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Open-label Extension Study to...

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

Last Updated: 2025-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2023-12-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sacubitril/valsartan

single arm, open label sacubitril/valsartan

Group Type EXPERIMENTAL

sacubitril/valsartan

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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LCZ696

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Seoul, , South Korea

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Novartis Investigative Site

Seoul, , South Korea

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Novartis Investigative Site

Córdoba, Andalusia, Spain

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Esplugues de Llobregat, Barcelona, Spain

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Novartis Investigative Site

Barcelona, Catalonia, Spain

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Novartis Investigative Site

Loma Linda, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Indianapolis, Indiana, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Mayo Clinic - Rochester

Rochester, Minnesota, United States

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Novartis Investigative Site

St Louis, Missouri, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Salta, Salta Province, Argentina

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Innsbruck, , Austria

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Sofia, , Bulgaria

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Zagreb, , Croatia

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Prague, , Czechia

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Helsinki, , Finland

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Paris, , France

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Berlin, , Germany

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Erlangen, , Germany

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Freiburg im Breisgau, , Germany

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Heidelberg, , Germany

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Stuttgart, , Germany

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Budapest, , Hungary

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Ahmedabad, Gujarat, India

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Kochi, Kerala, India

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New Delhi, National Capital Territory of Delhi, India

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New Delhi, , India

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Beersheba, , Israel

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Bergamo, BG, Italy

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Bologna, BO, Italy

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Florence, FI, Italy

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Milan, MI, Italy

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Roma, RM, Italy

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Torino, TO, Italy

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Napoli, , Italy

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Ōbu, Aichi-ken, Japan

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Sapporo, Hokkaido, Japan

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Ōmura, Nagasaki, Japan

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Bunkyo Ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Toyama, Toyama, Japan

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Saitama, , Japan

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Beirut, , Lebanon

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El Achrafiyé, , Lebanon

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Warsaw, , Poland

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Wroclaw, , Poland

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Carnaxide, Lisbon District, Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Moscow, , Russia

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Saint Petersburg, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Soweto, Gauteng, South Africa

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Yangsan, Gyeongsangnam-do, South Korea

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Seoul, , South Korea

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Madrid, , Spain

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Madrid, , Spain

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Lausanne, , Switzerland

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Bangkoknoi, Bangkok, Thailand

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Bangkok, , Thailand

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Ankara, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Konak-Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Austria Bulgaria Canada Croatia Czechia Finland France Germany Hungary India Israel Italy Japan Lebanon Poland Portugal Russia Singapore South Africa South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye)