| Primary | Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12 | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | number of episodes | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-3.2± 0.2
- OG001-2.9± 0.2
|
|
| | 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 |
|---|
| The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate. | ANCOVA | | 0.1959 | P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons. | Mean Difference (Net) | -0.4 | Standard Error of the Mean | 0.3 | | 95 | -0.9 | 0.2 | | | |
|
| Secondary | Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis. | Posted | | Least Squares Mean | Standard Error | number of episodes | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | percent change | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline. | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | number of micturitions | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 - Baseline)/Baseline | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | percent change | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | number of micturitions | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 - Baseline)/Baseline | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | percent change | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | number of episodes | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 | UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 - Baseline)/Baseline | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | percent change | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | number of episodes | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | percent change | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | number of episodes | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 | Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline | FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | percent change | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 | The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. | FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | USS Sum rating per 24 hours | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
|
| Secondary | Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 | The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 | PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2. | FAS subjects with non-missing Baseline and Week 4 values. | Posted | | Number | | participants | | Baseline, Week 4 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 | PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2. | FAS subjects with non-missing Baseline and Week 12 values (LOCF). | Posted | | Number | | participants | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 | Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. | FAS subjects with non-missing Baseline and Week 4 values. | Posted | | Number | | participants | | Baseline, Week 4 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. | Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. | FAS subjects with non-missing Baseline and Week 12 values (LOCF). | Posted | | Number | | participants | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 | OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 | HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain) | The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on scale | | Baseline, Week 4 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain) | The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain) | The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain) | The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement. | FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 | Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12. | The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | ml | | Baseline, Week 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12 | Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit. | The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis. | Posted | | Median | Full Range | ml/sec | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities) | Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization. | The safety analysis set included all subjects who took at least one dose of study drug. | Posted | | Number | | participants | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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| Secondary | Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) | Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation) | The safety analysis set included all subjects who took at least one dose of study drug. | Posted | | Number | | participants | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Fesoterodine 4mg or 8mg | Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg. | | OG001 | Placebo | Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo. |
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