Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01134393
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2010-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548840', 'term': 'telmisartan amlodipine combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. 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': {'timeFrame': '12 weeks: From drug administration until end of treatment plus one day.', 'eventGroups': [{'id': 'EG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination', 'otherNumAtRisk': 501, 'otherNumAffected': 26, 'seriousNumAtRisk': 501, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'T80/A10', 'description': 'Telmisartan 80 mg plus Amlodipine 10 mg once daily', 'otherNumAtRisk': 232, 'otherNumAffected': 41, 'seriousNumAtRisk': 232, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 232, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '63.3', 'upperLimit': '71.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Achieving BP control is defined as SBP\\<140 mmHg and DBP\\<90 mmHg.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.'}, {'type': 'SECONDARY', 'title': 'BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 and 8 weeks', 'description': 'Achieving BP control is defined as SBP\\<140 mmHg and DBP\\<90 mmHg.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and LOCF'}, {'type': 'SECONDARY', 'title': 'BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Morning', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}, {'title': 'Evening', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Achieving BP control with HBPM is defined as SBP\\<135 mmHg and DBP\\<85 mmHg.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and LOCF and with at least one post baseline HBPM measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Change at week 4 SBP (N=485)', 'categories': [{'measurements': [{'value': '-13.58', 'spread': '11.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 8 SBP (N=487)', 'categories': [{'measurements': [{'value': '-16.37', 'spread': '12.34', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 12 SBP (N=487)', 'categories': [{'measurements': [{'value': '-16.92', 'spread': '12.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 4 DBP (N=485)', 'categories': [{'measurements': [{'value': '-8.24', 'spread': '8.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 8 DBP (N=487)', 'categories': [{'measurements': [{'value': '-10.33', 'spread': '8.88', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 12 DBP (N=487)', 'categories': [{'measurements': [{'value': '-10.43', 'spread': '8.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 4, 8 and 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with non-missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Change at week 4 (N=482)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '9.22', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 8 (N=463)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '9.21', 'groupId': 'OG000'}]}]}, {'title': 'Change at week 12 (N=344)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '9.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS) with non-missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'timeFrame': 'weeks 4, 8 and 12', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no information in the Case Report Form (CRF)'}, {'type': 'SECONDARY', 'title': 'DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Week 4 DBP control', 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 DBP control', 'categories': [{'measurements': [{'value': '368', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 DBP control', 'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 SBP control', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 SBP control', 'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 SBP control', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 DBP response', 'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 DBP response', 'categories': [{'measurements': [{'value': '393', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 DBP response', 'categories': [{'measurements': [{'value': '399', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 SBP response', 'categories': [{'measurements': [{'value': '337', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 SBP response', 'categories': [{'measurements': [{'value': '388', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 SBP response', 'categories': [{'measurements': [{'value': '393', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'DBP control is defined as DBP \\<90 mmHg or \\<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \\<140 mmHg or \\<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \\<90 mmHg or \\<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \\>=10mmHg. SBP response is defined as SBP\\<140 mmHg or \\<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \\>=15mmHg.