Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-28 @ 6:01 AM
Study NCT ID:
NCT02678312
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2016-02-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'Romania', 'South Africa', 'Sweden']}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}, {'id': 'D004656', 'term': 'Enalapril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "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 or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.', 'description': 'Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.\n\nOf the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Dose Cohort 1', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \\< 1 year}) or 0.8 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part 1: Dose Cohort 2', 'description': 'Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \\< 1 year}) or 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 1: Dose Cohort S', 'description': 'Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 161, 'seriousNumAtRisk': 187, 'deathsNumAffected': 8, 'seriousNumAffected': 69}, {'id': 'EG004', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 156, 'seriousNumAtRisk': 188, 'deathsNumAffected': 12, 'seriousNumAffected': 62}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Medical device pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 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'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Maximum Drug Concentration in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Sacubitril', 'categories': [{'measurements': [{'value': '523', 'spread': '390', 'groupId': 'OG000'}, {'value': '179', 'spread': '97', 'groupId': 'OG001'}, {'value': '1970', 'spread': '1666', 'groupId': 'OG002'}, {'value': '549', 'spread': '298', 'groupId': 'OG003'}, {'value': '124', 'spread': '80', 'groupId': 'OG004'}, {'value': '433', 'spread': '181', 'groupId': 'OG005'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '1951', 'spread': '839', 'groupId': 'OG000'}, {'value': '1359', 'spread': '711', 'groupId': 'OG001'}, {'value': '6707', 'spread': '1887', 'groupId': 'OG002'}, {'value': '5453', 'spread': '1032', 'groupId': 'OG003'}, {'value': '632', 'spread': '89', 'groupId': 'OG004'}, {'value': '2326', 'spread': '629', 'groupId': 'OG005'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '1271', 'spread': '1011', 'groupId': 'OG000'}, {'value': '1112', 'spread': '583', 'groupId': 'OG001'}, {'value': '4035', 'spread': '1678', 'groupId': 'OG002'}, {'value': '4935', 'spread': '1268', 'groupId': 'OG003'}, {'value': '440', 'spread': '275', 'groupId': 'OG004'}, {'value': '2487', 'spread': '1564', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).', 'unitOfMeasure': 'nanograms per milliliter (ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 Pharmacokinetic (PK) Set: included all participants who completed Part 1 screening phase; who had received at least one dose of study drug during Part 1, and had at least one available, valid, PK concentration measurement (not flagged for exclusion or considered a protocol deviation from relevant PK data) during Part 1.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Time to Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Sacubitril', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG005'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '3.2', 'groupId': 'OG003'}, {'value': '2.8', 'spread': '1.6', 'groupId': 'OG004'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG005'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '1.5', 'groupId': 'OG004'}, {'value': '1.8', 'spread': '1.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of Tmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Part 1 PK Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Sacubitril', 'categories': [{'measurements': [{'value': '690', 'spread': '410', 'groupId': 'OG000'}, {'value': '494', 'spread': '286', 'groupId': 'OG001'}, {'value': '3021', 'spread': '1814', 'groupId': 'OG002'}, {'value': '1214', 'spread': '684', 'groupId': 'OG003'}, {'value': '270', 'spread': '182', 'groupId': 'OG004'}, {'value': '1063', 'spread': '266', 'groupId': 'OG005'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '48264', 'spread': '22939', 'groupId': 'OG000'}, {'value': '31042', 'spread': '17259', 'groupId': 'OG001'}, {'value': '150440', 'spread': '49515', 'groupId': 'OG002'}, {'value': '127625', 'spread': '35634', 'groupId': 'OG003'}, {'value': '15835', 'spread': '2912', 'groupId': 'OG004'}, {'value': '62377', 'spread': '16035', 'groupId': 'OG005'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '13540', 'spread': '12962', 'groupId': 'OG000'}, {'value': '11036', 'spread': '7031', 'groupId': 'OG001'}, {'value': '40733', 'spread': '21003', 'groupId': 'OG002'}, {'value': '48561', 'spread': '21163', 'groupId': 'OG003'}, {'value': '3923', 'spread': '1424', 'groupId': 'OG004'}, {'value': '26170', 'spread': '16826', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of AUCinf was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Part 1 PK Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Number of Participants With Area Under the Plasma Concentration-time Curve From Time Zero to Last (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'As prespecified in protocol and SAP the analysis of this outcome measure was done based on dose of LCZ696 administered within the different age groups.