Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001452-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron 50 mg | Experimental | Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. |
|
| Mirabegron 100 mg | Experimental | Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months. |
|
| Tolterodine ER 4 mg | Active Comparator | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homewood | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23195283 | Background | Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
Not provided
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/.
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.
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.
After screening, 2792 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 2452 eligible patients were randomly assigned to receive mirabegron 50 mg, or mirabegron 100 mg or tolterodine ER 4 mg once daily for 12 months.
Patients who completed the 12-week treatment and safety follow-up periods of studies 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909), as well as patients that did not participate in these studies were enrolled into this study if they met all inclusion criteria and none of the exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mirabegron 50 mg | Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. |
| FG001 | Mirabegron 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Tolterodine | Drug | Extended release capsules |
|
| Placebo to Mirabegron | Drug | Matching mirabegron placebo tablets. |
|
| Placebo to Tolterodine | Drug | Matching tolterodine placebo capsules. |
|
| Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. | Months 1, 3, 6, 9 and 12 |
| Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Month 12 |
| Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | Baseline and Month 12 |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. | Baseline and Months 3, 6 and 12 |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. | Baseline and Months 3, 6 and 12 |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. | Baseline and Months 3, 6 and 12 |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. | Baseline and Months 3, 6 and 12 |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | Baseline and Month 12 |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | Baseline and Month 12 |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. | Baseline and Month 12 |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | Baseline and Month 12 |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | Baseline and Month 12 |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement. | Baseline and Months 1, 3, 6, 9 and 12 |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition. | Baseline and Months 3, 6 and 12 |
| Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. | Baseline and Month 12 |
| Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event. The data reported represent the number of participants with adverse events in each category. | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Mobile | Alabama | 36608 | United States |
| Montgomery | Alabama | 36117 | United States |
| Anchorage | Alaska | 99508 | United States |
| Phoenix | Arizona | 85051 | United States |
| Tucson | Arizona | 85712 | United States |
| Tucson | Arizona | 85741 | United States |
| Atherton | California | 94027 | United States |
| Beverly Hills | California | 90211 | United States |
| Buena Park | California | 90620 | United States |
| Fresno | California | 93720 | United States |
| La Mesa | California | 91942 | United States |
| Mission Hills | California | 91345 | United States |
| Newport Beach | California | 92660 | United States |
| Orange | California | 92869 | United States |
| Sacramento | California | 95831 | United States |
| San Bernardino | California | 92404 | United States |
| San Diego | California | 92108 | United States |
| San Diego | California | 92120 | United States |
| Tarzana | California | 91356 | United States |
| Torrance | California | 90505 | United States |
| Aurora | Colorado | 80012 | United States |
| Denver | Colorado | 80211 | United States |
| Denver | Colorado | 80218 | United States |
| Englewood | Colorado | 80112 | United States |
| New Britain | Connecticut | 06052 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Aventura | Florida | 33180 | United States |
| Clearwater | Florida | 33756 | United States |
| Clearwater | Florida | 33761 | United States |
| Fort Myers | Florida | 33916 | United States |
| Miami | Florida | 33136 | United States |
| Ocala | Florida | 34471 | United States |
| Orlando | Florida | 32803 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Pembroke Pines | Florida | 33027 | United States |
| Sarasota | Florida | 34237 | United States |
| Tallahassee | Florida | 32308 | United States |
| Tampa | Florida | 33606 | United States |
| Wellington | Florida | 33414 | United States |
| West Palm Beach | Florida | 33407 | United States |
| Atlanta | Georgia | 30328 | United States |
| Decatur | Georgia | 30034 | United States |
| Marietta | Georgia | 30060 | United States |
| Roswell | Georgia | 30076 | United States |
| Coeur d'Alene | Idaho | 83814 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Melrose Park | Illinois | 60160 | United States |