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and LOCF'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Blood Pressure Categories Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'BP optimal at week 4 (N=482)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'BP normal at week 4 (N=482)', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}]}]}, {'title': 'BP high-normal at week 4 (N=482)', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1 hypertension at week 4 (N=482)', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2 hypertension at week 4 (N=482)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 hypertension at week 4 (N=482)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'BP optimal at week 8 (N=487)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'BP normal at week 8 (N=487)', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}]}]}, {'title': 'BP high-normal at week 8 (N=487)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1 hypertension at week 8 (N=487)', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2 hypertension at week 8 (N=487)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 hypertension at week 8 (N=487)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'BP optimal at week 12 (N=487)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'BP normal at week 12 (N=487)', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000'}]}]}, {'title': 'BP high-normal at week 12 (N=487)', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1 hypertension at week 12 (N=487)', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2 hypertension at week 12 (N=487)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 hypertension at week 12 (N=487)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'BP optimal: SBP \\<120 mmHg and DBP \\<80 mmHg, BP normal: SBP \\<130 mmHg and DBP \\<85 mmHg but not optimal, BP high-normal: SBP \\<140 mmHg and DBP \\<90 mmHg but not normal. Grade 1 hypertension: SBP \\<160 mmHg and DBP \\<100 mmHg but not high-normal, Grade 2 hypertension: SBP \\<180 mmHg and DBP \\<110 mmHg but not grade 1, Grade 3 hypertension: SBP \\>=180 mmHg or DBP \\>=110 mmHg.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with non-missing data'}, {'type': 'SECONDARY', 'title': 'DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'DBP control morning at week 4', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}]}]}, {'title': 'DBP control morning at week 8', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}]}]}, {'title': 'DBP control morning at week 12', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}]}]}, {'title': 'DBP control evening at week 4', 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000'}]}]}, {'title': 'DBP control evening at week 8', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}, {'title': 'DBP control evening at week 12', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}]}]}, {'title': 'SBP control morning at week 4', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'SBP control morning at week 8', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'SBP control morning at week 12', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'SBP control evening at week 4', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'SBP control evening at week 8', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}]}]}, {'title': 'SBP control evening at week 12', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'DBP response morning at week 4 (N=354)', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}]}]}, {'title': 'DBP response morning at week 8 (N=354)', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}]}]}, {'title': 'DBP response morning at week 12 (N=354)', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}]}]}, {'title': 'DBP response evening at week 4 (N=354)', 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000'}]}]}, {'title': 'DBP response evening at week 8 (N=354)', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}, {'title': 'DBP response evening at week 12 (N=354)', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}]}]}, {'title': 'SBP response morning at week 4 (N=299)', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'SBP response morning at week 8 (N=299)', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'SBP response morning at week 12 (N=299)', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'SBP response evening at week 4 (N=299)', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'SBP response evening at week 8 (N=299)', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}]}]}, {'title': 'SBP response evening at week 12 (N=299)', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'DBP control: DBP \\<85 mmHg, SBP control: SBP \\<135 mmHg, DBP response: DBP \\<85 mmHg or a reduction from baseline \\>=10 mmHg, SBP response: SBP \\<135 mmHg or a reduction from baseline \\>= 15 mmHg', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and LOCF and with at least one post baseline HBPM measurement'}, {'type': 'SECONDARY', 'title': 'Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Week 4 (n=482)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=284)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4 and 8', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Entered and treated.', 'groupId': 'FG000', 'numSubjects': '501'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed trial medication.', 'groupId': 'FG000', 'numSubjects': '449'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'This was a prospective, single-arm, open-label, uncontrolled, multi-centre, international trial. Whilst 542 patients were enrolled, 502 entered the study. Since one patient refused to take study medication, only 501 patients were treated. The Full analysis set (FAS) consisted of 494 patients and this is the basis of most data presentations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '207', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '287', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic Blood Pressure (SBP) at time of baseline', 'classes': [{'categories': [{'measurements': [{'value': '151.4', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure (DBP) at time of baseline', 'classes': [{'categories': [{'measurements': [{'value': '91.8', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2010-05-28', 'resultsFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2010-06-01', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-31', 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.', 'timeFrame': '12 weeks', 'description': 'Achieving BP control is defined as SBP\\<140 mmHg and DBP\\<90 mmHg.'