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Part 1 PK Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, and Valsartan): Clearance From Plasma (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Sacubitril', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '1.67', 'spread': '1.01', 'groupId': 'OG003'}, {'value': '1.19', 'spread': '1.11', 'groupId': 'OG004'}, {'value': '1.67', 'spread': '1.01', 'groupId': 'OG005'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.01', 'groupId': 'OG003'}, {'value': '0.06', 'spread': '0.02', 'groupId': 'OG004'}, {'value': '0.05', 'spread': '0.03', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses was based on plasma concentrations of two sacubitril/valsartan analytes (AHU377 (sacubitril), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s). CL/F was not estimated for LBQ657 as it is a metabolite.', 'unitOfMeasure': 'liter per hour per kilograms (L/hr/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Part 1 PK Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril): Time Required to Drug Concentration to Decrease by Half (T 1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '2.36'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '1.40', 'upperLimit': '1.65'}, {'value': '1.34', 'groupId': 'OG002', 'lowerLimit': '1.16', 'upperLimit': '1.60'}, {'value': '1.51', 'groupId': 'OG003', 'lowerLimit': '1.34', 'upperLimit': '1.70'}, {'value': '1.33', 'groupId': 'OG005', 'lowerLimit': '1.16', 'upperLimit': '1.64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of T1/2 was based on plasma concentrations of sacubitril. The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s). T1/2 for other analytes of LCZ696 (LBQ657 and Valsartan) was not estimable due to the short sample collection timeframe.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 PK Set. The overall number of participants analyzed is the number of participants with data available for this endpoint. T1/2 could not be determined for participants under the arm LCZ696: 0.4 mg/kg (Age Group 3) as their PK data was inadequate for the T1/2 calculation. As participants were from the age of 1 month to less than 1 year, it was difficult to obtain multiple PK samples.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacodynamics (PD) of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma B-type Natriuretic Peptide (BNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Baseline (0 hrs pre dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.87', 'groupId': 'OG000', 'lowerLimit': '49.84', 'upperLimit': '204.13'}, {'value': '63.80', 'groupId': 'OG001', 'lowerLimit': '8.65', 'upperLimit': '470.81'}, {'value': '97.52', 'groupId': 'OG002', 'lowerLimit': '51.59', 'upperLimit': '184.32'}, {'value': '120.51', 'groupId': 'OG003', 'lowerLimit': '5.21', 'upperLimit': '2787.44'}, {'value': '21.20', 'groupId': 'OG004', 'lowerLimit': '2.14', 'upperLimit': '210.41'}, {'value': '129.29', 'groupId': 'OG005', 'lowerLimit': '9.45', 'upperLimit': '1768.43'}]}]}, {'title': 'Change From Baseline (4 hrs post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '1.85'}, {'value': '1.60', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '11.95'}, {'value': '1.22', 'groupId': 'OG002', 'lowerLimit': '0.94', 'upperLimit': '1.58'}, {'value': '0.62', 'comment': 'The 95% confidence interval (CI) was not estimable for one participant', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.77', 'groupId': 'OG004', 'lowerLimit': '0.56', 'upperLimit': '1.05'}, {'value': '1.09', 'groupId': 'OG005', 'lowerLimit': '0.61', 'upperLimit': '1.93'}]}]}, {'title': 'Change From Baseline (8 hrs post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.88'}, {'value': '1.21', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '7.04'}, {'value': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.70', 'upperLimit': '1.34'}, {'value': '0.80', 'comment': 'The 95% CI was not estimable for one participant', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.59', 'groupId': 'OG004', 'lowerLimit': '0.27', 'upperLimit': '1.30'}, {'value': '0.55', 'groupId': 'OG005', 'lowerLimit': '0.15', 'upperLimit': '2.02'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (0 hrs pre dose), 4 and 8 hrs post dose on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma BNP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.', 'unitOfMeasure': 'picomoles per liter (pmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 PD set (PD1) included all participants who completed the Part 1 screening phase and had at least one dose of study drug during Part 1 of the study, at least one available PD measurement during Part 1 of the study and with no protocol deviations with relevant impact on PD data. Overall number of participants analyzed is the number of participants with data available for this endpoint.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma N-terminal Pro-brain Natriuretic Peptide (NTproBNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Baseline (0 hrs pre dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2385.34', 'groupId': 'OG000', 'lowerLimit': '1186.13', 'upperLimit': '4796.98'}, {'value': '2179.94', 'groupId': 'OG002', 'lowerLimit': '932.77', 'upperLimit': '5094.69'}, {'value': '961.76', 'groupId': 'OG004', 'lowerLimit': '125.65', 'upperLimit': '7361.70'}, {'value': '5086.37', 'groupId': 'OG005', 'lowerLimit': '683.53', 'upperLimit': '37849.47'}]}]}, {'title': 'Change From Baseline (24 hrs post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '1.78'}, {'value': '0.59', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '134.25'}, {'value': '0.41', 'groupId': 'OG005', 'lowerLimit': '0.34', 'upperLimit': '0.48'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (0 hrs pre dose) and optional 24 hrs post dosing on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma NTproBNP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.', 'unitOfMeasure': 'picograms per millilitre (pg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 PD set. The overall number of participants analyzed is the number of participants with data available for this endpoint. Data has not been reported for the arms of LCZ696: 0.8 mg/kg (Age Group 2) and LCZ696: 3.1 mg/kg (Age Group 2) as no participants participated in the optional 24 hrs post-dose assessment.