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The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.
This was a multicenter, open-label study to evaluate the safety and efficacy of add-on therapy with antimuscarinics in patients with OAB treated with mirabegron.
The total duration of the study period was 54 weeks in total, comprising a 2-week screening period and a 52-week treatment period. Patients who met the eligibility criteria for provisional enrollment received orally the study drug for the screening period (mirabegron 50 mg) once daily after breakfast for 2 weeks. Patients who met the eligibility criteria after the screening period were randomized to solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg or tolterodine 4 mg in a 1:1:1:1 ratio, and received orally mirabegron 50 mg and antimuscarinics for 52 weeks. At week 8 visit, the dose of all antimuscarinics except for tolterodine could be increased by 2-fold (solifenacin 10 mg, propiverine 40 mg or imidafenacin 0.4 mg) if a patient met the following criteria: (1) had no response to the study drugs; (2) was considered by the investigator to have no safety concerns; and (3) agreed to increase the dose. However, in the event of AEs after the dose was increased, it could be reduced to the level before the increase. A dose increase for a second time after dose reduction was not permitted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron + Solifenacin | Experimental | Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. |
|
| Mirabegron + Propiverine | Experimental | Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. |
|
| Mirabegron + Imidafenacin | Experimental | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
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| Mirabegron + Tolterodine | Experimental | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron tablet | Drug | orally administered at a dose of 1 tablet once daily after breakfast |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. | From first dose of study drug up to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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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.
Prior to randomization, participants received 50 mg mirabegron orally once daily after breakfast for 2 weeks during a screening period.
Participants with overactive bladder (OAB) were enrolled in 60 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirabegron + Solifenacin | Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Solifenacin tablet | Drug | orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets) |
|
| Propiverine tablet | Drug | orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner) |
|
| Imidafenacin tablet | Drug | orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner) |
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| Tolterodine capsule | Drug | orally administered at a dose of 1 capsule once daily after breakfast (could not be increased) |
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| Baseline and week 4, 8, 12, 16, 28 and 52 |
| Number of Participants Who Achieved Normalization for OABSS Total Score | Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. | Week 52 (end of treatment) |
| Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Symptom Severity and the Health-related Quality of Life (HRQL). The Symptom Severity section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. | Baseline and week 12, 28 and 52 |
| Change From Baseline in OAB-q SF Total HRQL Score | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. | Baseline and week 12, 28 and 52 |
| Change From Baseline in the Mean Number of Micturitions Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded. | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours | Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. | Week 52 (end of treatment) |
| Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis. | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours | Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. | Week 52 (end of treatment) |
| Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis. | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours | Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. | Week 52 (end of treatment) |
| Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis. | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| Change From Baseline in the Mean Volume Voided Per Micturition | Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis. | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| Change From Baseline in the Mean Number of Nocturia Episodes Per Night | Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis. | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours | Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours. | Week 52 (end of treatment) |
| Change From Baseline in Postvoid Residual (PVR) Volume | Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. | Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 |
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyushu | Japan |
| Tōhoku | Japan |
| Mirabegron + Propiverine |
Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. |
| FG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| FG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirabegron + Solifenacin | Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. |
| BG001 | Mirabegron + Propiverine | Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. |
| BG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| BG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
| BG004 | 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 | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Overactive Bladder Symptom Score (OABSS) | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. | Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drugs for the treatment period and who provided evaluable efficacy data for at least 1 variable before and after the start of the treatment period. Participants with available data are included in the analysis. | Mean | Standard Deviation | Units on a Scale |
| ||||||||
| Overactive Bladder questionnaire Short Form (OAB-q SF) Score: Symptom Severity | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | Units on a Scale |
| ||||||||
| OAB-q SF Score: Total Health-Related Quality of Life (HRQOL) | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | Units on a Scale |
| ||||||||
| Mean Number of Micturitions per 24 Hours | The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | micturitions |
| ||||||||
| Mean Number of Urgency Episodes per 24 Hours | An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | urgency episodes |
| ||||||||
| Mean Number of Incontinence Episodes per 24 Hours | An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | incontinence episodes |
| ||||||||
| Mean Number of Urge Incontinence Episodes per 24 Hours | An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | urge incontinence episodes |
| ||||||||
| Mean Volume Voided per Micturition | The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | mL |
| ||||||||
| Mean Number of Nocturia Episodes per Night | A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis. | FAS participants with available data are included in the analysis. | Mean | Standard Deviation | nocturia episodes |
| ||||||||
| Postvoid Residual (PVR) Volume | Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. | Mean | Standard Deviation | mL |
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| 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 Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. | SAF | Posted | Count of Participants | Participants | From first dose of study drug up to week 52 |
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| Secondary | Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 4, 8, 12, 16, 28 and 52 |
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| Secondary | Number of Participants Who Achieved Normalization for OABSS Total Score | Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Count of Participants | Participants | Week 52 (end of treatment) |
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| Secondary | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Symptom Severity and the Health-related Quality of Life (HRQL). The Symptom Severity section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 12, 28 and 52 |
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| Secondary | Change From Baseline in OAB-q SF Total HRQL Score | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 12, 28 and 52 |
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| Secondary | Change From Baseline in the Mean Number of Micturitions Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | micturitions | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
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| Secondary | Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours | Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Count of Participants | Participants | Week 52 (end of treatment) |
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| Secondary | Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis. | FAS participants with available data at each time point are included in the analysis.A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | urgency episodes | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
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| Secondary | Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours | Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Count of Participants | Participants | Week 52 (end of treatment) |
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| Secondary | Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis | Posted | Mean | Standard Deviation | incontinence episodes | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
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| Secondary | Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours | Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Count of Participants | Participants | Week 52 (end of treatment) |
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| Secondary | Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | urge incontinence episodes | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
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| Secondary | Change From Baseline in the Mean Volume Voided Per Micturition | Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | mL | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
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| Secondary | Change From Baseline in the Mean Number of Nocturia Episodes Per Night | Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Mean | Standard Deviation | nocturia episodes | Baseline and week 4, 8, 12, 16, 28, 40, 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours | Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours. | FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis. | Posted | Count of Participants | Participants | Week 52 (end of treatment) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Postvoid Residual (PVR) Volume | Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. | SAF | Posted | Mean | Standard Deviation | mL | Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 |
|
From first dose of study drug up to week 52
Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
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 + Solifenacin | Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. | 0 | 166 | 10 | 166 | 115 | 166 |
| EG001 | Mirabegron + Propiverine | Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. | 0 | 161 | 4 | 161 | 117 | 161 |
| EG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. | 0 | 161 | 5 | 161 | 108 | 161 |
| EG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. | 1 | 159 | 9 | 159 | 97 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Disuse syndrome | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Microscopic polyangiitis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Residual urine volume increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
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 prior to publication for review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Astellas Pharma Inc. | +81-3-3244-0512 | astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000069464 | Solifenacin Succinate |
| C015586 | propiverine |
| C120953 | imidafenacin |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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
|
|
|
|
|
|
|
|
|
|
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Drug-related TEAEs |
|
| TEAEs leading to death |
|
| Drug-related TEAEs leading to death |
|
| Serious TEAEs |
|
| Drug-related serious TEAEs |
|
| TEAEs leading to withdrawal of treatment |
|
| Drug-related TEAEs leading to withdrawal of treat. |
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective.
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective.
| OG002 | Mirabegron + Imidafenacin | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
|
| OG003 | Mirabegron + Tolterodine | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
|
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