The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501928
Recruitment Status : Completed
First Posted : July 17, 2015
Results First Posted : October 26, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Bladder, Neurogenic
Interventions Drug: Fesoterodine PR 4 mg
Drug: Fesoterodine PR 8 mg
Drug: Fesoterodine BIC 2 mg
Drug: Fesoterodine BIC 4 mg
Enrollment 12
Recruitment Details This (A0221109) was a long term extension (LTE) study only among Japanese participants who participated and completed the precedent study A0221047 (NCT01557244). Per plan, efficacy outcome measures and treatment-emergent adverse events were reported using merged data of studies A0221047 and A0221109.
Pre-assignment Details A0221047 had 2 cohorts. Cohort 1 had an active comparator phase and Cohort 2 had an efficacy phase followed by a safety extension phase for each cohort. Japanese participants from both cohorts, if consented continued in this LTE study and received the same treatment as in A0221047, per investigator judgment on safety and tolerance of participants.
Arm/Group Title Fesoterodine 4 Milligram (mg) Tablet Fesoterodine 8 mg Tablet Oxybutynin Then Fesoterodine 4 mg Tablet Oxybutynin Then Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description In precedent study A0221047, participants of cohort 1, with body weight greater than (>) 25 kilogram (kg), received fesoterodine 4 mg prolonged release (PR) tablet once daily for 24 weeks (12 weeks in each active comparator and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 28 weeks in this LTE study. In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study. In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet in safety extension phase once daily for 12 weeks. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 40 weeks in this LTE study. In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet once daily for 1 week and if tolerated well received 8 mg PR tablet once daily for 11 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 40 weeks in this LTE study. In precedent study A0220147, participants of cohort 2, with body weight less than or equal to (<=) 25 kg, received fesoterodine 2 mg beads-in-capsule (BIC) capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study. In precedent study A0221047, participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Period Title: Overall Study
Started 0 [1] 2 0 [1] 0 [1] 7 3
Completed 0 2 0 0 6 3
Not Completed 0 0 0 0 1 0
Reason Not Completed
Withdrawal By Parent/Guardian             0             0             0             0             1             0
[1]
No participant was assigned to this arm, in this LTE study.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total
Hide Arm/Group Description Japanese participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and for 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study. Japanese participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study A0221047 and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study. Japanese participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study. Total of all reporting groups
Overall Number of Baseline Participants 2 7 3 12
Hide Baseline Analysis Population Description
Baseline characteristics included only those reporting arms in which at least 1 participant was assigned. Analysis population included all enrolled participants who received at least 1 dose of study medication in this LTE study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 7 participants 3 participants 12 participants
13.50  (0.71) 7.86  (1.68) 7.33  (0.58) 8.67  (2.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 7 participants 3 participants 12 participants
Female
2
 100.0%
0
   0.0%
1
  33.3%
3
  25.0%
Male
0
   0.0%
7
 100.0%
2
  66.7%
9
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 7 participants 3 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
7
 100.0%
3
 100.0%
12
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 7 participants 3 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
 100.0%
7
 100.0%
3
 100.0%
12
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. TEAEs were summarized for each cohort (Cohort 1 and Cohort 2, irrespective of treatment received), each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
2
 100.0%
9
  90.0%
2
 100.0%
6
  85.7%
3
 100.0%
11
  91.7%
Participants with SAEs
0
   0.0%
1