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma Cyclic Guanosine Monophosphate (cGMP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Baseline (0 hrs pre dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.18', 'groupId': 'OG000', 'lowerLimit': '12.01', 'upperLimit': '27.51'}, {'value': '21.41', 'groupId': 'OG001', 'lowerLimit': '12.83', 'upperLimit': '35.71'}, {'value': '12.20', 'groupId': 'OG002', 'lowerLimit': '8.13', 'upperLimit': '18.32'}, {'value': '24.55', 'groupId': 'OG003', 'lowerLimit': '18.37', 'upperLimit': '32.82'}, {'value': '13.38', 'groupId': 'OG004', 'lowerLimit': '0.05', 'upperLimit': '3883.59'}, {'value': '22.84', 'groupId': 'OG005', 'lowerLimit': '12.51', 'upperLimit': '41.68'}]}]}, {'title': 'Change From Baseline (4 hrs post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.90'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.62'}, {'value': '1.54', 'groupId': 'OG002', 'lowerLimit': '1.12', 'upperLimit': '2.10'}, {'value': '1.02', 'groupId': 'OG003', 'lowerLimit': '0.52', 'upperLimit': '2.01'}, {'value': '0.80', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '618.02'}, {'value': '0.78', 'groupId': 'OG005', 'lowerLimit': '0.27', 'upperLimit': '2.22'}]}]}, {'title': 'Change From Baseline (8 hrs post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.50'}, {'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '1.29'}, {'value': '1.60', 'groupId': 'OG002', 'lowerLimit': '1.10', 'upperLimit': '2.31'}, {'value': '0.40', 'groupId': 'OG003', 'lowerLimit': '0.02', 'upperLimit': '8.86'}, {'value': '0.79', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '230.10'}, {'value': '0.79', 'groupId': 'OG005', 'lowerLimit': '0.29', 'upperLimit': '2.18'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (0 hrs pre dose), 4 and 8 hrs post dose on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma cGMP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.', 'unitOfMeasure': 'nanomoles per litre (nmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 PD set. The overall number of participants analyzed is the number of participants with data available for this endpoint.'}, {'type': 'PRIMARY', 'title': 'Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Urine cGMP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.'}], 'classes': [{'title': 'Baseline (0 hrs pre dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1055.56', 'groupId': 'OG000', 'lowerLimit': '352.98', 'upperLimit': '3156.55'}, {'value': '1349.91', 'groupId': 'OG001', 'lowerLimit': '118.48', 'upperLimit': '15380.33'}, {'value': '914.57', 'groupId': 'OG002', 'lowerLimit': '311.65', 'upperLimit': '2683.88'}, {'value': '1123.69', 'groupId': 'OG003', 'lowerLimit': '75.21', 'upperLimit': '16789.03'}, {'value': '485.00', 'comment': 'The 95% CI was not estimable for one participant', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '386.32', 'groupId': 'OG005', 'lowerLimit': '134.04', 'upperLimit': '1113.42'}]}]}, {'title': 'Change From Baseline (4 to 8 hrs post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.42', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '5.32'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '27.03'}, {'value': '1.79', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '4.96'}, {'value': '2.17', 'groupId': 'OG003', 'lowerLimit': '0.10', 'upperLimit': '45.16'}, {'value': '0.92', 'groupId': 'OG004', 'lowerLimit': '0.02', 'upperLimit': '51.75'}, {'value': '1.98', 'groupId': 'OG005', 'lowerLimit': '0.51', 'upperLimit': '7.63'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (0 hrs pre dose), 4 to 8 hrs post dose on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included urine cGMP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 PD set. The overall number of participants analyzed is the number of participants with data available for this endpoint.'}, {'type': 'PRIMARY', 'title': 'Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}], 'classes': [{'title': 'Category 1', 'categories': [{'measurements': [{'value': '10.16', 'groupId': 'OG000'}, {'value': '15.96', 'groupId': 'OG001'}]}]}, {'title': 'Category 2', 'categories': [{'measurements': [{'value': '9.63', 'groupId': 'OG000'}, {'value': '4.79', 'groupId': 'OG001'}]}]}, {'title': 'Category 3', 'categories': [{'measurements': [{'value': '6.95', 'groupId': 'OG000'}, {'value': '5.85', 'groupId': 'OG001'}]}]}, {'title': 'Category 4', 'categories': [{'measurements': [{'value': '20.86', 'groupId': 'OG000'}, {'value': '26.60', 'groupId': 'OG001'}]}]}, {'title': 'Category 5', 'categories': [{'measurements': [{'value': '39.57', 'groupId': 'OG000'}, {'value': '35.64', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '12.83', 'groupId': 'OG000'}, {'value': '11.17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'Global ranking is based on 5 categories ranking worst to best outcome:Category 1:Death; United Network for Organ Sharing(UNOS)status 1A listing for heart transplant or equivalent; ventricular assist device(VAD)/extracorporeal membrane oxygenation(ECMO)/mechanical ventilation/intra-aortic balloon pump requirement for life support at end of study. Category 2:Worsening HF(WHF);defined by signs and symptoms of WHF that requires an intensification of HF therapy. Category 3:Worsened; worse New York Heart Association(NYHA)/Ross or worse Patient Global Impression of Severity(PGIS); and further ranking by Pediatric Quality of Life Inventory(PedsQL)physical functioning domain.Category 4:Unchanged; unchanged NYHA/Ross and unchanged PGIS; and further ranking by PedsQL physical functioning domain. Category 5:Improved; improved NYHA/Ross or improved PGIS(neither can be worse);and further ranking by PedsQL physical functioning domain. Participants with worst event in each category are reported here.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants with the exception of those participants who had not been qualified for randomization and had not received study drug but had been inadvertently randomized into the study. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696: 0.8 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \\< 1 year}) or 0.8 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.'}, {'id': 'OG001', 'title': 'LCZ696: 0.8 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1.\n\nParticipants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG002', 'title': 'LCZ696: 3.1 mg/kg (Age Group 1)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.'}, {'id': 'OG003', 'title': 'LCZ696: 3.1 mg/kg (Age Group 2)', 'description': 'Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.'}, {'id': 'OG004', 'title': 'LCZ696: 0.4 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period\n\n1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.'}, {'id': 'OG005', 'title': 'LCZ696: 1.6 mg/kg (Age Group 3)', 'description': 'Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1.\n\nParticipants ranging from age 1 month to 1 year were included in this group.'