Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-31 @ 9:14 AM
Study NCT ID:
NCT01243268
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected during the surveillance period (19 Aug 2010 to 18 Aug 2016); up to 313 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.', 'otherNumAtRisk': 610, 'otherNumAffected': 0, 'seriousNumAtRisk': 610, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.95', 'groupId': 'OG000', 'lowerLimit': '71.04', 'upperLimit': '78.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects who had achieved normal blood pressure (SBP/DBP \\< 140/90 millimeters of mercury (mmHg))is presented', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'classes': [{'title': 'Short term surveillance', 'categories': [{'measurements': [{'value': '3.28', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '6.36'}]}]}, {'title': 'Long term surveillance', 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '10.70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)', 'description': 'Percentage of subjects with adverse events is presented. Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.45', 'groupId': 'OG000', 'lowerLimit': '86.52', 'upperLimit': '91.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects who achieved DBP response (defined as mean sitting DBP \\< 90 mmHg or a reduction of over 10 mmHg) is presented', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.76', 'groupId': 'OG000', 'lowerLimit': '84.67', 'upperLimit': '90.42'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects who achieved SBP response (defined as mean sitting SBP \\< 140 mmHg or a reduction of over 10 mmHg) is presented', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.53', 'groupId': 'OG000', 'lowerLimit': '31.04', 'upperLimit': '48.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP \\< 130/80 mmHg is presented', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '674'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '610'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'Deviation with contract date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Duplicate subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Case report forms of subjects were retrieved from 34 investigators at 26 institutions', 'preAssignmentDetails': 'The study initiated on Dec 21, 2010, but the local health authority fixed the study period as August 19, 2010 to August 18, 2016'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Twynsta® Tablets', 'description': 'Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water.\n\nTwynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.96', 'spread': '12.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '271', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '339', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 674}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-14', 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Adverse Events', 'timeFrame': 'Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)', 'description': 'Percentage of subjects with adverse events is presented. Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects who had achieved normal blood pressure (SBP/DBP \\< 140/90 millimeters of mercury (mmHg))is presented'}, {'measure': 'Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects who achieved DBP response (defined as mean sitting DBP \\< 90 mmHg or a reduction of over 10 mmHg) is presented'}, {'measure': 'Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects who achieved SBP response (defined as mean sitting SBP \\< 140 mmHg or a reduction of over 10 mmHg) is presented'}, {'measure': 'Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.', 'timeFrame': '8±2 weeks', 'description': 'Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP \\< 130/80 mmHg is presented'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, open-label, multi-center study, which will provide detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive patients requiring combination therapy. This will present a convenient treatment option for hypertension in Korean patients.', 'detailedDescription': 'Study Design:\n\nPMS Observational study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Korean patients wtih essential hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nNo specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.\n\nExclusion criteria:\n\nNo specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.'}, 'identificationModule': {'nctId': 'NCT01243268', 'briefTitle': 'A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy', 'orgStudyIdInfo': {'id': '1235.40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with essential hypertension', 'interventionNames': ['Drug: Twynsta tablet']}], 'interventions': [{'name': 'Twynsta tablet', 'type': 'DRUG', 'description': 'Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10', 'armGroupLabels': ['Patients with essential hypertension']}]}, 'contactsLocationsModule': {'locations': [{'city': 'One Or Multiple Sites', 'country': 'South Korea', 'facility': 'NISND Center'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}