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The purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1(NCT03785405) study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.
This trial (CLCZ696B2319E2) was a multicenter, open-label extension study for Japanese patients who have successfully completed the CLCZ696B2319E1 study. Only Japanese patients who successfully completed CLCZ696B2319E1 study and fulfilled protocol requirements were eligible to participate in this study.
The first visit (Visit Day1) was the same day as the End of Study visit of CLCZ696B2319E1 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sacubitril/valsartan | Experimental | The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacubitril/valsartan | Drug | sacubiril/valsartan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs. | Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | ÅŒbu | Aichi-ken | 474 8710 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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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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All consenting participants were assessed for eligibility into this study at the first visit (Visit Day 1) and the study medication was initiated.
Participants took part in 6 investigative sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sacubitril/Valsartan | The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. All participants had a target dose of 3.1 mg/kg bid. If a participant was unable to tolerate up-titration to a higher sacubitril/valsartan dose level or at the discretion of the Investigator, participants could be maintained on lower dose levels of sacubitril/valsartan. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2023 | Jan 27, 2025 |
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| ÅŒmura |
| Nagasaki |
| 856-8562 |
| Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113 8655 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Novartis Investigative Site | Saitama | 330 8777 | Japan |
| Novartis Investigative Site | Toyama | 930-0194 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sacubitril/Valsartan | The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs. | Safety Set (SAF): all participants who received at least one dose of open-label study treatment. | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months. |
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Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sacubitril/Valsartan | The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. | 0 | 8 | 1 | 8 | 6 | 8 |
| EG001 | All Patients | All Patients | 0 | 8 | 1 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (27.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2024 | Jan 27, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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