Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 6:03 PM
Study NCT ID:
NCT00791258
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}, {'id': 'D000068558', 'term': 'Amlodipine Besylate, Olmesartan Medoxomil Drug Combination'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jraia@dsi.com', 'phone': '(973) 944-2683', 'title': 'John Raia', 'organization': 'Daiichi Sankyo, Inc'}, 'certainAgreement': {'otherDetails': 'As stated in the clinical study agreement, If identified by DSI, any of DSI\'s confidential information as defined herein shall be deleted...Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publicartion prepared by the Study Site."', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose.', 'description': "AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.", 'eventGroups': [{'id': 'EG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks', 'otherNumAtRisk': 999, 'otherNumAffected': 241, 'seriousNumAtRisk': 999, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numAffected': 103}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'depession', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'oesophageal rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Non small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'vaginal haemhorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'protate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 999, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '2.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '985', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '75.8', 'ciLowerLimit': '73.0', 'ciUpperLimit': '78.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '985', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.3', 'ciLowerLimit': '81.8', 'ciUpperLimit': '86.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '985', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.3', 'ciLowerLimit': '68.3', 'ciUpperLimit': '74.1', 'groupDescription': '12 week analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.8', 'ciLowerLimit': '82.4', 'ciUpperLimit': '87.0', 'groupDescription': '20 week analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 and 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks, N=975', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': '8 weeks, N=929', 'categories': [{'measurements': [{'value': '-16.6', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': '12 weeks, N=865', 'categories': [{'measurements': [{'value': '-21.8', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': '16 weeks, N=797', 'categories': [{'measurements': [{'value': '-26.0', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': '20 weeks, N=745', 'categories': [{'measurements': [{'value': '-26.8', 'spread': '0.53', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.6', 'ciLowerLimit': '-15.4', 'ciUpperLimit': '-13.8', 'groupDescription': '4 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '-15.7', 'groupDescription': '8 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.8', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-20.9', 'groupDescription': '12 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.0', 'ciLowerLimit': '-27.0', 'ciUpperLimit': '-25.0', 'groupDescription': '16 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.8', 'ciLowerLimit': '-27.8', 'ciUpperLimit': '-25.7', 'groupDescription': '20 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks, N=975', 'categories': [{'measurements': [{'value': '-8.1', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': '8 weeks, N=929', 'categories': [{'measurements': [{'value': '-9.1', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': '12 weeks, N=865', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': '16 weeks, N=797', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': '20 weeks, N=745', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '0.34', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '-7.6', 'groupDescription': '4 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.1', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '-8.5', 'groupDescription': '8 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.9', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '-11.4', 'groupDescription': '12 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.6', 'ciLowerLimit': '-15.2', 'ciUpperLimit': '-14.0', 'groupDescription': '16 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.5', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '-13.8', 'groupDescription': '20 week analysis', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=975', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}]}]}, {'title': '4weeks: <85 mm Hg, N=975', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=975', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=929', 'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=929', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=929', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=865', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=865', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=865', 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=797', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=797', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=797', 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=745', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=745', 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=745', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=975', 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=975', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=975', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=975', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=929', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=929', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=929', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=929', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=865', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=865', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=865', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=865', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=797', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=797', 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=797', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=797', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=745', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=745', 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=745', 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=745', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140/90 mm Hg, N=975', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135/80 mm Hg, N=975', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130/80 mm Hg, N=975', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120/80 mm Hg, N=975', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140/90 mm Hg, N=929', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135/80 mm Hg, N=929', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130/80 mm Hg, N=929', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120/80 mm Hg, N=929', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140/90 mm Hg, N=865', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135/80 mm Hg, N=865', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130/80 mm Hg, N=865', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120/80 mm Hg, N=865', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140/90mm Hg, N=797', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135/80mm Hg, N=797', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130/80mm Hg, N=797', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120/80mm Hg, N=797', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140/90 mm Hg, N=745', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135/80 mm Hg, N=745', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130/80 mm Hg, N=745', 'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120/80 mm Hg, N=745', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=975', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=975', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=975', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=975', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=929', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=929', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=929', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=929', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=865', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=865', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=865', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=865', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=797', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=797', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=797', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=797', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=745', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=745', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=745', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=745', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=975', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=975', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=975', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=975', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=929', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=929', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=929', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=929', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=865', 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤ 15 mm Hg, N=865', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=865', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=865', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=797', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=797', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=797', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=797', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=745', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=745', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=745', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=745', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Daytime