Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-04-13 @ 6:55 PM
Study NCT ID:
NCT01876368
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2013-06-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Venezuela']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}, {'id': 'C437965', 'term': 'olmesartan'}]}}, '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': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.', 'otherNumAtRisk': 188, 'otherNumAffected': 7, 'seriousNumAtRisk': 188, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.', 'otherNumAtRisk': 187, 'otherNumAffected': 10, 'seriousNumAtRisk': 187, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}], 'seriousEvents': [{'term': 'BENIGN NEOPLASM OF THYROID GLAND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.26', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.19', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '-1.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 8 weeks', 'description': 'Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.27', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 8 weeks', 'description': 'Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.21', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-10.03', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 8 weeks', 'description': 'Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.52', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-4.47', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 8 weeks', 'description': 'Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Office Pulse Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.67', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-5.54', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 8 weeks', 'description': 'Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving Successful Overall Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Successful overall blood pressure control is defined as both msSBP/msDBP \\<140/90 mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Successful mean sitting systolic blood pressure control is defined as msSBP \\<140 mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Successful mean sitting diastolic blood pressure control is defined as msDBP \\<90 mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, 8 weeks', 'description': 'Successful mean sitting systolic blood pressure response is defined as msSBP \\<140 mmHg or a reduction ≥ 20 mmHg from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. 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Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Total Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'classes': [{'title': 'Adverse events (serious and non-serious)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Number of patients with total adverse events, serious adverse events and death were reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'FG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'comment': 'One patient was not included in the SAF and FAS due to mis-randomization.', 'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'Safety Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LCZ696 200 mg', 'description': 'Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'BG001', 'title': 'Olmesartan 20 mg', 'description': 'Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '10.19', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '9.09', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '9.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subject demographics and background characteristics by treatment group (Full analysis set)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2013-06-09', 'resultsFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2013-06-09', 'lastUpdatePostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-03', 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.'}, {'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean'}, {'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean'}, {'measure': 'Change From Baseline in Office Pulse Pressure', 'timeFrame': 'baseline, 8 weeks', 'description': 'Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.'}, {'measure': 'Number of Patients Achieving Successful Overall Blood Pressure Control', 'timeFrame': '8 weeks', 'description': 'Successful overall blood pressure control is defined as both msSBP/msDBP \\<140/90 mmHg'}, {'measure': 'Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control', 'timeFrame': '8 weeks', 'description': 'Successful mean sitting systolic blood pressure control is defined as msSBP \\<140 mmHg'}, {'measure': 'Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control', 'timeFrame': '8 weeks', 'description': 'Successful mean sitting diastolic blood pressure control is defined as msDBP \\<90 mmHg'}, {'measure': 'Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response', 'timeFrame': 'baseline, 8 weeks', 'description': 'Successful mean sitting systolic blood pressure response is defined as msSBP \\<140 mmHg or a reduction ≥ 20 mmHg from baseline.'}, {'measure': 'Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response', 'timeFrame': 'baseline, 8 weeks', 'description': 'Successful mean sitting diastolic blood pressure response is defined as msDBP \\<90 mmHg or a reduction ≥10 mmHg from baseline.'}, {'measure': 'Number of Patients With Total Adverse Events, Serious Adverse Events and Death', 'timeFrame': '8 weeks', 'description': 'Number of patients with total adverse events, serious adverse events and death were reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertension,', 'LCZ696,', 'olmesartan'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy\n* treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and \\< 180 mmHg after washout epoch and after 4 weeks run-in epoch\n* untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and \\< 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and \\< 180 mmHg after 4 weeks run-in epoch\n* patients must successfully complete ABPM and pass technical requirements to be qualified for randomization\n\nExclusion Criteria:\n\n* Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg 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