}, {'id': 'OG006', 'title': 'Part 1: Dose Cohort S', 'description': 'Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.57', 'groupId': 'OG000'}, {'value': '50.00', 'groupId': 'OG001'}, {'value': '28.57', 'groupId': 'OG002'}, {'value': '50.00', 'groupId': 'OG003'}, {'value': '50.00', 'groupId': 'OG004'}, {'value': '80.00', 'groupId': 'OG005'}, {'value': '50.00', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to 30 days after last dose of study drug in Part 1', 'description': 'An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether considered drug related or not, that occurs after a participant provides informed consent. TEAEs during part 1 are defined as any recorded AE with its start date (recorded or imputed) later than or equal to the date of the first dose of the study drug within part 1 and its start date prior to or equal to the end date of the part 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 Safety Analysis Set (SAF1) included all participants who completed the Part 1 screening phase and received at least one dose of study drug during Part 1 of the study.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.77', 'groupId': 'OG000'}, {'value': '87.77', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to 30 days after last dose of study drug in Part 2 (up to 56 weeks)', 'description': 'An AE is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAEs during part 2 are defined as any recorded AE with its start date (recorded or imputed) later than or equal to the date of the first dose of the study drug within part 2 and its start date prior to or equal to the end date of part 2.', 'unitOfMeasure': 'percentage of participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2: Safety Set included randomized participants who received at least one dose of study drug. Participants were analyzed according to the treatment actually received. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Exposure-adjusted Incidence Rate of Category 1 or Category 2 Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.133', 'groupId': 'OG000', 'lowerLimit': '13.9430', 'upperLimit': '28.1344'}, {'value': '20.042', 'groupId': 'OG001', 'lowerLimit': '13.7960', 'upperLimit': '28.1464'}]}]}], 'analyses': [{'pValue': '0.7958', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0655', 'ciLowerLimit': '0.6589', 'ciUpperLimit': '1.7232', 'pValueComment': 'The adjusted hazard ratio and the p-values are based on a Cox proportional hazard model, stratified by modified age group with treatment and NYHA/ROSS class group included as factor.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'The exposure adjusted incidence rate is calculated as number of participants with at least one event divided by total participant years across all participants. Category 1: Death; UNOS status 1A listing for heart transplant or equivalent; VAD/ECMO/mechanical ventilation/intra-aortic balloon pump requirement for life support at end of study. Category 2: WHF; defined by signs and symptoms of WHF that requires an intensification of HF therapy.', 'unitOfMeasure': 'participant per participant years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants with the exception of those participants who had not been qualified for randomization and had not received study drug but had been inadvertently randomized into the study. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}], 'classes': [{'title': 'Change from Baseline at Week 4: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.21', 'groupId': 'OG000'}, {'value': '15.67', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.15', 'groupId': 'OG000'}, {'value': '82.61', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000'}, {'value': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.89', 'groupId': 'OG000'}, {'value': '25.56', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.56', 'groupId': 'OG000'}, {'value': '67.78', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.56', 'groupId': 'OG000'}, {'value': '6.67', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.97', 'groupId': 'OG000'}, {'value': '27.91', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.04', 'groupId': 'OG000'}, {'value': '63.95', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.99', 'groupId': 'OG000'}, {'value': '8.14', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.94', 'groupId': 'OG000'}, {'value': '34.12', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.08', 'groupId': 'OG000'}, {'value': '58.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.98', 'groupId': 'OG000'}, {'value': '7.65', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.66', 'groupId': 'OG000'}, {'value': '33.96', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.65', 'groupId': 'OG000'}, {'value': '56.60', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.69', 'groupId': 'OG000'}, {'value': '9.43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4, 12, 24, 36, and 52', 'description': "NYHA classification is a subjective physician's assessment of participant's functional capacity and symptomatic status and can change frequently over time. NYHA is tool that classifies participants with heart failure into one of four classes according to their degree of symptoms at rest and with activity. Class I: No limitations of physical activity. Class 2: May experience fatigue, palpitations, dyspnea, or angina during moderate exercise but not during rest. Class 3: Symptoms with minimal exertion that interfere with normal daily activity. Class 4: Unable to carry out any physical activity because they typically have symptoms of HF at rest that worsen with any exertion. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data were analyzed. The number analyzed is the number of participants with data available for analyses at specific timepoints. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}], 'classes': [{'title': 'Change from Baseline at Week 4: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.01', 'groupId': 'OG000'}, {'value': '29.67', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.05', 'groupId': 'OG000'}, {'value': '59.89', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.94', 'groupId': 'OG000'}, {'value': '10.44', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.90', 'groupId': 'OG000'}, {'value': '31.46', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.25', 'groupId': 'OG000'}, {'value': '55.62', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.85', 'groupId': 'OG000'}, {'value': '12.