Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT01621633
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2012-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': {'eventGroups': [{'id': 'EG000', 'title': 'Moderate Hepatic Impaired Patients', 'description': 'Moderate hepatic impaired patients', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BLOOD POTASSIUM DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG001', 'title': 'Participants With Moderate Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG002', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1'}, {'id': 'OG003', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2'}], 'classes': [{'title': 'AHU377', 'categories': [{'measurements': [{'value': '2540', 'spread': '1010', 'groupId': 'OG000'}, {'value': '6200', 'spread': '2970', 'groupId': 'OG001'}, {'value': '1580', 'spread': '390', 'groupId': 'OG002'}, {'value': '1740', 'spread': '520', 'groupId': 'OG003'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '118000', 'spread': '37000', 'groupId': 'OG000'}, {'value': '173000', 'spread': '99900', 'groupId': 'OG001'}, {'value': '77900', 'spread': '14700', 'groupId': 'OG002'}, {'value': '83100', 'spread': '14700', 'groupId': 'OG003'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '28500', 'spread': '16900', 'groupId': 'OG000'}, {'value': '63800', 'spread': '48700', 'groupId': 'OG001'}, {'value': '21600', 'spread': '5980', 'groupId': 'OG002'}, {'value': '25300', 'spread': '11800', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From pre-dose on Day 1 until 96h post-dose (Day 5)', 'description': 'Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set: The PK analysis set included all subjects with at least one available, valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug, and experienced no protocol deviations with relevant impact on PK data.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG001', 'title': 'Participants With Moderate Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG002', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1'}, {'id': 'OG003', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2'}], 'classes': [{'title': 'AHU377', 'categories': [{'measurements': [{'value': '2540', 'spread': '1010', 'groupId': 'OG000'}, {'value': '6200', 'spread': '2980', 'groupId': 'OG001'}, {'value': '1590', 'spread': '390', 'groupId': 'OG002'}, {'value': '1740', 'spread': '519', 'groupId': 'OG003'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '121000', 'spread': '41000', 'groupId': 'OG000'}, {'value': '187000', 'spread': '124000', 'groupId': 'OG001'}, {'value': '78500', 'spread': '14700', 'groupId': 'OG002'}, {'value': '84100', 'spread': '14800', 'groupId': 'OG003'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '28800', 'spread': '16900', 'groupId': 'OG000'}, {'value': '65600', 'spread': '50100', 'groupId': 'OG001'}, {'value': '21900', 'spread': '5950', 'groupId': 'OG002'}, {'value': '26500', 'spread': '12400', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From pre-dose on Day 1 until 96h post-dose (Day 5)', 'description': 'Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG001', 'title': 'Participants With Moderate Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG002', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1'}, {'id': 'OG003', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2'}], 'classes': [{'title': 'AHU377', 'categories': [{'measurements': [{'value': '2530', 'spread': '1400', 'groupId': 'OG000'}, {'value': '4430', 'spread': '1760', 'groupId': 'OG001'}, {'value': '1510', 'spread': '585', 'groupId': 'OG002'}, {'value': '1410', 'spread': '445', 'groupId': 'OG003'}]}]}, {'title': 'LBQ657', 'categories': [{'measurements': [{'value': '7730', 'spread': '1470', 'groupId': 'OG000'}, {'value': '6690', 'spread': '917', 'groupId': 'OG001'}, {'value': '7450', 'spread': '1320', 'groupId': 'OG002'}, {'value': '6770', 'spread': '1710', 'groupId': 'OG003'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '4000', 'spread': '2310', 'groupId': 'OG000'}, {'value': '4180', 'spread': '2340', 'groupId': 'OG001'}, {'value': '3880', 'spread': '1490', 'groupId': 'OG002'}, {'value': '3730', 'spread': '1540', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From pre-dose on Day 1 until 96h post-dose (Day 5)', 'description': 'Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG001', 'title': 'Participants With Moderate Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'OG002', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1'}, {'id': 'OG003', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2'}], 'classes': [{'title': 'Adverse events (serious and non-serious)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the screening visit until Day 5', 'description': 'Adverse events, serious adverse events and death were monitored from screening to end of study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: The safety set includes all participants who received study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'FG001', 'title': 'Participants With Moderate Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'FG002', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1'}, {'id': 'FG003', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants received the study treatment according to the population subset that was defined based on the severity of hepatic impairment and healthy volunteers: Group 1, subjects with mild hepatic impairment; Group 2, subjects with moderate hepatic impairment; Groups 3 and 4, healthy volunteers matching to Groups 1 and 2, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Mild Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'BG001', 'title': 'Participants With Moderate Hepatic Impairment (HI)', 'description': 'LCZ696 200 mg, given as a single oral dose'}, {'id': 'BG002', 'title': 'Healthy Volunteers (Mild HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1'}, {'id': 'BG003', 'title': 'Healthy Volunteers (Moderate HI Matched)', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '7.92', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '11.67', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '8.68', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '11.21', 'groupId': 'BG003'}, {'value': '59.0', 'spread': '9.54', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-11', 'studyFirstSubmitDate': '2012-06-14', 'resultsFirstSubmitDate': '2015-07-11', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-11', 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)', 'timeFrame': 'From pre-dose on Day 1 until 96h post-dose (Day 5)', 'description': 'Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)', 'timeFrame': 'From pre-dose on Day 1 until 96h post-dose (Day 5)', 'description': 'Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing'}, {'measure': 'Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)', 'timeFrame': 'From pre-dose on Day 1 until 96h post-dose (Day 5)', 'description': 'Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events, Serious Adverse Events and Death', 'timeFrame': 'From the screening visit until Day 5', 'description': 'Adverse events, serious adverse events and death were monitored from screening to end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatic impairment'], 'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects:\n\n * Male and female subjects aged 18-75 years.\n * Body weight at least 55 kg with a body mass index between 18-35 kg/m2.\n* Hepatic impairment subjects:\n\n * Mild or moderate hepatic impairment.\n\nExclusion Criteria:\n\n* All subjects:\n\n * Clinical manifestations of postural symptomatic hypotension at screening or baseline.\n * History of hypersensitivity to LCZ696 or to drugs of similar classes.\n* Hepatic impairment subjects:\n\n * Hepatic impairment due to non-liver disease.\n * Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing.\n * Encephalopathyy Stage III or IV.\n * Primary biliary liver cirrhosis or biliary obstruction.\n * History of gastro-intestinal bleeding within 3 months prior to screening.\n* Healthy subjects:\n\n * Any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n * Use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01621633', 'briefTitle': 'A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Single-dose, Open-label Parallel-group Study to Assess the Pharmacokinetics of LCZ696 in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects', 'orgStudyIdInfo': {'id': 'CLCZ696B2203'}, 'secondaryIdInfos': [{'id': '2012-000983-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: mild hepatic impairment', 'description': 'LCZ696 200 mg, given as a single oral dose', 'interventionNames': ['Drug: LCZ696']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: moderate hepatic impairment', 'description': 'LCZ696 200 mg, given as a single oral dose', 'interventionNames': ['Drug: LCZ696']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: healthy volunteers', 'description': 'LCZ696 200 mg, given as a single oral dose. Each healthy volunteer will match in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in groups 1 and 2', 'interventionNames': ['Drug: LCZ696']}], 'interventions': [{'name': 'LCZ696', 'type': 'DRUG', 'armGroupLabels': ['Group 1: mild hepatic impairment', 'Group 2: moderate hepatic impairment', 'Group 3: healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-67269', 'city': 'Grünstadt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.56302, 'lon': 8.16279}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}