Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 10:56 AM
Study NCT ID:
NCT01599104
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2012-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'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': '+1 (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': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks', 'otherNumAtRisk': 387, 'otherNumAffected': 48, 'seriousNumAtRisk': 387, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks', 'otherNumAtRisk': 385, 'otherNumAffected': 47, 'seriousNumAtRisk': 385, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks', 'otherNumAtRisk': 389, 'otherNumAffected': 46, 'seriousNumAtRisk': 389, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'ARTERIOSCLEROSIS CORONARY ARTERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BILE DUCT STONE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEPATOBILIARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RADIUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SUBARACHNOID HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.21', 'spread': '0.702', 'groupId': 'OG000'}, {'value': '-20.18', 'spread': '0.704', 'groupId': 'OG001'}, {'value': '-13.20', 'spread': '0.700', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.44', 'spread': '0.445', 'groupId': 'OG000'}, {'value': '-14.99', 'spread': '0.445', 'groupId': 'OG001'}, {'value': '-8.78', 'spread': '0.462', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.76', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '-8.79', 'spread': '0.406', 'groupId': 'OG001'}, {'value': '-5.91', 'spread': '0.404', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'A successful response in overall BP control rate was defined as msSBP \\< 140 mmHg and msDBP \\<90 mmHg.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Successful msSBP Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '63.1', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Successful msSBP response was defined as \\< 140 mmHg or ≥ 20 mmHg reduction from baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Successful msDBP Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}, {'value': '70.1', 'groupId': 'OG001'}, {'value': '60.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Successfull msDBP response was defined as \\<90 mmHg or ≥10 mmHg reduction from baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.65', 'spread': '0.295', 'groupId': 'OG000'}, {'value': '-8.44', 'spread': '0.295', 'groupId': 'OG001'}, {'value': '-5.56', 'spread': '0.307', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in maSBP and maDBP for Daytime/Nighttime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'title': 'maSBP daytime', 'categories': [{'measurements': [{'value': '-12.60', 'spread': '0.747', 'groupId': 'OG000'}, {'value': '-14.44', 'spread': '0.747', 'groupId': 'OG001'}, {'value': '-7.87', 'spread': '0.776', 'groupId': 'OG002'}]}]}, {'title': 'maSBP nighttime', 'categories': [{'measurements': [{'value': '-15.13', 'spread': '0.747', 'groupId': 'OG000'}, {'value': '-16.09', 'spread': '0.747', 'groupId': 'OG001'}, {'value': '-10.65', 'spread': '0.776', 'groupId': 'OG002'}]}]}, {'title': 'maDBP daytime', 'categories': [{'measurements': [{'value': '-7.01', 'spread': '0.506', 'groupId': 'OG000'}, {'value': '-8.00', 'spread': '0.506', 'groupId': 'OG001'}, {'value': '-4.95', 'spread': '0.526', 'groupId': 'OG002'}]}]}, {'title': 'maDBP nighttime', 'categories': [{'measurements': [{'value': '-8.82', 'spread': '0.506', 'groupId': 'OG000'}, {'value': '-9.42', 'spread': '0.506', 'groupId': 'OG001'}, {'value': '-6.79', 'spread': '0.526', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Office Pulse Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.49', 'spread': '0.471', 'groupId': 'OG000'}, {'value': '-11.30', 'spread': '0.472', 'groupId': 'OG001'}, {'value': '-7.34', 'spread': '0.470', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.79', 'spread': '0.208', 'groupId': 'OG000'}, {'value': '-6.57', 'spread': '0.207', 'groupId': 'OG001'}, {'value': '-3.20', 'spread': '0.216', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'OG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'OG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'classes': [{'title': 'Adverse Events (serious and non-serious)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}]}, {'title': 'Seroius Adverse Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Participants were monitored for adverse events, serious adverse events and deaths throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set. The safety set included aqll participants who had received study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'FG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'FG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '387'}, {'groupId': 'FG001', 'numSubjects': '385'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '371'}, {'groupId': 'FG001', 'numSubjects': '371'}, {'groupId': 'FG002', 'numSubjects': '363'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'The study consisted of 3 epochs: 1)screening, 2) single blind run-in and 3) double blind treatment. During the run-in epoch, eligible participants received placebo to both treatments for 2 to 4 weeks. After the run-in epoch, a total of 1161 eligible participants continued into the double blind treatment epoch for 8 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}, {'value': '1161', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks'}, {'id': 'BG001', 'title': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks'}, {'id': 'BG002', 'title': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '10.87', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '10.50', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '10.50', 'groupId': 'BG002'}, {'value': '58.7', 'spread': '10.