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}, {'value': '38.01', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.85', 'groupId': 'OG000'}, {'value': '48.54', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.82', 'groupId': 'OG000'}, {'value': '13.45', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}, {'value': '33.94', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.38', 'groupId': 'OG000'}, {'value': '52.73', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 36: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.28', 'groupId': 'OG000'}, {'value': '13.33', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.53', 'groupId': 'OG000'}, {'value': '34.81', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52: Unchanged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.03', 'groupId': 'OG000'}, {'value': '47.47', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 52: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.45', 'groupId': 'OG000'}, {'value': '17.72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4, 12, 24, 36, and 52', 'description': "PGIS of Heart Failure Symptoms is a 1-item questionnaire to assess the participant's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the participant to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-point scale, ranging from 'Not at all' (1) to 'Very severe' (5). C1 = none (good), C2 = mild, C3 = moderate, C4 = severe, C5 = very severe (bad). Percentage of participants by change in score are reported. Participants with change from baseline were classified as improved (shifted from higher to score), unchanged (no change in score) or worsened (shifted from lower to higher score).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data were analyzed. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analyses at specific timepoints. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Clearance From Plasma (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.93', 'spread': '19.29', 'groupId': 'OG000'}]}]}, {'title': 'LBQ657', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Valsartan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.97', 'spread': '1.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of CL was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Volume of Distribution in Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '5.84', 'groupId': 'OG000'}]}]}, {'title': 'LBQ657', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Valsartan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of volume of distribution was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': 'L/Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Absorption Rate Constant (Ka)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'LBQ657', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Valsartan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of Ka was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': '1/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Time Required to Drug Concentration to Decrease by Half (T 1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.51', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '199.55'}]}]}, {'title': 'LBQ657', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.21', 'groupId': 'OG000', 'lowerLimit': '6.08', 'upperLimit': '107.47'}]}]}, {'title': 'Valsartan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.96', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '81.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of T1/2 was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Maximum Drug Concentration in Plasma at Steady State (Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1348', 'spread': '627', 'groupId': 'OG000'}]}]}, {'title': 'LBQ657', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10153', 'spread': '3591', 'groupId': 'OG000'}]}]}, {'title': 'Valsartan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3861', 'spread': '1770', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63', 'spread': '141', 'groupId': 'OG000'}]}]}, {'title': 'LBQ657', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6442', 'spread': '3474', 'groupId': 'OG000'}]}]}, {'title': 'Valsartan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1442', 'spread': '1564', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of Cmin was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady State (AUCtau,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 (Part 1 and 2)', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3) or 0.8 mg/kg (age group 1 and 2) on Day 1 of Period 1 and 1.6 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2) on Day 1 of Period 2, based on age, given as a single oral dose in Part 1. Followed by Part 1, participants were enrolled in Part 2 and received LCZ696 2.3 mg/kg (age group 3) or 3.1 mg/kg (age group 1 and 2), based on age, orally, twice a day (BID) for 52 weeks in Part 2.'}], 'classes': [{'title': 'Sacubitril', 'categories': [{'measurements': [{'value': '2179', 'spread': '2241', 'groupId': 'OG000'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '98906', 'spread': '41944', 'groupId': 'OG000'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '28672', 'spread': '19686', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of AUCtau was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.', 'unitOfMeasure': 'ng/mL*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Dose Cohort 1', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \\< 1 year}) or 0.8 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.'}, {'id': 'FG001', 'title': 'Part 1: Dose Cohort 2', 'description': 'Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \\< 1 year}) or 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.'}, {'id': 'FG002', 'title': 'Part 1: Dose Cohort S', 'description': 'Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.'