mean systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '66.4', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <135/95 mmHg', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <125/75 mmHg', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <120/70 mmHg', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Daytime mean systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <135/95 mmHg', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <125/75 mmHg', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}]}]}, {'title': 'Daytime mean blood pressure <120/70 mmHg', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Nighttime mean systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <135/95 mmHg', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <125/75 mmHg', 'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <120/70 mmHg', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Nighttime mean systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <135/95 mmHg', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <125/75 mmHg', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}]}]}, {'title': 'Nighttime mean blood pressure <120/70 mmHg', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '24-hour mean systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <135/95 mmHg', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <125/75 mmHg', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <120/70 mmHg', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '24-hour mean systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <135/95 mmHg', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <125/75 mmHg', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean blood pressure <120/70 mmHg', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '24-hour mean systolic blood pressure', 'categories': [{'measurements': [{'value': '-14.8', 'spread': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Mean daytime systolic blood pressure', 'categories': [{'measurements': [{'value': '-16.3', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Mean nighttime systolic blood pressure', 'categories': [{'measurements': [{'value': '-12.5', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure - last 2 hours of dose', 'categories': [{'measurements': [{'value': '-13.6', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure - last 4 hours of dose', 'categories': [{'measurements': [{'value': '-13.0', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure - last 6 hours of dose', 'categories': [{'measurements': [{'value': '-12.6', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure', 'categories': [{'measurements': [{'value': '-9.4', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Mean daytime diastolic blood pressure', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Mean nighttime diastolic blood pressure', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure - last 2 hours of dose', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure - last 4 hours of dose', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure - last 6 hours of dose', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '0.57', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.8', 'ciLowerLimit': '-16.2', 'ciUpperLimit': '-13.4', 'groupDescription': 'Mean 24-hour systolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.3', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '-14.8', 'groupDescription': 'Mean daytime systolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '-10.8', 'groupDescription': 'Mean nighttime systolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.6', 'ciLowerLimit': '-15.7', 'ciUpperLimit': '-11.6', 'groupDescription': 'systolic blood pressure during last 2 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '-11.2', 'groupDescription': 'systolic blood pressure during last 4 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-14.3', 'ciUpperLimit': '-10.9', 'groupDescription': 'systolic blood pressure during last 6 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '-8.5', 'groupDescription': 'Mean 24-hour diastolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.6', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '-9.6', 'groupDescription': 'Mean daytime diastolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.6', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '-6.4', 'groupDescription': 'Mean nighttime diastolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '-7.2', 'groupDescription': 'diastolic blood pressure during last 2 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.0', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '-6.8', 'groupDescription': 'diastolic blood pressure during last 4 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '-6.6', 'groupDescription': 'diastolic blood pressure during last 6 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '24-hour mean systolic blood pressure', 'categories': [{'measurements': [{'value': '-21.0', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Mean daytime systolic blood pressure', 'categories': [{'measurements': [{'value': '-23.2', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Mean nighttime systolic blood pressure', 'categories': [{'measurements': [{'value': '-17.5', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure - last 2 hours of dose', 'categories': [{'measurements': [{'value': '-19.6', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure - last 4 hours of dose', 'categories': [{'measurements': [{'value': '-18.2', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure - last 6 hours of dose', 'categories': [{'measurements': [{'value': '-17.9', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': '24-hour mean diastolic blood pressure', 'categories': [{'measurements': [{'value': '-13.3', 'spread': '0.55', 'groupId': 'OG000'}]}]}, {'title': 'Mean daytime diastolic blood pressure', 'categories': [{'measurements': [{'value': '-15.0', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Mean nighttime diastolic blood pressure', 'categories': [{'measurements': [{'value': '-11.1', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure - last 2 hours of dose', 'categories': [{'measurements': [{'value': '-12.3', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure - last 4 hours of dose', 'categories': [{'measurements': [{'value': '-11.6', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure - last 6 hours of dose', 'categories': [{'measurements': [{'value': '-11.3', 'spread': '0.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.0', 'ciLowerLimit': '-22.6', 'ciUpperLimit': '-19.3', 'groupDescription': '24-hour mean systolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.2', 'ciLowerLimit': '-25.1', 'ciUpperLimit': '-21.4', 'groupDescription': 'Mean daytime systolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.5', 'ciLowerLimit': '-19.4', 'ciUpperLimit': '-15.6', 'groupDescription': 'Mean nighttime systolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.6', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '-17.4', 'groupDescription': 'Systolic blood pressure - last 2 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.2', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '-16.3', 'groupDescription': 'Systolic blood pressure - last 4 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.9', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '-16.0', 'groupDescription': 'Systolic blood pressure - last 6 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.3', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '-12.2', 'groupDescription': '24-hour mean diastolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.0', 'ciLowerLimit': '-16.2', 'ciUpperLimit': '-13.8', 'groupDescription': 'Mean daytime diastolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.1', 'ciLowerLimit': '-12.4', 'ciUpperLimit': '-9.8', 'groupDescription': 'Mean nighttime diastolic blood pressure', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.3', 'ciLowerLimit': '-13.8', 'ciUpperLimit': '-10.8', 'groupDescription': 'Diastolic blood pressure - last 2 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.6', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '-10.2', 'groupDescription': 'Diastolic blood pressure - last 4 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.3', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '-10.0', 'groupDescription': 'Diastolic blood pressure - last 6 hours of dose', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.'