Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT00553267
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2007-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
Sponsor:
Organization:
Raw JSON
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The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amlodipine 10mg', 'otherNumAffected': 22, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg', 'otherNumAffected': 21, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg', 'otherNumAffected': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Peripheral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ruptured cerebral aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Trough Seated Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.48', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-9.24', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-9.33', 'spread': '0.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.76', 'ciLowerLimit': '-3.77', 'ciUpperLimit': '-1.75', 'pValueComment': 'Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Testing that the combination treatments are superior to monotherapy A10.\n\nThe number of patients in the treatment arms ensure the tests have over 90% power.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and country effect', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.85', 'ciLowerLimit': '-3.86', 'ciUpperLimit': '-1.84', 'pValueComment': 'Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': 'Testing that the combination treatments are superior to monotherapy A10.\n\nThe number of patients in the treatment arms ensure the tests have over 90% power.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and country effect', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and end of study (8 weeks or last value on treatment)', 'description': 'Change from baseline to the end of study in trough DBP', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trough Seated Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.44', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-11.09', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '-11.29', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.66', 'ciLowerLimit': '-5.15', 'ciUpperLimit': '-2.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 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observation carried forward'}, {'type': 'SECONDARY', 'title': 'Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'title': 'Yes (DBP<90 mmHg)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}]}, {'title': 'No (DBP>=90 mmHg)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.21', 'ciUpperLimit': '2.32', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '1.37', 'ciUpperLimit': '2.65', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target DBP of \\<90mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Trough Seated Diastolic Blood Pressure <80 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'title': 'Yes (DBP<80 mmHg)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'No (DBP>=80 mmHg)', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.35', 'ciLowerLimit': '1.30', 'ciUpperLimit': '4.25', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '1.29', 'ciUpperLimit': '4.22', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target DBP of \\<80mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Trough Seated DBP Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'title': 'Yes (Responder)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}]}, {'title': 'No (Non-responder)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.21', 'ciUpperLimit': '2.34', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.38', 'ciUpperLimit': '2.68', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target DBP of \\<90mmHg or had a reduction in DBP \\>= 10mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had 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'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '1.04', 'ciUpperLimit': '2.00', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.12', 'ciUpperLimit': '2.15', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target SBP of \\<140mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Trough Seated SBP Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'title': 'Yes (Responder)', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}]}, {'title': 'No (Non-responder)', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.21', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.20', 'ciUpperLimit': '2.32', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mantel-Haenszel statistics adjusted for country effect', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target SBP of \\<140mmHg or had a reduction in SBP \\>= 15 mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Trough Seated BP Normality Classes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'title': 'Optimal (SBP<120 and DBP<80 mmHg)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Normal (SBP<130 and DBP<85 mmHg and not optimal)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'High-normal (SBP<140 DBP<90 mmHg and not normal)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Stage 1 hypertension (SBP<160 and DBP<100 mmHg)', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}, {'title': 'Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified (for country) Wilcoxon rank sum test', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified (for country) Wilcoxon rank sum test', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach predefined BP categories', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Oedema Incidence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and 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{'value': '310', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10mg'}, {'id': 'OG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'OG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '54.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment period', 'description': 'The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)', 'unitOfMeasure': 'Number of cases/100 patient-years', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amlodipine 10mg'}, {'id': 'FG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'FG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '315'}, {'groupId': 'FG002', 'numSubjects': '317'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '297'}, {'groupId': 'FG002', 'numSubjects': '307'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Non compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Specified category', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}, {'value': '947', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Amlodipine 10mg'}, {'id': 'BG001', 'title': 'Telmisartan 40mg and Amlodipine 10mg'}, {'id': 'BG002', 'title': 'Telmisartan 80mg and Amlodipine 10mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '56.5', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '419', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 947}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2007-10-08', 'resultsFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2007-11-02', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-18', 'studyFirstPostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Trough Seated Diastolic Blood Pressure', 'timeFrame': 'Baseline and end of study (8 weeks or last value on treatment)', 'description': 'Change from baseline to the end of study in trough DBP'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Trough Seated Systolic Blood Pressure', 'timeFrame': 'Baseline and end of study (8 weeks or last value on treatment)', 'description': 'Change from baseline to the end of study in trough SBP'}, {'measure': 'Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target DBP of \\<90mmHg'}, {'measure': 'Trough Seated Diastolic Blood Pressure <80 mmHg', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target DBP of \\<80mmHg'}, {'measure': 'Trough Seated DBP Response', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target DBP of \\<90mmHg or had a reduction in DBP \\>= 10mmHg'}, {'measure': 'Trough Seated SBP Control', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target SBP of \\<140mmHg'}, {'measure': 'Trough Seated SBP Response', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach the target SBP of \\<140mmHg or had a reduction in SBP \\>= 15 mmHg'}, {'measure': 'Trough Seated BP Normality Classes', 'timeFrame': 'End of study (8 weeks or last value on treatment)', 'description': 'The number of patients who reach predefined BP categories'}, {'measure': 'Oedema Incidence Rate', 'timeFrame': 'During randomised treatment period', 'description': 'The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)'}, {'measure': 'Peripheral Oedema Incidence Rate', 'timeFrame': 'During randomised treatment period', 'description': 'The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) \\>= 95 mmHg if on existing antihypertensive treatment or seated DBP \\>= 100 mmHg if treatment-naïve).\n* failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP \\>= 90 mmHg.)\n* able to stop any current antihypertensive therapy without unacceptable risk to the patient.\n* willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).\n* known or suspected secondary hypertension.\n* mean seated systolic blood pressure (SBP) \\>=200 mmHg and/or mean seated DBP \\>= 120 mmHg during run-in treatment or mean seated SBP \\>= 180 mmHg and/or mean seated DBP \\>= 120 mmHg at the randomisation visit or at any time during randomised treatment.\n* any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.\n* clinically relevant hyperkalaemia.\n* uncorrected volume or sodium depletion.\n* primary aldosteronism.\n* hereditary fructose or lactose intolerance.\n* symptomatic congestive heart failure.\n* patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs.\n* history of drug or alcohol dependency within the six months prior to signing consent.\n* concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.\n* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.\n* known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine CCBs.)\n* non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.\n* current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.\n* chronic administration of any medication known to affect blood pressure, other than the trial medication.\n* any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.'}, 'identificationModule': {'nctId': 'NCT00553267', 'briefTitle': 'Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy', 'orgStudyIdInfo': {'id': '1235.6'}, 'secondaryIdInfos': [{'id': 'EUDRACT 2007-002421-68'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fixed dose combination of telmisartan+amlodipine', 'type': 'DRUG'}, {'name': 'amlodipine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gosford', 'state': 'New South Wales', 'country': 'Australia', 'facility': '1235.6.61003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': '1235.6.61004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'city': 'Kippa-Ring', 'state': 'Queensland', 'country': 'Australia', 'facility': '1235.6.61002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'city': 'Milton', 'state': 'Queensland', 'country': 'Australia', 'facility': '1235.6.61001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -27.47039, 'lon': 153.00312}}, {'city': 'Elizabeth Vale', 'state': 'South Australia', 'country': 'Australia', 'facility': '1235.6.61005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'city': 'Eggenburg', 'country': 'Austria', 'facility': '1235.6.43007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.63892, 'lon': 15.81903}}, {'city': 'Hainburg A.d. 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