}, {'id': 'FG003', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'FG004', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}], 'periods': [{'title': 'Part 1 Open Label Epoch- Period 1', 'milestones': [{'type': 'STARTED', 'comment': 'Out of 26 participants enrolled in the Part 1 of the study, 17 were dosed based on their age to receive LCZ696 0.8 mg or 0.4 mg in Period 1.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part 1 Open Label Epoch- Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Out of 26 participants enrolled in Part 1, 18 participants were dosed in dose cohort 2 to receive LCZ696 1.6 mg or 3.1 mg dose in Period 2. A total of 9 participants who received LCZ696 in Dose cohort 1, received drug further in dose cohort 2 and 9 others received drug directly in Period 2 were included in Dose cohort 2.', 'groupId': 'FG001', 'numSubjects': '18'}, {'comment': '2 participants who were dosed in Dose Cohort 2 at dose level 3.1 mg/kg were then prescribed one dose of study drug at dose level 0.8 mg/kg within period 2 and were therefore grouped under Dose cohort S.', 'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part 2 Double Blind Epoch', 'milestones': [{'type': 'STARTED', 'comment': 'Out of 377 participants enrolled in Part 2 of the study, 2 participants in the enalapril arm were randomized in error and did not receive the study medication. Therefore, 375 of 377 randomized participants received study medication.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '187'}, {'groupId': 'FG004', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '169'}, {'groupId': 'FG004', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Subject/guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '2-Part (Pt) Study: Pt 1 a single dose PK/PD study with 2 dose levels; Pt 2 is a 52-week, double blind, active controlled, randomized, safety \\& efficacy study. In Pt 1, there were 3 age groups: 6 to \\<18 yrs, 1 to \\<6 yrs and 1 month to \\<1 yr. Each received either a single low dose LCZ696 (Cohort 1), a single high dose LCZ696 (Cohort 2) or both. Cohort S included patients receiving a single low dose after having received a single high dose. The low/high doses for groups 1/2 were 0.8 \\& 3.1 (mg/kg).', 'preAssignmentDetails': 'The low and high doses for Group 3 0.4 mg/kg and 1.6 mg/kg, respectively. 26 patients received either one or two single doses of LCZ696 in Pt 1. In Pt 2, patients were randomized to receive either LCZ696 or enalapril. 377 patients were randomized and 375 received study drug (2 did not receive drug). 11 of 26 Pt 1 patients rolled into Pt 2; however, 1 patient had two ID numbers; so only 10 unique patients were in Pt 1 \\& 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}, {'value': '412', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Dose Cohort 1', 'description': 'Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \\< 1 year}) or 0.8 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.'}, {'id': 'BG001', 'title': 'Part 1: Dose Cohort 2', 'description': 'Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \\< 1 year}) or 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.'}, {'id': 'BG002', 'title': 'Part 1: Dose Cohort S', 'description': 'Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.'}, {'id': 'BG003', 'title': 'Part 2: LCZ696', 'description': 'Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.'}, {'id': 'BG004', 'title': 'Part 2: Enalapril', 'description': 'Participants received enalapril 0.2 mg/kg (age group 1 {6 to \\<18 years} and age group 2 {1 to \\< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \\< 1 year}), based on age, orally, BID, for 52 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'BG000', 'lowerLimit': '0.30', 'upperLimit': '16.00'}, {'value': '2.50', 'groupId': 'BG001', 'lowerLimit': '0.20', 'upperLimit': '17.00'}, {'value': '1.55', 'groupId': 'BG002', 'lowerLimit': '1.10', 'upperLimit': '2.00'}, {'value': '7.00', 'groupId': 'BG003', 'lowerLimit': '0.50', 'upperLimit': '17.00'}, {'value': '8.50', 'groupId': 'BG004', 'lowerLimit': '0.10', 'upperLimit': '18.00'}, {'value': '4.51', 'groupId': 'BG005', 'lowerLimit': '0.10', 'upperLimit': '18.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '207', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '205', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}, {'value': '279', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '196', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set included all randomized participants who received study drug, with the exception of \\[2 patients in Part 2\\] who had not received any study drug, but had been inadvertently randomized into the study (mis-randomized).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-15', 'size': 2906350, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-29T12:18', 'hasProtocol': True}, {'date': '2021-10-29', 'size': 598012, 'label': 'Statistical Analysis Plan: Original Statistical Analysis Plan (SAP)', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-29T12:18', 'hasProtocol': False}, {'date': '2021-10-25', 'size': 341246, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan (SAP) for China Sub-CSR', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-29T12:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 393}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2016-02-04', 'resultsFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-12', 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Maximum Drug Concentration in Plasma (Cmax)', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).'}, {'measure': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of Tmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).'}, {'measure': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of AUCinf was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).'}, {'measure': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Number of Participants With Area Under the Plasma Concentration-time Curve From Time Zero to Last (AUClast)', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'As prespecified in protocol and SAP the analysis of this outcome measure was done based on dose of LCZ696 administered within the different age groups.'