| Primary | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable. | The analysis population consisted of the FAS. LOCF was used for EoT. | Posted | | Least Squares Mean | Standard Error | incontinence episodes | | Baseline and end of treatment (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg | Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.8± 0.08
- OG001-1.53± 0.08
- OG002-1.67± 0.08
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate. | stratified rank ANCOVA | | =0.001 | P values for pairwise comparisons were from the stratified rank ANCOVA model. P < 0.05 indicated superiority in favor of treatment group with the largest improvement. | Least Squares (LS) Means | -0.26 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.47 | -0.05 | | | |
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| Secondary | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. | The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | incontinence episodes | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours | The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | micturitions | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Number of Incontinence Episodes Reported During the 3-Day Diary | The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Mean | Standard Error | incontinence episodes | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg |
|
| Secondary | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | mL | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT. | LOCF was used. The analysis population consisted of the FAS. | Posted | | Least Squares Mean | Standard Error | micturitions | | Baseline and EoT (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | |
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| Secondary | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included. | Posted | | Least Squares Mean | Standard Error | UI episodes | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. |
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| Secondary | Number of UI Episodes Reported During the 3-Day Diary | Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included. | Posted | | Mean | Standard Error | UI episodes | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | |
|
| Secondary | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included. | Posted | | Least Squares Mean | Standard Error | urgency episodes | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in Mean Number of Pads Per 24 Hours | The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included. | Posted | | Least Squares Mean | Standard Error | pads | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Number of Pads Used During the 3-Day Diary | The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants who reported use of at least one pad in baseline diary were included. | Posted | | Mean | Standard Error | pads | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Change From Baseline in Mean Number of Nocturia Episodes | Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included. | Posted | | Least Squares Mean | Standard Error | nocturia episodes | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | |
|
| Secondary | Number of Nocturia Episodes Reported Over 3-Day Diary | The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included. | Posted | | Mean | Standard Error | nocturia episodes | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. | LOCF was used for EoT. The analysis population consisted of the FAS. | Posted | | Number | | participants | | Baseline and EoT (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. | LOCF was used for EoT. The analysis population consisted of the FAS. | Posted | | Number | | participants | | Baseline and EoT (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. | LOCF was used for EoT. The analysis population consisted of the FAS. | Posted | | Number | | participants | | Baseline and EoT (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. | LOCF was used for EoT. The analysis population consisted of the FAS. | Posted | | Number | | participants | | Baseline and EoT (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. | LOCF was used for EoT. The analysis population consisted of the FAS. | Posted | | Number | | participants | | Baseline and EoT (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
|
| Secondary | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in OAB-q HRQL Subscale Score: Coping | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in OAB-q HRQL Subscale Score: Concern | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg |
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| Secondary | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)). | LOCF was used for EoT. The analysis population consisted of the FAS. | Posted | | Number | | participants | | End of treatment (up to 12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Incontinence was defined as any involuntary leakage of urine. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg | |
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| Secondary | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Incontinence was defined as any involuntary leakage of urine. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg | Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period. |
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| Secondary | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Micturitions were defined as voluntary urinations (excluding incontinence only episodes). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg |
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| Secondary | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg |
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| Secondary | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg |
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| Secondary | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | Posted | | Number | | percentage of participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg |
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| Secondary | Number of Participants With Adverse Events (AEs) | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake. | The analysis population consisted of the Safety Analysis Set, the SAF comprised all randomized participants who received at least 1 dose of double-blind treatment. | Posted | | Count of Participants | | Participants | | From first dose of double blind treatment until 30 days after last dose (up to 16 weeks) | | | | ID | Title | Description |
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| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period |
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| Secondary | Change From Baseline in Post Void Residual (PVR) Volume | PVR Volume was assessed by bladder scan. | The analysis population consisted of the SAF with data available at each time point. | Posted | | Mean | Standard Deviation | mL | | Baseline and weeks 4, 8 & 12 | | | | ID | Title | Description |
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| OG000 | Combination (Solifenacin + Mirabegron) | Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | | OG001 | Solifenacin 5 mg | Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | | OG002 | Solifenacin 10 mg | Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period. |
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