Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02570035
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in electrocardiogram parameters pre- and post- administration of mirabegron', 'timeFrame': 'Baseline and up to four weeks'}, {'measure': 'Incidence rate of cardiovascular system adverse reactions', 'timeFrame': 'Up to four weeks'}, {'measure': 'Safety assessed by biochemistry laboratory tests', 'timeFrame': 'Up to four weeks'}, {'measure': 'Safety assessed by incidence of adverse events', 'timeFrame': 'Up to four weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in overactive bladder (OAB) symptoms', 'timeFrame': 'Baseline and up to four weeks', 'description': 'Clinical global impression of change from baseline of OAB symptoms by investigator'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mirabegron', 'Overactive Bladder', 'Cardiovascular Disease'], 'conditions': ['Overactive Bladder', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having coexisting cardiovascular disease or a history of cardiovascular diseases\n* having electrocardiogram record conducted within seven days before the start of the mirabegron treatment (including the first day of administration)\n\nExclusion Criteria:\n\n* having serious cardiovascular disease\n* having significant long QT (QTc \\> 500 msec)'}, 'identificationModule': {'nctId': 'NCT02570035', 'briefTitle': 'Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)', 'orgStudyIdInfo': {'id': 'BE0003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mirabegron group', 'description': 'Subjects with overactive bladder and cardiovascular disease prescribed mirabegron', 'interventionNames': ['Drug: Mirabegron']}], 'interventions': [{'name': 'Mirabegron', 'type': 'DRUG', 'otherNames': ['YM178', 'Betanis'], 'description': 'oral', 'armGroupLabels': ['Mirabegron group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Site JP81013', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site JP81014', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site JP81005', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site JP81006', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site JP81007', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site JP81026', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site JP81027', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site JP81001'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site JP81002'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP81021', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP81022', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP81023', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP81024', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP81025', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Site JP81028', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP81011', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP81012', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Site JP81003', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81016', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81017', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81018', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81019', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81020', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site JP81004', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site JP81015', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP81008', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP81009', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP81010', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}