| Fort Wayne | Indiana | 46825 | United States |
| Jeffersonville | Indiana | 47130 | United States |
| Newburgh | Indiana | 47630 | United States |
| Des Moines | Iowa | 50309 | United States |
| Wichita | Kansas | 57207 | United States |
| Greenbelt | Maryland | 20770 | United States |
| Watertown | Massachusetts | 02472 | United States |
| North Kansas City | Missouri | 64116 | United States |
| Billings | Montana | 59102 | United States |
| Lincoln | Nebraska | 68516 | United States |
| Omaha | Nebraska | 68114 | United States |
| Las Vegas | Nevada | 89148 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| West Orange | New Jersey | 07052 | United States |
| Albuquerque | New Mexico | 87109 | United States |
| Albany | New York | 12205 | United States |
| Albany | New York | 12208 | United States |
| Endwell | New York | 13760 | United States |
| Garden City | New York | 11530 | United States |
| Kingston | New York | 12401 | United States |
| New York | New York | 10016 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Cary | North Carolina | 27518 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Concord | North Carolina | 28025 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58104 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Cleveland | Ohio | 44122 | United States |
| Columbus | Ohio | 43214 | United States |
| Lyndhurst | Ohio | 44124 | United States |
| Wadsworth | Ohio | 44281 | United States |
| Bethany | Oklahoma | 73008 | United States |
| Edmond | Oklahoma | 73008 | United States |
| Edmond | Oklahoma | 73034 | United States |
| Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Jenkintown | Pennsylvania | 19046 | United States |
| Lancaster | Pennsylvania | 17604 | United States |
| Reading | Pennsylvania | 19611 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Greer | South Carolina | 29650 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Bristol | Tennessee | 37620 | United States |
| Arlington | Texas | 76017 | United States |
| Austin | Texas | 78759 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77024 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Virginia Beach | Virginia | 23454 | United States |
| Mountlake Terrace | Washington | 98043 | United States |
| Seattle | Washington | 98166 | United States |
| Spokane | Washington | 99204 | United States |
| Tacoma | Washington | 98405 | United States |
| Woolloongabba | Australia |
| Graz | 8036 | Austria |
| Innsbruck | 6020 | Austria |
| Linz | 4020 | Austria |
| Minsk | 220036 | Belarus |
| Minsk | 223041 | Belarus |
| Antwerp | 2020 | Belgium |
| Antwerp | 2030 | Belgium |
| Edegem | 2650 | Belgium |
| Ghent | 9000 | Belgium |
| Kortrijk | 8500 | Belgium |
| Leper | 8900 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Sint-Truiden | 3800 | Belgium |
| Calgary | Alberta | T2V 4R6 | Canada |
| Edmonton | Alberta | T5H 3V9 | Canada |
| Surrey | British Columbia | V3V 1N1 | Canada |
| Victoria | British Columbia | V8T 5G1 | Canada |
| Victoria | British Columbia | V8V 3N1 | Canada |
| Saint John | New Brunswick | E2L 3J8 | Canada |
| Dartmouth | Nova Scotia | B2W 2S7 | Canada |
| Kentville | Nova Scotia | B4N 4K9 | Canada |
| Barrie | Ontario | L4M 7G1 | Canada |
| Brampton | Ontario | L6T 4S5 | Canada |
| Kitchener | Ontario | N2N 2B9 | Canada |
| Markham | Ontario | L6B 1A1 | Canada |
| Newmarket | Ontario | L3X 1W1 | Canada |
| North Bay | Ontario | P1B 7K8 | Canada |
| Oshawa | Ontario | L1H 1B9 | Canada |
| Saint Denis | Ontario | H2X 3J4 | Canada |
| Thunder Bay | Ontario | P7E 6E7 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Granby | Quebec | J2G 8Z9 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Point Claire | Quebec | H9R 4S3 | Canada |
| Montreal | Canada |
| Brno | 60200 | Czechia |
| Mělník | 27601 | Czechia |
| Olomouc | 77200 | Czechia |
| Ostrava-Poruba | 70853 | Czechia |
| Pilsen | 30599 | Czechia |
| Prague | 12851 | Czechia |
| Prague | 14056 | Czechia |
| Prague | 18081 | Czechia |
| Štětí | 41108 | Czechia |
| Ústí nad Labem | 40001 | Czechia |
| Aalborg | 9100 | Denmark |
| Aarhus | 8200 | Denmark |
| Glostrup Municipality | 2600 | Denmark |
| Roskilde | Denmark |
| Helsinki | 00029 | Finland |
| Oulu | 90220 | Finland |
| Tampere | 33521 | Finland |
| Turku | 20100 | Finland |
| Paris | Cedex 10 | 75020 | France |
| Colmar | 68024 | France |
| Marseille | 13274 | France |
| Mulhouse | 68070 | France |
| Nîmes | 30029 | France |
| Orléans | 45067 | France |
| Paris-Cedex12 | 75571 | France |
| Saint-Priest-en-Jarez | 42055 | France |
| Strasbourg | 67000 | France |
| Toulouse | 31059 | France |
| Aichach | 86551 | Germany |
| Bad Ems | 56130 | Germany |
| Bautzen | 02625 | Germany |
| Berlin | 13347 | Germany |
| Duisburg | 47051 | Germany |
| Eisleben Lutherstadt | 06295 | Germany |
| Frankfurt | 65933 | Germany |
| Ganderkesee | 27777 | Germany |
| Hagenow | 19230 | Germany |
| Halle | 06132 | Germany |
| Hamburg | 20253 | Germany |
| Henningsdorf | 16761 | Germany |
| Hettstedt | 06333 | Germany |
| Kiel | Germany |
| Koblenz | 56068 | Germany |
| Leipzig | 04105 | Germany |
| Muenchen-Bogenhausen | 81925 | Germany |
| Munich | Germany |
| Neustadt in Sachsen | 01844 | Germany |
| Oranienburg | 16151 | Germany |
| Radebeul | 01445 | Germany |
