Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT00561951
Status:
COMPLETED
Last Update Posted:
2011-07-14
First Post:
2007-11-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Sponsor:
Organization:
Raw JSON
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Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.', 'otherNumAtRisk': 318, 'otherNumAffected': 68, 'seriousNumAtRisk': 318, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.', 'otherNumAtRisk': 320, 'otherNumAffected': 138, 'seriousNumAtRisk': 320, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.', 'otherNumAtRisk': 313, 'otherNumAffected': 185, 'seriousNumAtRisk': 313, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 158}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Residual urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'groupId': 'OG000', 'lowerLimit': '-1.31', 'upperLimit': '-0.71'}, {'value': '-1.35', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '-1.05'}, {'value': '-1.40', 'groupId': 'OG002', 'lowerLimit': '-1.70', 'upperLimit': '-1.09'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.13', 'pValueComment': 'The closed testing procedure was used in order to control the probability of a type 1 error.', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.17', 'pValueComment': 'The closed testing procedure was used in order to control the probability of a type 1 error.', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'UUI Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=308, 314, 305)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '1.465', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '1.681', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '1.736', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=301, 303, 296)', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.532', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '1.688', 'groupId': 'OG001'}, {'value': '-1.49', 'spread': '1.643', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=289, 289, 287)', 'categories': [{'measurements': [{'value': '-1.45', 'spread': '1.518', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '1.680', 'groupId': 'OG001'}, {'value': '-1.65', 'spread': '1.690', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=284, 284, 281)', 'categories': [{'measurements': [{'value': '-1.49', 'spread': '1.717', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '1.618', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '1.814', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at each visit minus mean at Baseline.', 'unitOfMeasure': 'UUI Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000', 'lowerLimit': '-1.08', 'upperLimit': '-0.10'}, {'value': '-1.15', 'groupId': 'OG001', 'lowerLimit': '-1.64', 'upperLimit': '-0.67'}, {'value': '-1.25', 'groupId': 'OG002', 'lowerLimit': '-1.75', 'upperLimit': '-0.76'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.22', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.32', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'Micturitions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=308, 314, 305)', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.786', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.987', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '2.076', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=301, 303, 296)', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '1.960', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '2.146', 'groupId': 'OG001'}, {'value': '-1.60', 'spread': '2.246', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=289, 289, 287)', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '2.215', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '2.277', 'groupId': 'OG001'}, {'value': '-2.15', 'spread': '2.402', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=284, 284, 281)', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '2.415', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '2.214', 'groupId': 'OG001'}, {'value': '-2.17', 'spread': '2.515', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at each visit minus mean at Baseline.', 'unitOfMeasure': 'Micturitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-0.40'}, {'value': '-1.65', 'groupId': 'OG001', 'lowerLimit': '-2.25', 'upperLimit': '-1.05'}, {'value': '-1.66', 'groupId': 'OG002', 'lowerLimit': '-2.27', 'upperLimit': '-1.05'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.22', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.23', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'Urgency Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=308, 314, 305)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '2.640', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '2.722', 'groupId': 'OG001'}, {'value': '-1.59', 'spread': '2.816', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=301, 303, 296)', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '2.780', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '2.906', 'groupId': 'OG001'}, {'value': '-2.16', 'spread': '3.065', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=289, 289, 287)', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '2.835', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '3.080', 