}], 'secondaryOutcomes': [{'measure': 'BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.', 'timeFrame': '4 and 8 weeks', 'description': 'Achieving BP control is defined as SBP\\<140 mmHg and DBP\\<90 mmHg.'}, {'measure': 'BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).', 'timeFrame': 'Week 12', 'description': 'Achieving BP control with HBPM is defined as SBP\\<135 mmHg and DBP\\<85 mmHg.'}, {'measure': 'Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP', 'timeFrame': 'weeks 4, 8 and 12'}, {'measure': 'Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.'}, {'measure': 'Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure', 'timeFrame': 'weeks 4, 8 and 12'}, {'measure': 'DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'DBP control is defined as DBP \\<90 mmHg or \\<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \\<140 mmHg or \\<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \\<90 mmHg or \\<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \\>=10mmHg. SBP response is defined as SBP\\<140 mmHg or \\<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \\>=15mmHg.'}, {'measure': 'Percentage of Patients in Blood Pressure Categories Over Time', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'BP optimal: SBP \\<120 mmHg and DBP \\<80 mmHg, BP normal: SBP \\<130 mmHg and DBP \\<85 mmHg but not optimal, BP high-normal: SBP \\<140 mmHg and DBP \\<90 mmHg but not normal. Grade 1 hypertension: SBP \\<160 mmHg and DBP \\<100 mmHg but not high-normal, Grade 2 hypertension: SBP \\<180 mmHg and DBP \\<110 mmHg but not grade 1, Grade 3 hypertension: SBP \\>=180 mmHg or DBP \\>=110 mmHg.'}, {'measure': 'DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements', 'timeFrame': 'weeks 4, 8 and 12', 'description': 'DBP control: DBP \\<85 mmHg, SBP control: SBP \\<135 mmHg, DBP response: DBP \\<85 mmHg or a reduction from baseline \\>=10 mmHg, SBP response: SBP \\<135 mmHg or a reduction from baseline \\>= 15 mmHg'}, {'measure': 'Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time', 'timeFrame': 'weeks 4 and 8'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.', 'detailedDescription': 'Study Design:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation\n2. Age 18 years or older\n3. Patients with uncontrolled hypertension as defined SBP \\> 140 mmHg and SBP \\> 130 mmHg in patients with diabetes or renal impairment or DBP \\> 90 mmHg and DBP \\>80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine \\>133µmol/l (1.5mg/dl) in male patients and a creatinine \\>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min\n\nExclusion criteria:\n\n1. Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.\n2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).\n3. Mean in-clinic seated cuff Systolic BP \\>180 mmHg and SBP \\>160 mmHg in patients with diabetes or renal impairment or Diastolic BP \\>110 mmHg and DBP \\>100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine \\>133µmol/l (1.5mg/dl) in male patients and a creatinine \\>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.\n4. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \\>3.0 mg/dl (or \\>265 ¿mol/L) and/or known creatinine clearance of \\<30 ml/min and/or clinical markers of severe renal impairment.\n5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.\n6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., \\<3.5 or \\>5.5 mEq/L).\n7. Uncorrected sodium or volume depletion.\n8. Primary aldosteronism.\n9. Hereditary fructose intolerance.\n10. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1).\n11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.\n12. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of \\>2x bilirubin or \\>2x transaminases values). (Refer to Appendix 10.3)\n13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.\n14. History of drug or alcohol dependency within six months prior to signing the informed consent form.\n15. Any investigational drug therapy within one month of signing the informed consent.\n16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).\n17. History of non-compliance or inability to comply with prescribed medications or protocol procedures.\n18. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.'}, 'identificationModule': {'nctId': 'NCT01134393', 'briefTitle': 'TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."', 'orgStudyIdInfo': {'id': '1235.33'}, 'secondaryIdInfos': [{'id': '2009-017336-40', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'telmisartan/amlodipine', 'description': 'start low dose and uptitrate to high dose on the basis of blood pressure goal', 'interventionNames': ['Drug: telmisartan/amlodipine']}], 'interventions': [{'name': 'telmisartan/amlodipine', 'type': 'DRUG', 'description': 'start low dose and uptitrate to high dose on the basis of BP goal', 'armGroupLabels': ['telmisartan/amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': '1235.33.49010 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': '1235.33.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Haag', 'country': 'Germany', 'facility': '1235.33.49007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.30379, 'lon': 12.07614}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': '1235.33.49003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Künzing', 'country': 'Germany', 'facility': '1235.33.49005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 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