}, {'measure': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, and Valsartan): Clearance From Plasma (CL/F)', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses was based on plasma concentrations of two sacubitril/valsartan analytes (AHU377 (sacubitril), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s). CL/F was not estimated for LBQ657 as it is a metabolite.'}, {'measure': 'Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril): Time Required to Drug Concentration to Decrease by Half (T 1/2)', 'timeFrame': 'Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2', 'description': 'The analyses of T1/2 was based on plasma concentrations of sacubitril. The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s). T1/2 for other analytes of LCZ696 (LBQ657 and Valsartan) was not estimable due to the short sample collection timeframe.'}, {'measure': 'Part 1: Pharmacodynamics (PD) of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma B-type Natriuretic Peptide (BNP)', 'timeFrame': 'Baseline (0 hrs pre dose), 4 and 8 hrs post dose on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma BNP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.'}, {'measure': 'Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma N-terminal Pro-brain Natriuretic Peptide (NTproBNP)', 'timeFrame': 'Baseline (0 hrs pre dose) and optional 24 hrs post dosing on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma NTproBNP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.'}, {'measure': 'Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma Cyclic Guanosine Monophosphate (cGMP)', 'timeFrame': 'Baseline (0 hrs pre dose), 4 and 8 hrs post dose on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma cGMP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.'}, {'measure': 'Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Urine cGMP', 'timeFrame': 'Baseline (0 hrs pre dose), 4 to 8 hrs post dose on Day 1 of Period 1 and Period 2', 'description': 'Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included urine cGMP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.'}, {'measure': 'Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking', 'timeFrame': 'Up to 52 weeks', 'description': 'Global ranking is based on 5 categories ranking worst to best outcome:Category 1:Death; United Network for Organ Sharing(UNOS)status 1A listing for heart transplant or equivalent; ventricular assist device(VAD)/extracorporeal membrane oxygenation(ECMO)/mechanical ventilation/intra-aortic balloon pump requirement for life support at end of study. Category 2:Worsening HF(WHF);defined by signs and symptoms of WHF that requires an intensification of HF therapy. Category 3:Worsened; worse New York Heart Association(NYHA)/Ross or worse Patient Global Impression of Severity(PGIS); and further ranking by Pediatric Quality of Life Inventory(PedsQL)physical functioning domain.Category 4:Unchanged; unchanged NYHA/Ross and unchanged PGIS; and further ranking by PedsQL physical functioning domain. Category 5:Improved; improved NYHA/Ross or improved PGIS(neither can be worse);and further ranking by PedsQL physical functioning domain. Participants with worst event in each category are reported here.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose to 30 days after last dose of study drug in Part 1', 'description': 'An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether considered drug related or not, that occurs after a participant provides informed consent. TEAEs during part 1 are defined as any recorded AE with its start date (recorded or imputed) later than or equal to the date of the first dose of the study drug within part 1 and its start date prior to or equal to the end date of the part 1.'}, {'measure': 'Part 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose to 30 days after last dose of study drug in Part 2 (up to 56 weeks)', 'description': 'An AE is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAEs during part 2 are defined as any recorded AE with its start date (recorded or imputed) later than or equal to the date of the first dose of the study drug within part 2 and its start date prior to or equal to the end date of part 2.'}, {'measure': 'Part 2: Exposure-adjusted Incidence Rate of Category 1 or Category 2 Event', 'timeFrame': '52 weeks', 'description': 'The exposure adjusted incidence rate is calculated as number of participants with at least one event divided by total participant years across all participants. Category 1: Death; UNOS status 1A listing for heart transplant or equivalent; VAD/ECMO/mechanical ventilation/intra-aortic balloon pump requirement for life support at end of study. Category 2: WHF; defined by signs and symptoms of WHF that requires an intensification of HF therapy.'}, {'measure': 'Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class', 'timeFrame': 'Baseline, Week 4, 12, 24, 36, and 52', 'description': "NYHA classification is a subjective physician's assessment of participant's functional capacity and symptomatic status and can change frequently over time. NYHA is tool that classifies participants with heart failure into one of four classes according to their degree of symptoms at rest and with activity. Class I: No limitations of physical activity. Class 2: May experience fatigue, palpitations, dyspnea, or angina during moderate exercise but not during rest. Class 3: Symptoms with minimal exertion that interfere with normal daily activity. Class 4: Unable to carry out any physical activity because they typically have symptoms of HF at rest that worsen with any exertion. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class)."}, {'measure': 'Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score', 'timeFrame': 'Baseline, Week 4, 12, 24, 36, and 52', 'description': "PGIS of Heart Failure Symptoms is a 1-item questionnaire to assess the participant's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the participant to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-point scale, ranging from 'Not at all' (1) to 'Very severe' (5). C1 = none (good), C2 = mild, C3 = moderate, C4 = severe, C5 = very severe (bad). Percentage of participants by change in score are reported. Participants with change from baseline were classified as improved (shifted from higher to score), unchanged (no change in score) or worsened (shifted from lower to higher score)."