'groupId': 'OG001'}, {'value': '-2.71', 'spread': '3.139', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=284, 284, 281)', 'categories': [{'measurements': [{'value': '-2.37', 'spread': '2.975', 'groupId': 'OG000'}, {'value': '-2.89', 'spread': '2.838', 'groupId': 'OG001'}, {'value': '-3.05', 'spread': '3.462', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at each visit minus mean at Baseline.', 'unitOfMeasure': 'Urgency Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.88', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '-0.54'}, {'value': '-1.27', 'groupId': 'OG001', 'lowerLimit': '-1.61', 'upperLimit': '-0.93'}, {'value': '-1.15', 'groupId': 'OG002', 'lowerLimit': '-1.50', 'upperLimit': '-0.80'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.14', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '-0.03', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nIncontinence is the complaint of any involuntary leakage of urine.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'Incontinence Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=308, 314, 305)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.573', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '1.725', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '1.887', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=301, 303, 296)', 'categories': [{'measurements': [{'value': '-1.22', 'spread': '1.598', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '1.755', 'groupId': 'OG001'}, {'value': '-1.50', 'spread': '1.707', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=289, 289, 287)', 'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.727', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '1.795', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '1.760', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=284, 284, 281)', 'categories': [{'measurements': [{'value': '-1.59', 'spread': '1.869', 'groupId': 'OG000'}, {'value': '-1.97', 'spread': '1.843', 'groupId': 'OG001'}, {'value': '-1.86', 'spread': '2.000', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nIncontinence is the complaint of any involuntary leakage of urine.\n\nChange: mean at each visit minus mean at Baseline.', 'unitOfMeasure': 'Incontinence Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.41', 'upperLimit': '0.06'}, {'value': '-0.21', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '0.02'}, {'value': '-0.29', 'groupId': 'OG002', 'lowerLimit': '-0.52', 'upperLimit': '-0.05'}]}]}], 'analyses': [{'pValue': '0.624', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.11', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.03', 'groupDescription': 'The significance level was 0.05 (2-sided).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'Night-Time Micturitions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .\n\nLast observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=242, 256, 256)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.696', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.796', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.809', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=236, 246, 248)', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.835', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.830', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.780', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=224, 232, 241)', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.820', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.815', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.903', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=220, 229, 236)', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.945', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.882', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '0.945', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at each visit minus mean at Baseline.', 'unitOfMeasure': 'Night-Time Micturitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.\n\nNo imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Voided Volume Per Micturition at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.07', 'spread': '46.207', 'groupId': 'OG000'}, {'value': '22.80', 'spread': '47.590', 'groupId': 'OG001'}, {'value': '32.77', 'spread': '52.893', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nVoided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=308, 314, 304)', 'categories': [{'measurements': [{'value': '5.06', 'spread': '37.875', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '35.350', 'groupId': 'OG001'}, {'value': '21.52', 'spread': '42.946', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=301, 303, 296)', 'categories': [{'measurements': [{'value': '9.23', 'spread': '43.639', 'groupId': 'OG000'}, {'value': '21.62', 'spread': '44.623', 'groupId': 'OG001'}, {'value': '27.41', 'spread': '45.803', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=289, 289, 287)', 'categories': [{'measurements': [{'value': '10.75', 'spread': '45.628', 'groupId': 'OG000'}, {'value': '22.05', 'spread': '44.949', 'groupId': 'OG001'}, {'value': '30.94', 'spread': '51.258', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=284, 284, 281)', 'categories': [{'measurements': [{'value': '13.28', 'spread': '46.317', 'groupId': 'OG000'}, {'value': '24.52', 'spread': '48.620', 'groupId': 'OG001'}, {'value': '33.40', 'spread': '53.379', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at each visit minus mean at Baseline.