Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT02517866
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557413', 'term': 'azilsartan medoxomil'}, {'id': 'C521273', 'term': 'azilsartan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse Events are reported as per dose received.', 'eventGroups': [{'id': 'EG000', 'title': 'Before Week 6 Azilsartan Medoxomil 40 mg', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 6 weeks.', 'otherNumAtRisk': 380, 'otherNumAffected': 0, 'seriousNumAtRisk': 380, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'After Week 6 Azilsartan Medoxomil 40 mg', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for Week 6 up to Week 12.', 'otherNumAtRisk': 258, 'otherNumAffected': 0, 'seriousNumAtRisk': 258, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'After Week 6 Azilsartan Medoxomil 80 mg', 'description': 'Azilsartan medoxomil 80 mg, tablets, orally, once, daily, for Week 6 up to Week 12.', 'otherNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'groupId': 'OG000', 'lowerLimit': '43.40', 'upperLimit': '63.08'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '44.07', 'upperLimit': '75.70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using last observation carried forward (LOCF) method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': 'Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '45.36', 'upperLimit': '71.12'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '39.75', 'upperLimit': '65.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000', 'lowerLimit': '44.83', 'upperLimit': '68.92'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000', 'lowerLimit': '44.73', 'upperLimit': '69.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '45.97', 'upperLimit': '89.46'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '43.81', 'upperLimit': '97.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': 'Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '14.73', 'upperLimit': '36.50'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '15.73', 'upperLimit': '37.10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '10.05', 'upperLimit': '33.20'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000', 'lowerLimit': '12.18', 'upperLimit': '37.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '21.13', 'upperLimit': '65.05'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000', 'lowerLimit': '29.12', 'upperLimit': '73.67'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '57.57', 'upperLimit': '75.78'}, {'value': '70.6', 'groupId': 'OG001', 'lowerLimit': '52.49', 'upperLimit': '83.94'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '64.86', 'upperLimit': '81.66'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '67.40', 'upperLimit': '91.05'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DBP <90 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '85.11', 'upperLimit': '95.34'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '79.97', 'upperLimit': '96.46'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BP <130/80 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '17.01', 'upperLimit': '37.26'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '18.66', 'upperLimit': '48.66'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SBP <130 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000', 'lowerLimit': '22.25', 'upperLimit': '43.20'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '20.17', 'upperLimit': '50.31'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DBP <80 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '36.82', 'upperLimit': '59.95'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '41.33', 'upperLimit': '75.07'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BP <140/90 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'OG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '52.51', 'upperLimit': '71.04'}, {'value': '68.2', 'groupId': 'OG001', 'lowerLimit': '48.42', 'upperLimit': '79.92'}, {'value': '0.0', 'comment': 'CI was not calculated as there was only one participant in this group.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trough Sitting SBP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.1', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as there was only one participant who was evaluated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DBP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'OG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as there was only one participant who was evaluated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azilsartan Medoxomil (Switched)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.'}, {'id': 'FG001', 'title': 'Azilsartan Medoxomil (Add-On)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.'}, {'id': 'FG002', 'title': 'Azilsartan Medoxomil (Treatment-Naïve)', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Significant Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 34 investigative sites in Hong Kong, Taiwan and Thailand from 13 July 2015 to 25 November 2016.', 'preAssignmentDetails': 'Participants with a diagnosis of essential hypertension and type 2 diabetes mellitus (T2DM) were enrolled to receive azilsartan medoxomil at a starting dose of 40 mg increased to 80 mg if blood pressure of \\<140/85 mmHg was not achieved at Week 6.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Azilsartan Medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61.6', 'spread': '9.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'title': '< 65 years old', 'measurements': [{'value': '221', 'groupId': 'BG000'}]}, {'title': '>=65 to <75 years old', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '380', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan, Province Of China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}, {'title': 'Hong Kong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '161.1', 'spread': '9.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.04', 'spread': '15.072', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed is the number of participants who were evaluated for weight at baseline.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.64', 'spread': '4.354', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed is the number of participants who were evaluated for BMI at baseline.'}, {'title': 'Smoking history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'title': 'The participant has never smoked', 'measurements': [{'value': '279', 'groupId': 'BG000'}]}, {'title': 'The participant is an ex-smoker', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'The participant is a current smoker', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Antihypertensive Treatment Status', 'classes': [{'title': 'Treated with ACE inhibitor or ARB before Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}]}]}, {'title': 'Treated with CCB before Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}, {'title': 'Treated with Thiazide before Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were counted more than once according to the antihypertensive treatment status. Antihypertensive treatment includes Angiotensin Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB), Calcium Channel Blocker (CCB), Thiazides and/or other treatments.', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated Hemoglobin (HbA1c)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.875', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmoL/moL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 374 participants were evaluated for this baseline characteristic.'