}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Clearance From Plasma (CL)', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of CL was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Volume of Distribution in Steady State', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of volume of distribution was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Absorption Rate Constant (Ka)', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of Ka was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Time Required to Drug Concentration to Decrease by Half (T 1/2)', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of T1/2 was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Maximum Drug Concentration in Plasma at Steady State (Cmax,ss)', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss)', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of Cmin was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}, {'measure': 'Part 1 and Part 2: Population PK of LCZ696 Analytes: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady State (AUCtau,ss)', 'timeFrame': 'Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52', 'description': 'The analyses of AUCtau was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Pediatric Heart failure,', 'systemic left ventricle,', 'reduced ejection fraction'], 'conditions': ['Pediatric Heart Failure']}, 'referencesModule': {'references': [{'pmid': '39319469', 'type': 'DERIVED', 'citation': 'Shaddy R, Burch M, Kantor PF, Solar-Yohay S, Garito T, Zhang S, Kocun M, Mao C, Cilliers A, Wang X, Canter C, Rossano J, Wallis G, Menteer J, Daou L, Kusa J, Tokel K, Dilber D, Xu Z, Xiao T, Halnon N, Daly KP, Bock MJ, Zuckerman W, Singh TP, Chakrabarti M, Levitas A, Senni M, Grutter G, Kim GB, Song J, Lee HD, Chen CK, Sanchez-de-Toledo J, Law Y, Wanitkun S, Cui Y, Anjos R, Mese T, Bonnet D; PANORAMA-HF Investigators. Sacubitril/Valsartan in Pediatric Heart Failure (PANORAMA-HF): A Randomized, Multicenter, Double-Blind Trial. Circulation. 2024 Nov 26;150(22):1756-1766. doi: 10.1161/CIRCULATIONAHA.123.066605. Epub 2024 Sep 25.'}, {'pmid': '36601956', 'type': 'DERIVED', 'citation': 'Shaddy R, Burch M, Kantor PF, Solar-Yohay S, Garito T, Zhang S, Kocun M, Bonnet D. Baseline Characteristics of Pediatric Patients With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction in the PANORAMA-HF Trial. Circ Heart Fail. 2023 Mar;16(3):e009816. doi: 10.1161/CIRCHEARTFAILURE.122.009816. Epub 2023 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.\n\nThe purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.', 'detailedDescription': 'This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.\n\nThe purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Chronic heart failure (CHF) resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)\n* New York Heart Association (NYHA) classification II-IV (older children: 6 to \\<18 years old) or Ross CHF classification II-IV (younger children: \\< 6 years old)\n* Systemic left ventricular ejection fraction ≤ 45% or fractional shortening ≤22.5%\n* For Part 1 study: Patients must be treated with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB) prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg.\n* Biventricular physiology with systemic left ventricle\n\nKey Exclusion Criteria:\n\n* Patient with single ventricle or systemic right ventricle\n* Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device)\n* Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy\n* Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2\n* Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction\n* Patients with restrictive or hypertrophic cardiomyopathy\n* Active myocarditis\n* Renal vascular hypertension (including renal artery stenosis)\n* Moderate-to severe obstructive pulmonary disease\n* Serum potassium \\> 5.3 mmol/L\n* History of angioedema\n* Allergy or hypersensitivity to ACEI / ARB'}, 'identificationModule': {'nctId': 'NCT02678312', 'briefTitle': 'Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction', 'orgStudyIdInfo': {'id': 'CLCZ696B2319'}, 'secondaryIdInfos': [{'id': '2015-004207-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: LCZ696 open label', 'description': 'LCZ696 open label: For Age Groups 1 and 2, either 1) 0.8 mg/kg or 2) 3.1 mg/kg or both. For Age Group 3, either 1) 0.4 mg/kg or 2) 1.6 mg/kg or both. After LCZ696 PK assessment, patients will be maintained on open-label Enalapril provided locally by the study site, or standard of care also provided locally by the study site, for heart failure treatment, if patient intended to participate in Part 2.', 'interventionNames': ['Drug: LCZ696', 'Drug: Enalapril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Enalapril', 'description': 'The target dose for enalapril is 0.2 mg/kg bid (0.4 mg/kg total daily dose) with a maximum dose of 10 mg bid (20 mg total daily dose). Administered in a double-blind fashion.', 'interventionNames': ['Drug: Enalapril', 'Drug: Placebo of LCZ696']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LCZ696', 'description': 'LCZ696 3.125 mg granules and adult formulation (50, 100, 200 mg) can be given based on patient weight. Administered in a double-blind fashion.', 'interventionNames': ['Drug: LCZ696', 'Drug: Placebo of Enalapril']}], 'interventions': [{'name': 'LCZ696', 'type': 'DRUG', 'description': 'LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules)', 'armGroupLabels': ['Part 1: LCZ696 open label', 'Part 2: LCZ696']}, {'name': 'Enalapril', 'type': 'DRUG', 'description': 'Enalapril tablets: 2.5 mg, 5 mg, 10 mg dosage strengths', 'armGroupLabels': ['Part 1: LCZ696 open label', 'Part 2: Enalapril']}, {'name': 'Placebo of LCZ696', 'type': 'DRUG', 'armGroupLabels': ['Part 2: Enalapril']}, {'name': 'Placebo of Enalapril', 'type': 'DRUG', 'armGroupLabels': ['Part 2: LCZ696']}, {'name': 'LCZ696', 'type': 'DRUG', 'description': 'LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), tablets: 50 mg, 100 mg, 200 mg dosage strengths', 'armGroupLabels': ['Part 2: LCZ696']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 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