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'General Health Perceptions (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-7.02', 'spread': '22.573', 'groupId': 'OG000'}, {'value': '-9.36', 'spread': '25.190', 'groupId': 'OG001'}, {'value': '-6.10', 'spread': '25.272', 'groupId': 'OG002'}]}]}, {'title': 'Impact on Life (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-22.46', 'spread': '28.018', 'groupId': 'OG000'}, {'value': '-27.33', 'spread': '29.960', 'groupId': 'OG001'}, {'value': '-25.09', 'spread': '32.172', 'groupId': 'OG002'}]}]}, {'title': 'Role Limitations (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-20.47', 'spread': '27.730', 'groupId': 'OG000'}, {'value': '-27.92', 'spread': '26.373', 'groupId': 'OG001'}, {'value': '-25.97', 'spread': '28.590', 'groupId': 'OG002'}]}]}, {'title': 'Physical Limitations (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-18.65', 'spread': '28.250', 'groupId': 'OG000'}, {'value': '-23.50', 'spread': '28.807', 'groupId': 'OG001'}, {'value': '-25.97', 'spread': '28.278', 'groupId': 'OG002'}]}]}, {'title': 'Social Limitations (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-14.44', 'spread': '25.541', 'groupId': 'OG000'}, {'value': '-17.92', 'spread': '24.029', 'groupId': 'OG001'}, {'value': '-18.53', 'spread': '25.765', 'groupId': 'OG002'}]}]}, {'title': 'Personal Relationships (n=214, 210, 202)', 'categories': [{'measurements': [{'value': '-8.33', 'spread': '21.773', 'groupId': 'OG000'}, {'value': '-16.11', 'spread': '25.798', 'groupId': 'OG001'}, {'value': '-9.98', 'spread': '24.335', 'groupId': 'OG002'}]}]}, {'title': 'Emotions (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-18.01', 'spread': '26.365', 'groupId': 'OG000'}, {'value': '-24.70', 'spread': '27.192', 'groupId': 'OG001'}, {'value': '-24.89', 'spread': '27.310', 'groupId': 'OG002'}]}]}, {'title': 'Sleep/Energy (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-12.51', 'spread': '24.967', 'groupId': 'OG000'}, {'value': '-19.08', 'spread': '23.800', 'groupId': 'OG001'}, {'value': '-18.02', 'spread': '25.287', 'groupId': 'OG002'}]}]}, {'title': 'Incontinence Severity Measures (n=285, 283, 283)', 'categories': [{'measurements': [{'value': '-13.75', 'spread': '20.763', 'groupId': 'OG000'}, {'value': '-17.67', 'spread': '21.038', 'groupId': 'OG001'}, {'value': '-18.59', 'spread': '21.814', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week12', 'description': "King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.\n\nChange: mean at Week 12 minus mean at Baseline.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Symptom Bother Score', 'categories': [{'measurements': [{'value': '-18.25', 'spread': '23.618', 'groupId': 'OG000'}, {'value': '-26.61', 'spread': '22.592', 'groupId': 'OG001'}, {'value': '-26.35', 'spread': '23.849', 'groupId': 'OG002'}]}]}, {'title': 'Total Score of HRQL domain', 'categories': [{'measurements': [{'value': '12.88', 'spread': '18.868', 'groupId': 'OG000'}, {'value': '17.84', 'spread': '17.880', 'groupId': 'OG001'}, {'value': '17.29', 'spread': '19.670', 'groupId': 'OG002'}]}]}, {'title': 'Coping Score of HRQL domain', 'categories': [{'measurements': [{'value': '16.54', 'spread': '23.633', 'groupId': 'OG000'}, {'value': '21.01', 'spread': '22.109', 'groupId': 'OG001'}, {'value': '21.48', 'spread': '25.336', 'groupId': 'OG002'}]}]}, {'title': 'Concern Score of HRQL domain', 'categories': [{'measurements': [{'value': '13.25', 'spread': '21.182', 'groupId': 'OG000'}, {'value': '20.05', 'spread': '20.526', 'groupId': 'OG001'}, {'value': '19.10', 'spread': '21.868', 'groupId': 'OG002'}]}]}, {'title': 'Sleep Score of HRQL domain', 'categories': [{'measurements': [{'value': '12.03', 'spread': '22.215', 'groupId': 'OG000'}, {'value': '16.16', 'spread': '21.886', 'groupId': 'OG001'}, {'value': '15.35', 'spread': '24.654', 'groupId': 'OG002'}]}]}, {'title': 'Social Score of HRQL domain', 'categories': [{'measurements': [{'value': '7.37', 'spread': '17.211', 'groupId': 'OG000'}, {'value': '11.35', 'spread': '16.504', 'groupId': 'OG001'}, {'value': '9.98', 'spread': '16.706', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).\n\nThe each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.57', 'spread': '1.236', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '1.157', 'groupId': 'OG001'}, {'value': '-1.76', 'spread': '1.182', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:\n\n1. No problems at all\n2. Some very minor problems\n3. Some minor problems\n4. Some moderate problems\n5. Severe problems\n6. Many severe problems\n\nChange: mean at Week 12 minus mean at Baseline.