novartis Investigative Site

Boston, Massachusetts, 02115, United States

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Novartis Investigative Site

Ann Arbor, Michigan, 48109-5238, United States

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Novartis Investigative Site

Minneapolis, Minnesota, 55455, United States

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Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

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Novartis Investigative Site

St Louis, Missouri, 63110, United States

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Novartis Investigative Site

New York, New York, 10032, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28203, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, 19104, United States

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Novartis Investigative Site

Pittsburgh, Pennsylvania, 15224, United States

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Novartis Investigative Site

Salta, Salta Province, A4406BPF, Argentina

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Novartis Investigative Site

Innsbruck, 6020, Austria

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Novartis Investigative Site

Sofia, 1309, Bulgaria

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Novartis Investigative Site

Edmonton, Alberta, T6G 1C9, Canada

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Novartis Investigative Site

Toronto, Ontario, M5G 1X8, Canada

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Novartis Investigative Site

Zagreb, 10000, Croatia

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Novartis Investigative Site

Prague, 150 06, Czechia

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Novartis Investigative Site

Helsinki, 00290, Finland

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Novartis Investigative Site

Paris, 75015, France

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

Stuttgart, 70174, Germany

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Novartis Investigative Site

Budapest, H 1096, Hungary

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Novartis Investigative Site

Ahmedabad, Gujarat, 380 060, India

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Novartis Investigative Site

Kochi, Kerala, 682041, India

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Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110076, India

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Novartis Investigative Site

New Delhi, 110029, India

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Novartis Investigative Site

Beersheba, 84101, Israel

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Novartis Investigative Site

Bergamo, BG, 24127, Italy

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Florence, FI, 50132, Italy

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Novartis Investigative Site

Milan, MI, 20162, Italy

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Novartis Investigative Site

Roma, RM, 00165, Italy

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Novartis Investigative Site

Torino, TO, 10126, Italy

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Novartis Investigative Site

Napoli, 80131, Italy

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Novartis Investigative Site

Ōbu, Aichi-ken, 474 8710, Japan

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Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

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Novartis Investigative Site

Ōmura, Nagasaki, 856-8562, Japan

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Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

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Novartis Investigative Site

Setagaya-ku, Tokyo, 157-8535, Japan

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Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8666, Japan

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Novartis Investigative Site

Toyama, Toyama, 930-0194, Japan

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Novartis Investigative Site

Saitama, 330 8777, Japan

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Novartis Investigative Site

Beirut, 10999, Lebanon

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Novartis Investigative Site

El Achrafiyé, 166830, Lebanon

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Novartis Investigative Site

Warsaw, 04 730, Poland

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Novartis Investigative Site

Wroclaw, 51-124, Poland

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Novartis Investigative Site

Carnaxide, Lisbon District, 2799 523, Portugal

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Novartis Investigative Site

Coimbra, 3000 075, Portugal

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Novartis Investigative Site

Lisbon, 1169 024, Portugal

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Novartis Investigative Site

Moscow, 125412, Russia

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Novartis Investigative Site

Saint Petersburg, 197341, Russia

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Novartis Investigative Site

Singapore, 119260, Singapore

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Novartis Investigative Site

Singapore, 229899, Singapore

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Novartis Investigative Site

Soweto, Gauteng, 2013, South Africa

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Novartis Investigative Site

Yangsan, Gyeongsangnam-do, 50612, South Korea

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Novartis Investigative Site

Seoul, 03080, South Korea

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Novartis Investigative Site

Seoul, 03722, South Korea

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Novartis Investigative Site

Seoul, 06351, South Korea

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Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

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Novartis Investigative Site

Esplugues de Llobregat, Barcelona, 08950, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

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Novartis Investigative Site

Madrid, 28009, Spain

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Novartis Investigative Site

Madrid, 28046, Spain

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Novartis Investigative Site

Lausanne, 1011, Switzerland

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Novartis Investigative Site

Tainan, 70403, Taiwan

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Novartis Investigative Site

Taipei, 10041, Taiwan

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Novartis Investigative Site

Bangkoknoi, Bangkok, 10700, Thailand

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Novartis Investigative Site

Bangkok, 10400, Thailand

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Novartis Investigative Site

Ankara, 06490, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35040, Turkey (Türkiye)

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Novartis Investigative Site

Konak-Izmir, 35210, Turkey (Türkiye)

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: December 20, 2018
• First Posted: December 24, 2018
• Study Start: May 2, 2019
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: May 16, 2025
• Results First Posted: July 16, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

BU (1); IT (7); ZA (1); DE (5); FR (1); TH (2); JP (8); TW (2); FI (1); CZ (1); PT (3); TU (3); AR (1); US (15); CR (1); CH (1); IN (4); ES (5); SG (2); AU (1); RU (2); PL (2); KR (4); IL (1); HU (1); LE (2); CA (2)