A Phase 3 interventional study of sacubitril/valsartan in Heart Failure, sponsored by Novartis Pharmaceuticals. Completed at 79 sites in 27 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 216 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single arm, open label sacubitril/valsartan
Drug: 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)
Also known as: LCZ696
Number of Participants With Adverse Events
Number of participants with at least one Adverse Events (AEs)
Time frame: 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)
Time frame: to end of study, up to 4.5 years
Duration of Drug Exposure
Median duration of exposure to sacubitril/valsartan (including temporary interruptions)
Time frame: Up to 4.5 years
79 centers in 27 countries: Korea, Republic of(4), United States(15), Bulgaria(1), Italy(7), Thailand(2), Poland(2), Japan(8), Singapore(2), Israel(1), Turkey(3), Taiwan(2), South Africa(1), Portugal(3), Lebanon(2), Canada(2), Switzerland(1), Czech Republic(1), Croatia(1), Argentina(1), Hungary(1), India(4), Germany(5), France(1), Austria(1), Spain(5), Russia(2), Finland(1)
| Milestone | Age Group 1 | Age Group 2 |
|---|---|---|
| Started | 130 | 86 |
| Safety set (saf) | 130 | 85 |
| Completed | 92 | 74 |
| Not completed | 38 | 12 |
| Withdrew: Adverse event | 16 | 1 |
| Withdrew: Death | 6 | 4 |
| Withdrew: Guardian decision | 4 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 8 | 5 |
| Withdrew: Participant decision | 2 | 0 |
| Withdrew: Other | 1 | 0 |
| Withdrew: No treatment was received | 0 | 1 |
Number of participants with at least one Adverse Events (AEs)
| Participants | Age Group 1 | Age Group 2 |
|---|---|---|
| Number of Participants With Adverse Events | 111 | 78 |
Number of participants with at least one Serious Adverse Events (SAEs)
| Participants | Age Group 1 | Age Group 2 |
|---|---|---|
| Number of Participants With Serious Adverse Events | 59 | 25 |
Median duration of exposure to sacubitril/valsartan (including temporary interruptions)
| Days | Age Group 1 | Age Group 2 |
|---|---|---|
| Duration of Drug Exposure | 894 (23 to 1612) | 951 (62 to 1570) |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 4.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Age Group 1 | 7/130 (5.4%) | 59/130 (45.4%) | 90/130 (69.2%) |
| Age Group 2 | 4/85 (4.7%) | 25/85 (29.4%) | 60/85 (70.6%) |
| Total | 11/215 (5.1%) | 84/215 (39.1%) | 150/215 (69.8%) |
| Event | Age Group 1 | Age Group 2 | Total |
|---|---|---|---|
| Cardiac failureCardiac disorders | 15/130 | 3/85 | 18/215 |
| COVID-19Infections and infestations | 4/130 | 4/85 | 8/215 |
| PneumoniaInfections and infestations | 5/130 | 4/85 | 9/215 |
| Dilated cardiomyopathyCardiac disorders | 5/130 | 0/85 | 5/215 |
| Chest painGeneral disorders | 5/130 | 0/85 | 5/215 |
| PyrexiaGeneral disorders | 3/130 | 3/85 | 6/215 |
| Cardiac failure chronicCardiac disorders | 4/130 | 2/85 | 6/215 |
| GastroenteritisInfections and infestations | 4/130 | 2/85 | 6/215 |
| Cardiac failure acuteCardiac disorders | 2/130 | 2/85 | 4/215 |
| VomitingGastrointestinal disorders | 3/130 | 2/85 | 5/215 |
| Event | Age Group 1 | Age Group 2 | Total |
|---|---|---|---|
| COVID-19Infections and infestations | 23/130 | 24/85 | 47/215 |
| PyrexiaGeneral disorders | 15/130 | 22/85 | 37/215 |
| Upper respiratory tract infectionInfections and infestations | 8/130 | 22/85 | 30/215 |
| CoughRespiratory, thoracic and mediastinal disorders | 20/130 | 19/85 | 39/215 |
| NasopharyngitisInfections and infestations | 12/130 | 14/85 | 26/215 |
| VomitingGastrointestinal disorders | 15/130 | 12/85 | 27/215 |
| HypotensionVascular disorders | 18/130 | 3/85 | 21/215 |
| HeadacheNervous system disorders | 15/130 | 3/85 | 18/215 |
| DizzinessNervous system disorders | 14/130 | 0/85 | 14/215 |
| DiarrhoeaGastrointestinal disorders | 9/130 | 9/85 | 18/215 |
Baseline Participants are based on the Safety Set (SAF) population, as primary analysis are based on the SAF.
| Age, Continuous(Years) | Age Group 1 | Age Group 2 | Total |
|---|---|---|---|
| Mean | 12.83 ± 3.864 | 2.94 ± 1.149 | 8.92 ± 5.747 |
| Sex: Female, Male(Participants) | Age Group 1 | Age Group 2 | Total |
|---|---|---|---|
| Female | 60 | 49 | 109 |
| Male | 70 | 36 | 106 |
| Race/Ethnicity, Customized(Participants) | Age Group 1 | Age Group 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| White | 78 | 41 | 119 |
| Asian | 24 | 23 | 47 |
| Black or African American | 19 | 10 | 29 |
| Multiple | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Unknown | 7 | 6 | 13 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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