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:\n\n1. No problems at all\n2. Some very minor problems\n3. Some minor problems\n4. Some moderate problems\n5. Severe problems\n6. Many severe problems', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. No imputation was used for missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'FG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '318'}, {'groupId': 'FG001', 'numSubjects': '320'}, {'groupId': 'FG002', 'numSubjects': '313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}, {'groupId': 'FG001', 'numSubjects': '286'}, {'groupId': 'FG002', 'numSubjects': '281'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Meet Withdrawal Criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event Occured Before Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}, {'value': '951', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects were treated with placebo once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Fesoterodine 4 mg', 'description': 'Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.'}, {'id': 'BG002', 'title': 'Fesoterodine 8 mg', 'description': 'Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '640', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '13.4', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '13.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}, {'value': '757', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 951}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2007-11-19', 'resultsFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-18', 'studyFirstPostDateStruct': {'date': '2007-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at Week 12 minus mean at Baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at each visit minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at each visit minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nUrgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.\n\nChange: mean at each visit minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nIncontinence is the complaint of any involuntary leakage of urine.\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nIncontinence is the complaint of any involuntary leakage of urine.\n\nChange: mean at each visit minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at each visit minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Voided Volume Per Micturition at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nVoided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.\n\nChange: mean at each visit minus mean at Baseline.'}, {'measure': "Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).", 'timeFrame': 'Baseline to Week12', 'description': "King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.\n\nChange: mean at Week 12 minus mean at Baseline."}, {'measure': 'Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).\n\nThe each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:\n\n1. No problems at all\n2. Some very minor problems\n3. Some minor problems\n4. Some moderate problems\n5. Severe problems\n6. Many severe problems\n\nChange: mean at Week 12 minus mean at Baseline.'}, {'measure': 'The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.', 'timeFrame': 'Baseline to Week 12', 'description': 'Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:\n\n1. No problems at all\n2. Some very minor problems\n3. Some minor problems\n4. Some moderate problems\n5. Severe problems\n6. Many severe problems'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221005&StudyName=Dose-Finding%20Study%20To%20Evaluate%20The%20Efficacy%2C%20Tolerability%20And%20Safety%20Of%20Fesoterodine%20In%20Comparison%20To%20Placebo%20For%20Overactive%20Bladder.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult OAB patients who present with OAB symptoms, including micturitions \\>= 8 per day and urgency urinary incontinence \\>= 1 per day.\n\nExclusion Criteria:\n\n* Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.\n* Patient has a known neurological disease influencing bladder function.\n* Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.'}, 'identificationModule': {'nctId': 'NCT00561951', 'briefTitle': 'Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.', 'orgStudyIdInfo': {'id': 'A0221005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fesoterodine fumarate 4 mg (Double-Blind)', 'interventionNames': ['Drug: fesoterodine fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Double-Blind)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fesoterodine fumarate 8 mg (Double-Blind)', 'interventionNames': ['Drug: fesoterodine fumarate']}], 'interventions': [{'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': '8mg tablets OD for 12 weeks', 'armGroupLabels': ['Fesoterodine fumarate 8 mg (Double-Blind)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Corresponding placebo tablets OD for 12 weeks', 'armGroupLabels': ['Placebo (Double-Blind)']}, {'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': '4mg tablets OD for 12 weeks', 'armGroupLabels': ['Fesoterodine fumarate 4 mg (Double-Blind)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}, {'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Chuo-ku, Chiba-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Eiheiji-cyo,yoshida-gun,', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Koga-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Minami-ku, Fukuoka-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer 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