| Sangerhausen | 06526 | Germany |
| Trier | 54290 | Germany |
| Uetersen | 25436 | Germany |
| Budapest | 1047 | Hungary |
| Budapest | 1076 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Sopron | Hungary |
| Szeged | 6725 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Tatabánya | 2800 | Hungary |
| Reykjavik | 101 | Iceland |
| Dublin | Ireland |
| Mullingar | Ireland |
| Bari | 70124 | Italy |
| Catanzaro | 88100 | Italy |
| Genoa | 16128 | Italy |
| Latina | 04100 | Italy |
| Milan | 20142 | Italy |
| Modena | 41100 | Italy |
| Naples | 80131 | Italy |
| Perugia | 06122 | Italy |
| Treviglio | 24047 | Italy |
| Varese | 21100 | Italy |
| Liepāja | Latvia |
| Riga | Latvia |
| Kaunas | Lithuania |
| Amsterdam | 1105 AZ | Netherlands |
| Apeldoorn | 7334 DZ | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Enschede | 7511 JX | Netherlands |
| Leiden | 2334 CK | Netherlands |
| Nijmegen | 6532 SZ | Netherlands |
| Sneek | 8600 BA | Netherlands |
| Tilburg | 5022 GC | Netherlands |
| Winterswijk | 7101 BN | Netherlands |
| Bergen | 5021 | Norway |
| Drammen | 3016 | Norway |
| Hamar | 2317 | Norway |
| Oslo | 0257 | Norway |
| Tønsberg | 3103 | Norway |
| Bialystok | 15-278 | Poland |
| Lodz | 93-338 | Poland |
| Lodz | 93-513 | Poland |
| Lublin | 20-954 | Poland |
| Warsaw | 00-846 | Poland |
| Warsaw | 02-005 | Poland |
| Warsaw | 02-507 | Poland |
| Warsaw | Poland |
| Wroclaw | 50-556 | Poland |
| Amadora | 2700 | Portugal |
| Porto | 4099-005 | Portugal |
| Tomar | 2304-909 | Portugal |
| Bucharest | 22328 | Romania |
| Bucharest | Romania |
| Lasi | Romania |
| Oradea | Romania |
| Moscow | 101000 | Russia |
| Moscow | 105425 | Russia |
| Moscow | 111020 | Russia |
| Moscow | 111123 | Russia |
| Moscow | 117049 | Russia |
| Moscow | 117815 | Russia |
| Moscow | 119435 | Russia |
| Moscow | 123836 | Russia |
| Moscow | 125206 | Russia |
| Saint Petersburg | 115516 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 198013 | Russia |
| Martin | 03659 | Slovakia |
| Poprad | 05801 | Slovakia |
| Skalica | 90982 | Slovakia |
| Trenčín | 91101 | Slovakia |
| Žilina | 01207 | Slovakia |
| Hatfield | South Africa |
| Lyttelton | South Africa |
| Paarl | South Africa |
| Pietermaritzburg | South Africa |
| Roodepoort | South Africa |
| Barcelona | 08020 | Spain |
| Barcelona | 08036 | Spain |
| Bilbao | 48013 | Spain |
| Getafe | 28905 | Spain |
| Madrid | 28016 | Spain |
| Madrid | 28046 | Spain |
| Mataró | 8304 | Spain |
| Miranda de Ebro | 09200 | Spain |
| Seville | 41013 | Spain |
| Toledo | 45071 | Spain |
| Valencia | 46010 | Spain |
| Huddinge | 75185 | Sweden |
| Örebro | 70185 | Sweden |
| Skövde | 54130 | Sweden |
| Sonkoping | 11883 | Sweden |
| Stockholm | 14186 | Sweden |
| Stockholm | 17176 | Sweden |
| Stockholm | 18288 | Sweden |
| Umeå | 90185 | Sweden |
| Frauenfeld | 8501 | Switzerland |
| Lucerne | 6000 | Switzerland |
| Kiev | 01023 | Ukraine |
| Kiev | 04053 | Ukraine |
| Bristol | B15 2TG | United Kingdom |
| Chorley | PR7 7NA | United Kingdom |
| Croydon | CR7 7YE | United Kingdom |
| Liverpool | L22 OLG | United Kingdom |
| London | SE5 9RS | United Kingdom |
| London | W2 2YP | United Kingdom |
| Manchester | M15 6SX | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Northwood | HA6 2RN | United Kingdom |
| Reading | RG1 5AN | United Kingdom |
| Reading | RG2 7AG | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| Swansea | SA6 6NL | United Kingdom |
Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
| FG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
| Safety Analysis Set (SAF) |
|
| Full Analysis Set (FAS) |
|
| Full Analysis Set Incontinence (FAS-I) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mirabegron 50 mg | Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. |
| BG001 | Mirabegron 100 mg | Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months. |
| BG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline Measure data are provided for all randomized patients who took at least 1 dose of double-blind study drug (Safety Analysis Set). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Type of overactive bladder (OAB) | Number | participants |
| ||||||||||||||||
| Duration of OAB symptoms | Mean | Standard Deviation | months |
| |||||||||||||||
| Summary of previous treatment | Number | participants |
| ||||||||||||||||
| Mean number of micturitions per 24 Hours | The average number of micturitions (urinations) per 24 hours recorded by the patient in a micturition diary for 3 days prior to the Baseline visit. | Mean | Standard Deviation | micturitions |
| ||||||||||||||
| Mean volume voided per micturition | Recorded by the patient in a micturition diary for 3 days prior to the Baseline visit. | Mean | Standard Deviation | mL |
| ||||||||||||||
| Mean number of urgency episodes (grade 3 or 4) per 24 hours | Urgency episodes were those classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency (PPIUS) scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. | Mean | Standard Deviation | urgency episodes |
| ||||||||||||||
| Mean level of urgency | Average of patients' ratings on the degree of associated urgency for each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Mean number of nocturia episodes per 24 hours | The average number of times a patient woke at night to urinate (excluding incontinence only episodes) recorded for 3 days prior to the Baseline visit in the patient micturition diary. | Mean | Standard Deviation | nocturia episodes |