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}, {'value': '818', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-25', 'studyFirstSubmitDate': '2012-05-13', 'resultsFirstSubmitDate': '2015-07-11', 'studyFirstSubmitQcDate': '2012-05-13', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-11', 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.'}, {'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.'}, {'measure': 'Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8', 'timeFrame': '8 weeks', 'description': 'A successful response in overall BP control rate was defined as msSBP \\< 140 mmHg and msDBP \\<90 mmHg.'}, {'measure': 'Percentage of Participants Achieving a Successful msSBP Response', 'timeFrame': '8 weeks', 'description': 'Successful msSBP response was defined as \\< 140 mmHg or ≥ 20 mmHg reduction from baseline.'}, {'measure': 'Percentage of Participants Achieving a Successful msDBP Response', 'timeFrame': '8 weeks', 'description': 'Successfull msDBP response was defined as \\<90 mmHg or ≥10 mmHg reduction from baseline.'}, {'measure': 'Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8', 'timeFrame': 'Baseline, 8 weeks', 'description': 'ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.'}, {'measure': 'Change From Baseline in maSBP and maDBP for Daytime/Nighttime', 'timeFrame': 'Baseline, 8 weeks', 'description': 'ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.'}, {'measure': 'Change From Baseline in Office Pulse Pressure', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.'}, {'measure': 'Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.'}, {'measure': 'Number of Patients With Adverse Events, Serious Adverse Events and Death', 'timeFrame': '8 weeks', 'description': 'Participants were monitored for adverse events, serious adverse events and deaths throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Essential hypertension', 'LCZ696'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '37026551', 'type': 'DERIVED', 'citation': 'Kario K, Rakugi H, Yarimizu D, Morita Y, Eguchi S, Iekushi K. Twenty-Four-Hour Blood Pressure-Lowering Efficacy of Sacubitril/Valsartan Versus Olmesartan in Japanese Patients With Essential Hypertension Based on Nocturnal Blood Pressure Dipping Status: A Post Hoc Analysis of Data From a Randomized, Double-Blind Multicenter Study. J Am Heart Assoc. 2023 Apr 18;12(8):e027612. doi: 10.1161/JAHA.122.027612. Epub 2023 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 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 treatments within 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and \\< 180 mmHg at the randomization visit (Visit 201) and msSBP ≥140 mmHg \\< 180 mmHg at the visit immediately proceeding Visit 201 (Visit 102 or 103).\n* Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and \\< 180 mmHg at both Visit 1 and Visit 201.\n* Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit;\n\nExclusion Criteria:\n\n* Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg).\n* History of angioedema, drug-related or otherwise, as reported by the patient.\n* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.\n* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01599104', 'briefTitle': 'Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'CLCZ696A1306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCZ696 200 mg', 'description': 'LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks', 'interventionNames': ['Drug: LCZ696', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LCZ696 400 mg', 'description': 'LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks', 'interventionNames': ['Drug: LCZ696', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olmesartan 20 mg', 'description': 'Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks', 'interventionNames': ['Drug: Olmesartan', 'Drug: Placebo']}], 'interventions': [{'name': 'LCZ696', 'type': 'DRUG', 'description': '200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily', 'armGroupLabels': ['LCZ696 200 mg', 'LCZ696 400 mg']}, {'name': 'Olmesartan', 'type': 'DRUG', 'description': 'Olmesartan 20 mg capsule one daily', 'armGroupLabels': ['Olmesartan 20 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to LCZ696 or Olmesartan', 'armGroupLabels': ['LCZ696 200 mg', 'LCZ696 400 mg', 'Olmesartan 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '296-8602', 'city': 'Kamogawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.0969, 'lon': 140.1003}}, {'zip': '811-1244', 'city': 'Chikushi-gun', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis 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