}], 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of azilsartan medoxomil.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2015-06-24', 'resultsFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-29', 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}], 'secondaryOutcomes': [{'measure': 'Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg', 'timeFrame': 'Up to Week 12', 'description': 'Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg', 'timeFrame': 'Up to Week 12', 'description': 'Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg', 'timeFrame': 'Weeks 6 and 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With DBP <90 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With BP <130/80 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With SBP <130 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With DBP <80 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Percentage of Participants With BP <140/90 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.'}, {'measure': 'Change From Baseline in Trough Sitting SBP at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in DBP at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants', 'timeFrame': 'Baseline and Week 12', 'description': 'At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Essential Hypertension', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.', 'detailedDescription': "The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have essential hypertension and type 2 diabetes mellitus (T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in addition to standard care for T2DM.\n\nThe study will enroll approximately 380 patients. All participants will receive azilsartan medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a participant's blood pressure (BP) has not reached BP goal of \\<140/85 mmHg at week 6, azilsartan medoxomil dose will be up-titrated to 80 mg daily.\n\nAll participants will be asked to take one tablet at the same time each day throughout the study.\n\nThis multi-center trial will be conducted in Asia. The overall time to participate in this study is 14 weeks. Participants will make multiple visits to the clinic, and will be contacted by 14 days after last dose of study drug for a follow-up assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.\n2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n3. Has type 2 diabetes mellitus (T2DM) with essential hypertension.\n4. T2DM participants are either treated by stable life style intervention or by oral antidiabetic drugs (OADs) that are stable, including no dose adjustment within 12 weeks before baseline.\n5. Is male or female and aged 18 to 75 years, inclusive.\n6. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg to \\<180 mmHg, or diastolic blood pressure ≥85 mmHg and \\<110 mmHg at screening and baseline.\n7. Has screening glycosylated hemoglobin (HbA1C) \\<9.5%.\n8. Female participants must be either of non-childbearing potential, ie, surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year after the last menstrual period; or, if of childbearing potential and participant is sexually active with a nonsterilized male partner, must agree to use routinely adequate contraception from signing of informed consent throughout the duration of study.\n\nExclusion Criteria:\n\n1. Has systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite concurrent treatment with three antihypertensive medications from different classes at adequate doses including a diuretic.\n2. Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% at screening.\n3. Is treated with OADs has not been on stable treatment including no dose change of their OADs for at least 12 weeks prior to baseline.\n4. Has been previously treated with azilsartan medoxomil (AZM) or azilsartan.\n5. Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).\n6. Has congestive heart failure (New York Heart Association class III or IV), clinically relevant cardiac arrhythmias (as determined by the investigator's clinical judgment on a participant-by-participant basis), severe obstructive coronary artery disease.\n7. Has participated in a clinical trial including interventional and observational studies, or received any investigational compound currently or 30 days prior to screening.\n8. Has severe renal impairment (based on estimated glomerular filtration rate \\[GFR\\] \\<30 mL/min/1.73m\\^2) at Screening.\n9. Has hyperkalemia defined as serum potassium \\>5.0 mEq/L.\n10. Has an alanine aminotransferase (ALT) level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening.\n11. Has any clinically relevant disease (eg malignancy, neurological, hepatic abnormalities) and/or significant abnormal laboratory findings (past or present), which, in the opinion of the investigator, may put the participant at risk because of participation in the study.\n12. Is taking prohibited medications including lithium and aliskiren (refer to Edarbi® product insert).\n13. Has known hypersensitivity to any excipients or angiotensin converting enzyme inhibitor (ACEIs)/ angiotensin receptor blockers (ARBs).\n14. Has prior angioedema due to an ACE inhibitor or ARB.\n15. Breast feeding or pregnant women or women who are intending to become pregnant before, during or within 1 month after participating in the study; or intending to donate ova during such time period, or refusal to submit to a urine test to rule out pregnancy prior to enrolment and at end of study.\n16. Have a history of alcohol abuse, drug abuse or illegal drug addiction within the 6 months prior to signing the informed consent.\n17. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress."}, 'identificationModule': {'nctId': 'NCT02517866', 'briefTitle': 'Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia', 'orgStudyIdInfo': {'id': 'AZI-P4-002'}, 'secondaryIdInfos': [{'id': 'U1111-1156-8501', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azilsartan medoxomil', 'description': 'Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \\<140/85 mmHg at Week 6.', 'interventionNames': ['Drug: Azilsartan Medoxomil']}], 'interventions': [{'name': 'Azilsartan Medoxomil', 'type': 'DRUG', 'otherNames': ['Edarbi®'], 'description': 'Azilsartan medoxomil tablets', 'armGroupLabels': ['Azilsartan medoxomil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Changhua County', 'country': 'Taiwan'}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan', 'country': 'Taiwan', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Khon Kaen', 'country': 'Thailand', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'city': 'Pathum Thani', 'country': 'Thailand', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}