  10.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
   8.3%
2.Primary Outcome
Title Change From Baseline in Visual Acuity at Week 12: Study A0221109
Hide Description Visual acuity (VA) was assessed for each eye using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: LogMAR
Right Eye: Baseline 0.27  (0.376) 0.04  (0.137) 0.28  (0.334)
Right Eye: Change at Week 12 0.14  (0.204) -0.03  (0.083) 0.04  (0.067)
Left Eye: Baseline 0.45  (0.350) 0.04  (0.183) 0.63  (0.663)
Left Eye: Change at Week 12 0.03  (0.126) 0.03  (0.116) 0.07  (0.122)
3.Primary Outcome
Title Change From Baseline in Visual Acuity at Week 28: Study A0221109
Hide Description VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: LogMAR
Right Eye 0.00  (0.000) 0.03  (0.118) 0.02  (0.142)
Left Eye 0.31  (0.681) 0.05  (0.057) 0.16  (0.208)
4.Primary Outcome
Title Change From Baseline in Visual Acuity at Final Visit: Study A0221109
Hide Description VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: LogMAR
Right Eye 0.00  (0.000) 0.02  (0.108) 0.02  (0.142)
Left Eye 0.31  (0.681) 0.04  (0.055) 0.16  (0.208)
5.Primary Outcome
Title Change From Baseline in Visual Accommodation at Week 12: Study A0221109
Hide Description The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: centimeter
Right Eye: Baseline Number Analyzed 2 participants 7 participants 3 participants
9.33  (8.014) 8.62  (10.938) 5.56  (4.857)
Right Eye: Change at Week 12 Number Analyzed 2 participants 7 participants 3 participants
2.50  (2.593) 5.86  (13.287) 6.67  (10.990)
Left Eye: Baseline Number Analyzed 2 participants 7 participants 2 participants
14.00  (13.199) 9.86  (13.685) 4.83  (6.835)
Left Eye: Change at Week 12 Number Analyzed 2 participants 7 participants 2 participants
-1.83  (2.593) 3.24  (13.662) 16.17  (23.806)
6.Primary Outcome
Title Change From Baseline in Visual Accommodation at Week 28: Study A0221109
Hide Description The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: centimeter
Right Eye Number Analyzed 2 participants 6 participants 3 participants
5.17  (7.307) 0.78  (2.639) -0.11  (1.836)
Left Eye Number Analyzed 2 participants 6 participants 2 participants
3.17  (5.421) -0.39  (3.803) 0.50  (0.707)
7.Primary Outcome
Title Change From Baseline in Visual Accommodation at Final Visit: Study A0221109
Hide Description The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: centimeter
Right Eye Number Analyzed 2 participants 7 participants 3 participants
5.17  (7.307) 4.38  (9.833) -0.11  (1.836)
Left Eye Number Analyzed 2 participants 7 participants 2 participants
3.17  (5.421) 2.86  (9.263) 0.50  (0.707)
8.Primary Outcome
Title Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Hide Description CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggressive behavior: Baseline 50.0  (0.00) 52.6  (3.82) 50.7  (1.15)
Aggressive behavior: Change at Week 12 0.0  (0.00) -0.1  (3.53) 0.0  (0.00)
Anxious/depressed: Baseline 50.0  (0.00) 52.1  (3.34) 50.7  (0.58)
Anxious/depressed: Change at Week 12 0.0  (0.00) 0.7  (4.11) -0.7  (0.58)
Attention problems: Baseline 50.0  (0.00) 53.6  (3.55) 53.3  (4.93)
Attention problems: Change at week 12 0.0  (0.00) -1.1  (2.34) 0.0  (0.00)
Rule-breaking behavior: Baseline 50.5  (0.71) 52.4  (3.60) 53.3  (5.77)
Rule-breaking behavior: Change at Week 12 0.0  (0.00) -0.3  (4.11) 0.0  (0.00)
Social problems: Baseline 50.0  (0.00) 52.4  (2.70) 54.3  (6.66)
Social problems: Change at Week 12 0.0  (0.00) 0.0  (3.65) 0.7  (1.15)
Somatic complaints: Baseline 51.5  (2.12) 53.4  (5.35) 55.7  (4.62)
Somatic complaints: Change at Week 12 1.5  (2.12) 0.9  (1.46) -2.3  (2.08)
Thought problems: Baseline 50.0  (0.00) 50.9  (1.46) 53.0  (4.36)
Thought problems: Change at Week 12 0.0  (0.00) 0.3  (1.70) 0.0  (0.00)
Withdrawn: Baseline 50.0  (0.00) 53.4  (4.86) 52.7  (4.62)
Withdrawn: Change at Week 12 0.0  (0.00) -1.7  (4.54) 0.0  (0.00)
Externalizing problems: Baseline 37.0  (4.24) 47.6  (8.79) 44.0  (10.00)
Externalizing problems: Change at Week 12 0.0  (0.00) -0.3  (6.07) 0.0  (0.00)
Internalizing problems: Baseline 36.0  (4.24) 49.0  (3.79) 47.7  (7.51)
Internalizing problems: Change at Week 12 3.0  (4.24) 0.4  (5.00) -4.0  (2.00)
Total problems: Baseline 30.5  (2.12) 49.1  (3.67) 46.7  (11.59)
Total problems: Change at Week 12 3.0  (4.24) -1.1  (2.12) 0.3  (1.53)
9.Primary Outcome
Title Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Hide Description CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggressive behavior 0.0  (0.00) -2.2  (3.76) -0.3  (0.58)
