Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 3:59 PM
Study NCT ID:
NCT01043666
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2010-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of YM178 in Subjects With Symptoms of Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2011-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean number of micturitions per 24 hrs', 'timeFrame': 'Within a 12-week treatment period'}], 'secondaryOutcomes': [{'measure': 'Change in mean number of urgency episodes per 24 hrs', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change in mean number of urinary incontinence episodes per 24 hrs', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change in mean number of urge incontinence episodes per 24 hrs', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change in mean volume voided per micturition', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change in mean number of nocturia episodes', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume', 'timeFrame': 'During 12-week treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Micturition', 'YM178', 'Urinary incontinence', 'Frequency', 'Overactive Bladder', 'Urgency', 'Urinary urge incontinence'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '37160401', 'type': 'DERIVED', 'citation': 'Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=168', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with symptoms of overactive bladder for at least 12 weeks before the study\n* Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself\n* Subject with an average frequency of micturition of 8 or more times per 24-hour period\n* Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period\n* Subject having provided written informed consent by him/herself\n\nExclusion Criteria:\n\n* Subject having stress urinary incontinence as a predominant symptom\n* Subject with transient symptoms suspected for overactive bladder\n* Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection\n* Subject complicated with bladder tumor/prostatic tumor or with the historical condition\n* Subject confirmed to have a post-void residual volume of \\>=100ml or with a clinically significant lower urinary tract obstructive disease\n* Subject with indwelling catheter or practicing intermittent self-catheterization\n* Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia\n* Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study\n* Subject with uncontrolled hypertension (indicated by sitting SBP \\>=180mmHg or DPB \\>= 110mmHg)\n* Subject with a pulse rate \\>= 110bpm or \\<50 bpm'}, 'identificationModule': {'nctId': 'NCT01043666', 'briefTitle': 'A Study of YM178 in Subjects With Symptoms of Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder', 'orgStudyIdInfo': {'id': '178-CL-090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YM178 group', 'description': 'oral', 'interventionNames': ['Drug: YM178']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'oral', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'tolterodine ER group', 'description': 'oral', 'interventionNames': ['Drug: tolterodine ER']}], 'interventions': [{'name': 'YM178', 'type': 'DRUG', 'otherNames': ['mirabegron'], 'description': 'oral', 'armGroupLabels': ['YM178 group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['placebo group']}, {'name': 'tolterodine ER', 'type': 'DRUG', 'otherNames': ['Detrusitol SR'], 'description': 'oral', 'armGroupLabels': ['tolterodine ER group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Dalian', 'country': 'China', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Fuzhou', 'country': 'China', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hubei', 'country': 'China', 'geoPoint': {'lat': 38.99842, 'lon': 112.01144}}, {'city': 'Hunan', 'country': 'China', 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'city': 'Jiangsu', 'country': 'China'}, {'city': 'Liaoning', 'country': 'China'}, {'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Ahmedabad', 'country': 'India', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Gurgaon', 'country': 'India', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Jaipur', 'country': 'India', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Lucknow', 'country': 'India', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'New Delhi', 'country': 'India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Pune', 'country': 'India', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Chungcheong Namdo', 'country': 'South Korea'}, {'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Incheon', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeollabuk', 'country': 'South Korea'}, {'city': 'Jeollanam', 'country': 'South Korea'}, {'city': 'Kyonggi', 'country': 'South Korea'}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Chiayi City', 'country': 'Taiwan', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'city': 'Hualien City', 'country': 'Taiwan', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}