}, {'type': 'SECONDARY', 'title': 'Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=230', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=230', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=230', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=230', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=231', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=231', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=231', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=231', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=232', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=232', 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=232', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=232', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=232', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=232', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=232', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=232', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=232', 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=232', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=232', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=232', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=230', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=230', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=230', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=231', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=231', 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=231', 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=232', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=232', 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=232', 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=232', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=232', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=232', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140/90 mm Hg, N=230', 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135/80 mm Hg, N=230', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130/80 mm Hg, N=230', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120/80 mm Hg, N=230', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140/90 mm Hg, N=231', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135/80 mm Hg, N=231', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140/90mm Hg, N=232', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140/90 mm Hg, N=232', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140/90 mm Hg, N=232', 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120/80 mm Hg, N=232', 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=230', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=230', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=230', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=230', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=220', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=220', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=220', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=220', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=208', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=208', 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=208', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=208', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=199', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=199', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=199', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=199', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=189', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=189', 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=189', 'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=189', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=230', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=230', 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=230', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=230', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=220', 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=220', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=220', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=220', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=208', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=208', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=208', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=208', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=199', 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=199', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=199', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=199', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=189', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=189', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=189', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=189', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=128', 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=128', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=128', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=128', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=128', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=128', 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=128', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=128', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=128', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=128', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=128', 'categories': [{'measurements': [{'value': '66.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=128', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=128', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=128', 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=128', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=128', 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=128', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=128', 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=128', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=128', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=128', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=128', 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=128', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=128', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=128', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=128', 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=128', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=128', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=128', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=128', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=128', 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=128', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=128', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=128', 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=128', 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=126', 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=126', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=126', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=126', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=123', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=123', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=123', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=123', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=120', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=120', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=120', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=120', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=112', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=112', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=112', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=112', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=105', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=105', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=105', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=105', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=126', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=126', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=126', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=126', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=123', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=123', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=123', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=123', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=120', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=120', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=120', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=120', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=112', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=112', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=112', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=112', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=105', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=105', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=105', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=105', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=98', 'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=98', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=98', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=98', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=100', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=100', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=100', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=100', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=100', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=100', 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=100', 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=100', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=100', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=100', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=100', 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=100', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=100', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=100', 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=100', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=100', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=98', 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=98', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=98', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=100', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=100', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=100', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=100', 