Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT01103960
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5 mg one daily', 'otherNumAtRisk': 164, 'otherNumAffected': 0, 'seriousNumAtRisk': 164, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'T80/A5', 'description': 'Telmisartan 80 mg plus Amlodipine 5 mg once daily', 'otherNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in DBP After 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.19', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '-12.38', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.1881', 'ciLowerLimit': '0.6082', 'ciUpperLimit': '3.7681', 'pValueComment': 'This was the first step in the closed testing procedure of multiple endpoints. The p-value was \\<0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8030', 'groupDescription': 'A5 minus T80/A5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.85', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-10.77', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.9195', 'ciLowerLimit': '0.1443', 'ciUpperLimit': '3.6947', 'pValueComment': 'This was the second step in the closed testing procedure of multiple endpoints. The p-value was again \\<0.05 so this test was also considered confirmatory.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9015', 'groupDescription': 'A5 minus T80/A5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with LOCF and further restricted to the Chinese subgroup'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SBP After 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.66', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-16.15', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '4.4879', 'ciLowerLimit': '2.2807', 'ciUpperLimit': '6.6950', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1217', 'groupDescription': 'A5 minus T80/A5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with LOCF'}, {'type': 'SECONDARY', 'title': 'DBP and SBP Control and Response After 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'DBP control', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'SBP control', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'DBP response', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'SBP response', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 8 weeks', '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 with LOCF'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Blood Pressure Categories Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'BP optimal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'BP normal', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'BP high-normal', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1 hypertension', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2 hypertension', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 hypertension', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', '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': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DBP After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.51', 'spread': '6.80', 'groupId': 'OG000'}, {'value': '-9.41', 'spread': '7.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Seated trough DBP after 4 weeks.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SBP After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.19', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '-12.10', 'spread': '11.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Seated trough SBP after 4 weeks.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with LOCF'}, {'type': 'SECONDARY', 'title': 'DBP and SBP Control and Response After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'DBP control', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'SBP control', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'DBP response', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'SBP response', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 weeks', '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 with LOCF'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Blood Pressure Categories at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'BP optimal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'BP normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'BP high-normal', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1 hypertension', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2 hypertension', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 hypertension', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', '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': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with LOCF'}, {'type': 'SECONDARY', 'title': 'Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'OG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'classes': [{'title': 'Atrial fibrilation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial ischaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood glucose increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Protein urine present', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood creatinine phosphokinase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood glucose abnormal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From drug administration until end of treatment plus one day', 'description': 'Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'FG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised and treated.', 'groupId': 'FG000', 'numSubjects': '164'}, {'comment': 'Randomised and treated.', 'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed study medication.', 'groupId': 'FG000', 'numSubjects': '159'}, {'comment': 'Completed study medication.', 'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Whilst there were 324 patients randomised and treated, there were only 314 in the Full analysis set (FAS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A5 Alone', 'description': 'Amlodipine 5mg monotherapy'}, {'id': 'BG001', 'title': 'T80/A5', 'description': 'Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '52.4', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diastolic blood pressure (DBP)', 'classes': [{'categories': [{'measurements': [{'value': '97.84', 'spread': '6.43', 'groupId': 'BG000'}, {'value': '97.21', 'spread': '5.46', 'groupId': 'BG001'}, {'value': '97.53', 'spread': '5.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure (SBP)', 'classes': [{'categories': [{'measurements': [{'value': '146.27', 'spread': '11.15', 'groupId': 'BG000'}, {'value': '146.44', 'spread': '12.20', 'groupId': 'BG001'}, {'value': '146.35', 'spread': '11.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2010-04-13', 'resultsFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-21', 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in DBP After 8 Weeks of Treatment', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.'}, {'measure': 'Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in SBP After 8 Weeks of Treatment', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.'}, {'measure': 'DBP and SBP Control and Response After 8 Weeks of Treatment', 'timeFrame': 'Baseline and 8 weeks', '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': 'Number of Patients in Blood Pressure Categories Over Time', 'timeFrame': '8 weeks', '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': 'Change From Baseline in DBP After 4 Weeks of Treatment', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Seated trough DBP after 4 weeks.'}, {'measure': 'Change From Baseline in SBP After 4 Weeks of Treatment', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Seated trough SBP after 4 weeks.'}, {'measure': 'DBP and SBP Control and Response After 4 Weeks of Treatment', 'timeFrame': 'Baseline and 4 weeks', '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': 'Number of Patients in Blood Pressure Categories at 4 Weeks', 'timeFrame': '4 weeks', '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': 'Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.', 'timeFrame': 'From drug administration until end of treatment plus one day', 'description': 'Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '24391142', 'type': 'DERIVED', 'citation': 'Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. diagnosis of essential hypertension\n2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy\n3. provision of written informed consent\n\nExclusion criteria:\n\n1\\. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)'}, 'identificationModule': {'nctId': 'NCT01103960', 'briefTitle': 'An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy', 'orgStudyIdInfo': {'id': '1235.29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan80mg+Amlodipine5mg', 'description': 'combination therapy', 'interventionNames': ['Drug: Telmisartan80mg+Amlodipine5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'amlodipine 5 mg', 'description': 'Monotherapy', 'interventionNames': ['Drug: amlodipine 5mg', 'Drug: Telmisartan80mg+Amlodipine 5mg']}], 'interventions': [{'name': 'Telmisartan80mg+Amlodipine5mg', 'type': 'DRUG', 'description': 'combination therapy', 'armGroupLabels': ['Telmisartan80mg+Amlodipine5mg']}, {'name': 'amlodipine 5mg', 'type': 'DRUG', 'description': 'monotherapy', 'armGroupLabels': ['amlodipine 5 mg']}, {'name': 'Telmisartan80mg+Amlodipine 5mg', 'type': 'DRUG', 'description': 'combination therapy', 'armGroupLabels': ['amlodipine 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': '1235.29.86001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': '1235.29.86004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': '1235.29.86006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Changsha', 'country': 'China', 'facility': '1235.29.86013 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Guangzhou', 'country': 'China', 'facility': '1235.29.86014 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'facility': '1235.29.86012 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'country': 'China', 'facility': '1235.29.86002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': '1235.29.86009 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': '1235.29.86010 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': '1235.29.86011 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'facility': '1235.29.86007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Tianjin', 'country': 'China', 'facility': '1235.29.86008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Johor Bahru', 'country': 'Malaysia', 'facility': '1235.29.60017 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 1.4655, 'lon': 103.7578}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': '1235.29.60016 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Metro Manila', 'country': 'Philippines', 'facility': '1235.29.63018 Boehringer Ingelheim Investigational Site'}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': '1235.29.63019 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}