Heart FailurePhase 3NCT03785405
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
A Phase 3 study testing sacubitril/valsartan in people with Heart Failure, run by Novartis Pharmaceuticals at 79 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- sacubitril/valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 79 sitesin 27 countries
- Study dates
- 2 May 2019to 29 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
79 sites in 27 countries.
79 sites in 27 countries
United States15 sites
Novartis Investigative Site
Ann Arbor, Michigan, 48109-5238
Novartis Investigative Site
Atlanta, Georgia, 30322
Novartis Investigative Site
Boston, Massachusetts, 02115
Novartis Investigative Site
Charlotte, North Carolina, 28203
Novartis Investigative Site
Indianapolis, Indiana, 46202
Novartis Investigative Site
Loma Linda, California, 92354
Novartis Investigative Site
Los Angeles, California, 90095
Novartis Investigative Site
Minneapolis, Minnesota, 55455
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
Palo Alto, California, 94304
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15224
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
St. Petersburg, Florida, 33701
Japan8 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113 8655
Novartis Investigative Site
Ōbu, Aichi-ken, 474 8710
Novartis Investigative Site
Ōmura, Nagasaki, 856-8562
Novartis Investigative Site
Saitama, 330 8777
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648
Novartis Investigative Site
Setagaya-ku, Tokyo, 157-8535
Novartis Investigative Site
Shinjuku Ku, Tokyo, 162 8666
Novartis Investigative Site
Toyama, Toyama, 930-0194
Italy7 sites
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Florence, FI, 50132
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, RM, 00165
Novartis Investigative Site
Torino, TO, 10126
Germany5 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Stuttgart, 70174
Spain5 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
Esplugues de Llobregat, Barcelona, 08950
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28046
India4 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380 060
Novartis Investigative Site
Kochi, Kerala, 682041
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110076
Novartis Investigative Site
New Delhi, 110029
South Korea4 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 06351
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, 50612
Portugal3 sites
Novartis Investigative Site
Carnaxide, Lisbon District, 2799 523
Novartis Investigative Site
Coimbra, 3000 075
Novartis Investigative Site
Lisbon, 1169 024
Turkey (Türkiye)3 sites
Novartis Investigative Site
Ankara, 06490
Novartis Investigative Site
Izmir, 35040
Novartis Investigative Site
Konak-Izmir, 35210
Canada2 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1C9
Novartis Investigative Site
Toronto, Ontario, M5G 1X8
Lebanon2 sites
Novartis Investigative Site
Beirut, 10999
Novartis Investigative Site
El Achrafiyé, 166830
Poland2 sites
Novartis Investigative Site
Warsaw, 04 730
Novartis Investigative Site
Wroclaw, 51-124
Russia2 sites
Novartis Investigative Site
Moscow, 125412
Novartis Investigative Site
Saint Petersburg, 197341
Singapore2 sites
Novartis Investigative Site
Singapore, 119260
Novartis Investigative Site
Singapore, 229899
Taiwan2 sites
Novartis Investigative Site
Tainan, 70403
Novartis Investigative Site
Taipei, 10041
Thailand2 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkoknoi, Bangkok, 10700
About this study
Official title: 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 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.
Read the detailed 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.
- Conditions
- Heart Failure
- Being tested
- sacubitril/valsartan
- Keywords
- heart failure, pediatric, LCZ696, sacubitril/valsartan, open-label study, angiotensin receptor neprilysin inhibitor, PANORAMA-HF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/valsartanDrug
Also called LCZ696
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)
| Study group | Role | What they receive |
|---|---|---|
| sacubitril/valsartan | Experimental | single arm, open label sacubitril/valsartan Receives: Drug: sacubitril/valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants with at least one Adverse Events (AEs)
Measured: 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)
Measured: to end of study, up to 4.5 years
Duration of Drug Exposure
Median duration of exposure to sacubitril/valsartan (including temporary interruptions)
Measured: Up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start2 May 2019
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785405
- Sponsor's protocol ID
- CLCZ696B2319E1
- Status last verified
- May 2025
- First submitted
- 20 Dec 2018
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03785405
- Acronym / sponsor ID
- CLCZ696B2319E1
- Conditions
- Heart Failure
- Keywords
- heart failure, pediatric, LCZ696, sacubitril/valsartan, open-label study, angiotensin receptor neprilysin inhibitor, PANORAMA-HF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacubitril/valsartan | Experimental | Drug: sacubitril/valsartansingle arm, open label sacubitril/valsartan |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Signed informed consent
- On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/valsartanAlso: LCZ696Target 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) | Drug | sacubitril/valsartan |
Primary outcome
Number of Participants With Adverse Events
Time frame: to end of study, up to 4,5 years
Number of participants with at least one Adverse Events (AEs)
Number of Participants With Serious Adverse Events
Time frame: to end of study, up to 4.5 years
Number of participants with at least one Serious Adverse Events (SAEs)
Duration of Drug Exposure
Time frame: Up to 4.5 years
Median duration of exposure to sacubitril/valsartan (including temporary interruptions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
79 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sacubitril/valsartan in people with Heart Failure, run by Novartis Pharmaceuticals at 79 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Japan, Italy, Germany, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: to end of study, up to 4,5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.