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=100', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=100', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=100', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=100', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=100', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=100', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=100', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=100', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=98', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=98', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=98', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=98', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=91', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=91', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=91', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=91', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=83', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=83', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=83', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=83', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=75', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=75', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=75', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=75', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=71', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=71', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=71', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=71', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=98', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=98', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=98', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=98', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=91', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=91', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=91', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=91', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=83', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=83', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=83', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=83', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=75', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=75', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=75', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=75', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=71', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=71', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=71', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=71', 'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=227', 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=227', 'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=227', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=227', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=227', 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=227', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=227', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=227', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=227', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=227', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=227', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=227', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=227', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=227', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=227', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=227', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=227', 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=227', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=227', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=227', 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.'}, {'type': 'SECONDARY', 'title': 'Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=227', 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=227', 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=227', 'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=227', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=227', 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=227', 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=227', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=227', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=227', 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=227', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=227', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=227', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=227', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=227', 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=227', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.'}, {'type': 'SECONDARY', 'title': 'Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=224', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=224', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=224', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=224', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=217', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=217', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=217', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=217', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=199', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=199', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=199', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=199', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=179', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=179', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=179', 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=179', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=166', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=166', 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=166', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=166', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.'}, {'type': 'SECONDARY', 'title': 'Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=224', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=224', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=224', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=224', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=217', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=217', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=217', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=217', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=199', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=199', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=199', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=199', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=179', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=179', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=179', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=179', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=166', 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=166', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=166', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=166', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.'}, {'type': 'SECONDARY', 'title': 'Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=190', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=190', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=190', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=190', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=190', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=190', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=190', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=190', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=190', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=190', 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=190', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=190', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=190', 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=190', 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=190', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=190', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=190', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=190', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=190', 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=190', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=190', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=190', 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=190', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=190', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=190', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=190', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=190', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=190', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=190', 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=190', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=190', 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=190', 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=190', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=190', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=190', 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=189', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=189', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=189', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=189', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=181', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=181', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=181', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=181', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=170', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=170', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=170', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=170', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=156', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=156', 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=156', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=156', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=150', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=150', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=150', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=150', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=189', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=189', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=189', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=189', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=181', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=181', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=181', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=181', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=170', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=170', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=170', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=170', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=156', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=156', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=156', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=156', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=150', 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=150', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=150', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=150', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.'