| ||||||||||||||
| Mean number of pads used per 24 hours | Recorded by the patient in a micturition diary for 3 days prior to the Baseline visit. | Mean | Standard Deviation | pads |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. | The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug. | Posted | Number | participants | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis. | Posted | Least Squares Mean | Standard Error | micturitions | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis. | Posted | Least Squares Mean | Standard Error | incontinence episodes | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis. | Posted | Least Squares Mean | Standard Error | mL | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | urgency incontinence episodes | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | urgency episodes | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit | Posted | Least Squares Mean | Standard Error | pads | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | nocturia episodes | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis. | Posted | Number | percentage of participants | Months 1, 3, 6, 9 and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis. | Posted | Number | percentage of participants | Baseline and Months 1, 3, 6, 9 and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Month 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Month 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis. | Posted | Mean | Standard Deviation | Percent work time missed | Baseline and Months 3, 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis. | Posted | Mean | Standard Deviation | Percent impairment while working | Baseline and Months 3, 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis. | Posted | Mean | Standard Deviation | Percent overall work impairment | Baseline and Months 3, 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline value. LOCF was used for the Final Visit analysis. | Posted | Mean | Standard Deviation | Percent activity impairment | Baseline and Months 3, 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | Posted | Number | participants | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | Posted | Number | participants | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | Posted | Number | participants | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | Posted | Number | participants | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | Posted | Number | participants | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis. | Posted | Mean | Standard Deviation | Physician visits | Baseline and Months 3, 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. | The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis. | Posted | Number | percentage of participants | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event. The data reported represent the number of participants with adverse events in each category. | The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug. | Posted | Number | participants | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. |
|
Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirabegron 50 mg | Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. | 42 | 812 | 136 | 812 | ||
| EG001 | Mirabegron 100 mg | Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months. | 51 | 820 | 137 | 820 | ||
| EG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. | 44 | 812 | 181 | 812 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Endometrial cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Cardiac pacemaker malfunction | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Cystocele repair | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Gastrectomy | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Gastric bypass | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Spinal fusion surgery | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Uterine prolapse repair | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Cystopexy | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Foot operation | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Spinal laminectomy | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Thyroidectomy | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Intestinal gangrene | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cerebral circulatory failure | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Global amnesia | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Arthroscopy | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Open angle glaucoma | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Global Medical Sciences | Astellas Pharma Global Development, Inc. | ClinicalTrials.Disclosure@us.astellas.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
Not provided
Not provided
| Male |
|
| Mixed |
|
| Frequency |
|
| Mirabegron 50 mg |
|
| Mirabegron 100 mg |
|
| Tolterodine ER 4 mg |
|
| Naive |
|
|
| Severe adverse events |
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
|
|
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. |
|
|