}, {'type': 'SECONDARY', 'title': 'Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=497', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=497', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=497', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=497', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=500', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=500', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=500', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=500', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=500', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=500', 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=500', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=500', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=500', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=500', 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=500', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=500', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=500', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=500', 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=500', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=500', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2'}, {'type': 'SECONDARY', 'title': 'Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=497', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=497', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=497', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=497', 'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=500', 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=500', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=500', 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=500', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=500', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=500', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=500', 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=500', 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=500', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=500', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=500', 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2'}, {'type': 'SECONDARY', 'title': 'Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=495', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=495', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=495', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=495', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=468', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=468', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=468', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=468', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=436', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=436', 'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=436', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=436', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=400', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=400', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=400', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=400', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=379', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=379', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=379', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=379', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=495', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=495', 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=495', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=495', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=468', 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=468', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=468', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=468', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=436', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=436', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=436', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=436', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=400', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=400', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=400', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=400', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=379', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=379', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=379', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=379', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <140 mm Hg, N=454', 'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <135 mm Hg, N=454', 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <130 mm Hg, N=454', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <120 mm Hg, N=454', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <140 mm Hg, N=457', 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <135 mm Hg, N=457', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <130 mm Hg, N=457', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <120 mm Hg, N=457', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <140 mm Hg, N=457', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <135 mm Hg, N=457', 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <130 mm Hg, N=457', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <120 mm Hg, N=457', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <140 mm Hg, N=457', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <135 mm Hg, N=457', 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <130 mm Hg, N=457', 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <120 mm Hg, N=457', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <140 mm Hg, N=457', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <135 mm Hg, N=457', 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <130 mm Hg, N=457', 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <120 mm Hg, N=457', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: <90 mm Hg, N=454', 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <85 mm Hg, N=454', 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: <80 mm Hg, N=454', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <90 mm Hg, N=457', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <85 mm Hg, N=457', 'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: <80 mm Hg, N=457', 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <90 mm Hg, N=457', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <85 mm Hg, N=457', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: <80 mm Hg, N=457', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <90 mm Hg, N=457', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <85 mm Hg, N=457', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: <80 mm Hg, N=457', 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <90 mm Hg, N=457', 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <85 mm Hg, N=457', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: <80 mm Hg, N=457', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 15 mm Hg, N=453', 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 30 mm Hg, N=453', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >30 and ≤ 45 mm Hg, N=453', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >45 mm Hg, N=453', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 15 mm Hg, N=431', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 30 mm Hg, N=431', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >30 and ≤ 45 mm Hg, N=431', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >45 mm Hg, N=431', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 15 mm Hg, N=402', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 30 mm Hg, N=402', 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >30 and ≤ 45 mm Hg, N=402', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >45 mm Hg, N=402', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 15 mm Hg, N=371', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 30 mm Hg, N=371', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >30 and ≤ 45 mm Hg, N=371', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >45 mm Hg, N=371', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 15 mm Hg, N=356', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 30 mm Hg, N=356', 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >30 and ≤ 45 mm Hg, N=356', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >45 mm Hg, N=356', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': '4 weeks: ≤ 10 mm Hg, N=453', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >10 and ≤ 15 mm Hg, N=453', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >15 and ≤ 20 mm Hg, N=453', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: >20 mm Hg, N=453', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: ≤ 10 mm Hg, N=431', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >10 and ≤ 15 mm Hg, N=431', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >15 and ≤ 20 mm Hg, N=431', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: >20 mm Hg, N=431', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: ≤ 10 mm Hg, N=402', 'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >10 and ≤15 mm Hg, N=402', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >15 and ≤ 20 mm Hg, N=402', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks: >20 mm Hg, N=402', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: ≤ 10 mm Hg, N=371', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >10 and ≤ 15 mm Hg, N=371', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >15 and ≤ 20 mm Hg, N=371', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}]}]}, {'title': '16 weeks: >20 mm Hg, N=371', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: ≤ 10 mm Hg, N=356', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >10 and ≤ 15 mm Hg, N=356', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >15 and ≤ 20 mm Hg, N=356', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}]}]}, {'title': '20 weeks: >20 mm Hg, N=356', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '59.8', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'classes': [{'title': 'Systolic blood pressure <140 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <135 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <130 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure <120 mmHg', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <85 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure <80 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <140/90 mmHg', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <135/80 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <130/80 mmHg', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood pressure <120/80 mmHg', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '999'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '736'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Did not take medication for >3 days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'subject left area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Subject incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject required restricted medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occurred at approximately 140 outpatient medical clinics in the United States and South Africa from December 2008 through March 2009. 1406 uncontrolled hypertensive subjects were screened to place 999 subjects into active treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '999', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide', 'description': 'Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '771', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '491', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '508', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '234', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '630', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '732', 'groupId': 'BG000'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hispanic or Latino', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}, {'title': 'Non-Hispanic or Latino', 'categories': [{'measurements': [{'value': '894', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Type 2 Diabetes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '807', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '88.20', 'spread': '21.466', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.02', 'spread': '6.370', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m٨2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metabolic syndrome', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '462', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '537', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Metabolic syndrome is defined as having at least 3 of the following parameters: waist circumference ≥40 inches (males) or ≥35 inches (females); triglycerides ≥150 mg/dL; high density lipoprotein cholesterol \\<40 mg/dL (males) or \\<50 mg/dL (females); blood pressure ≥130/85 mmHg; fasting glucose ≥100mg/dL; BMI ≥30kg/m2.', 'unitOfMeasure': 'Participants'}, {'title': 'Mean seated systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '153.66', 'spread': '9.178', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean seated diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '91.92', 'spread': '8.616', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulse rate', 'classes': [{'categories': [{'measurements': [{'value': '74.77', 'spread': '11.621', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-Hour mean systolic ambulatory blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '135.74', 'spread': '11.698', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-Hour mean diastolic ambulatory blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '81.09', 'spread': '9.346', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 999}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2008-11-13', 'resultsFirstSubmitDate': '2010-09-02', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-09-02', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks', 'timeFrame': 'baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks', 'timeFrame': 'baseline to 12 weeks'}, {'measure': 'The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks', 'timeFrame': 'Baseline to 12 and 20 weeks'}, {'measure': 'Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.'}, {'measure': 'Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.'}, {'measure': 'Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.'}, {'measure': 'Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.'}, {'measure': 'Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.'}, {'measure': 'Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.'}, {'measure': 'Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.'}, {'measure': 'Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.'}, {'measure': 'Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks', 'timeFrame': 'Baseline to 4, 8, 12, 16, 20 weeks'}, {'measure': 'Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks'}, {'measure': 'Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks'}, {'measure': 'Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks'}, {'measure': 'Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks'}, {'measure': 'Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks'}, {'measure': 'Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks', 'timeFrame': 'Baseline to 20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '23254596', 'type': 'DERIVED', 'citation': 'Nesbitt SD, Shojaee A, Maa JF, Weir MR. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens. 2013 Jul;27(7):445-52. doi: 10.1038/jhh.2012.65. Epub 2012 Dec 20.'}, {'pmid': '23072496', 'type': 'DERIVED', 'citation': 'Hsueh WA, Shojaee A, Maa JF, Neutel JM. Efficacy of amlodipine/olmesartan medoxomil +/- HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Curr Med Res Opin. 2012 Nov;28(11):1809-18. doi: 10.1185/03007995.2012.740632. Epub 2012 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= to 18 years of age\n* Hypertension uncontrolled on current monotherapy\n* Females:\n* negative serum pregnancy test at screening\n* post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control\n\nExclusion Criteria:\n\n* Pregnant females\n* Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene\n* Diabetes requiring insulin\n* Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment\n* History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months\n* History of Class III or IV congestive heart failure\n* History of stroke or transient ischemic attack within the last 1 year'}, 'identificationModule': {'nctId': 'NCT00791258', 'acronym': 'BP CRUSH', 'briefTitle': 'A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy', 'orgStudyIdInfo': {'id': 'CS8663-404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks', 'interventionNames': ['Drug: amlodipine and olmesartan medoxomil tablets', 'Drug: hydrochlorothiazide tablets']}], 'interventions': [{'name': 'amlodipine and olmesartan medoxomil tablets', 'type': 'DRUG', 'otherNames': ['AZOR Tablets'], 'description': 'amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks', 'armGroupLabels': ['1']}, {'name': 'hydrochlorothiazide tablets', 'type': 'DRUG', 'description': 'hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Green Valley', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 31.85425, 'lon': -110.9937}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Sierra Vista', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 31.55454, 'lon': -110.30369}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Harbor City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.79002, 'lon': -118.29785}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'Tustin', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'city': 'Milford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.22232, 'lon': -73.0565}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'city': 'Orland Park', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.63031, 'lon': -87.85394}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}, {'city': 'Oxon Hill', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.80345, 'lon': -76.9897}}, {'city': 'Reisterstown', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.46976, 'lon': -76.8319}}, {'city': 'Stevensville', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.01449, 'lon': -86.51947}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'city': 'Sewell', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.7665, 'lon': -75.14434}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Harrisburg', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.32395, 'lon': -80.65784}}, {'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Havertown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.98095, 'lon': -75.30852}}, {'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'New Tazewell', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.44258, 'lon': -83.59963}}, {'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Walla Walla', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 46.06458, 'lon': -118.34302}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Integrium', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Diector of Medical Research and Strategy', 'oldOrganization': 'Daiichi Sankyo'}}}}