Anxious/depressed 0.0  (0.00) -0.7  (4.13) 0.3  (1.53)
Attention problems 0.0  (0.00) -1.0  (2.45) 0.0  (0.00)
Rule-breaking behavior -0.5  (0.71) -1.0  (2.97) 1.3  (2.31)
Social problems 0.0  (0.00) 0.3  (1.63) 1.0  (1.73)
Somatic complaints 0.0  (0.00) 1.2  (1.83) -2.3  (2.08)
Thought problems 0.0  (0.00) -0.2  (0.41) -0.3  (0.58)
Withdrawn 0.0  (0.00) -2.0  (7.04) 0.0  (0.00)
Externalizing problems -3.0  (4.24) -3.5  (5.92) 0.0  (0.00)
Internalizing problems 0.0  (0.00) -2.5  (6.83) -2.7  (3.06)
Total problems -2.5  (3.54) -1.7  (2.94) 1.0  (1.00)
10.Primary Outcome
Title Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Hide Description CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggressive behavior 0.0  (0.00) -1.9  (3.53) -0.3  (0.58)
Anxious/depressed 0.0  (0.00) -0.6  (3.78) 0.3  (1.53)
Attention problems 0.0  (0.00) -0.9  (2.27) 0.0  (0.00)
Rule-breaking behavior -0.5  (0.71) -0.9  (2.73) 1.3  (2.31)
Social problems 0.0  (0.00) 0.3  (1.50) 1.0  (1.73)
Somatic complaints 0.0  (0.00) 1.0  (1.73) -2.3  (2.08)
Thought problems 0.0  (0.00) -0.1  (0.38) -0.3  (0.58)
Withdrawn 0.0  (0.00) -1.7  (6.47) 0.0  (0.00)
Externalizing problems -3.0  (4.24) -3.0  (5.57) 0.0  (0.00)
Internalizing problems 0.0  (0.00) -2.1  (6.31) -2.7  (3.06)
Total problems -2.5  (3.54) -1.4  (2.76) 1.0  (1.00)
11.Primary Outcome
Title Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Hide Description CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggressive behavior: Baseline 0.0  (0.00) 3.4  (3.05) 2.0  (2.00)
Aggressive behavior: Change at Week 12 0.0  (0.00) -0.1  (2.97) 0.0  (0.00)
Anxious/depressed: Baseline 0.0  (0.00) 1.9  (1.57) 1.3  (1.15)
Anxious/depressed: Change at Week 12 0.0  (0.00) 0.3  (1.60) -0.7  (0.58)
Attention problems: Baseline 0.0  (0.00) 3.6  (2.64) 3.0  (3.46)
Attention problems: Change at week 12 0.0  (0.00) -0.6  (1.27) 0.0  (0.00)
Rule-breaking behavior: Baseline 0.5  (0.71) 1.3  (1.50) 1.3  (2.31)
Rule-breaking behavior: Change at Week 12 0.0  (0.00) -0.1  (1.21) 0.0  (0.00)
Social problems: Baseline 0.0  (0.00) 1.6  (1.27) 2.3  (3.21)
Social problems: Change at Week 12 0.0  (0.00) 0.0  (1.63) 0.3  (0.58)
Somatic complaints: Baseline 0.5  (0.71) 1.0  (1.53) 1.7  (1.15)
Somatic complaints: Change at Week 12 0.5  (0.71) 0.3  (0.49) -0.7  (0.58)
Thought problems: Baseline 0.0  (0.00) 0.6  (0.79) 1.3  (1.53)
Thought problems: Change at Week 12 0.0  (0.00) -0.1  (0.69) 0.0  (0.00)
Withdrawn: Baseline 0.0  (0.00) 0.9  (1.21) 0.7  (1.15)
Withdrawn: Change at Week 12 0.0  (0.00) -0.4  (1.13) 0.0  (0.00)
Externalizing problems: Baseline 0.5  (0.71) 4.7  (4.27) 3.3  (4.16)
Externalizing problems: Change at Week 12 0.0  (0.00) -0.3  (3.59) 0.0  (0.00)
Internalizing problems: Baseline 0.5  (0.71) 3.7  (1.38) 3.7  (2.31)
Internalizing problems: Change at Week 12 0.5  (0.71) 0.1  (2.19) -1.3  (0.58)
Total problems: Baseline 1.5  (0.71) 19.1  (5.79) 18.0  (17.78)
Total problems: Change at Week 12 1.0  (1.41) -1.3  (4.07) -0.3  (1.15)
12.Primary Outcome
Title Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Hide Description CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggressive behavior 0.0  (0.00) -1.8  (3.06) -0.3  (0.58)
Anxious/depressed 0.0  (0.00) -0.3  (1.37) 0.0  (1.00)
Attention problems 0.0  (0.00) -0.5  (1.22) 0.0  (0.00)
Rule-breaking behavior -0.5  (0.71) -0.2  (0.98) 0.3  (0.58)
Social problems 0.0  (0.00) 0.2  (0.98) 0.3  (0.58)
Somatic complaints 0.0  (0.00) 0.3  (0.52) -0.7  (0.58)
Thought problems 0.0  (0.00) -0.2  (0.41) -0.3  (0.58)
Withdrawn 0.0  (0.00) -0.5  (1.76) 0.0  (0.00)
Externalizing problems -0.5  (0.71) -2.0  (3.58) 0.0  (0.00)
Internalizing problems 0.0  (0.00) -0.5  (2.88) -0.7  (0.58)
Total problems -0.5  (0.71) -2.7  (4.63) 0.7  (0.58)
13.Primary Outcome
Title Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Hide Description CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggressive behavior 0.0  (0.00) -1.6  (2.88) -0.3  (0.58)
Anxious/depressed 0.0  (0.00) -0.3  (1.25) 0.0  (1.00)
Attention problems 0.0  (0.00) -0.4  (1.13) 0.0  (0.00)
Rule-breaking behavior -0.5  (0.71) -0.1  (0.90) 0.3  (0.58)
Social problems 0.0  (0.00) 0.1  (0.90) 0.3  (0.58)
Somatic complaints 0.0  (0.00) 0.3  (0.49) -0.7  (0.58)
Thought problems 0.0  (0.00) -0.1  (0.38) -0.3  (0.58)
Withdrawn 0.0  (0.00) -0.4  (1.62) 0.0  (0.00)
Externalizing problems -0.5  (0.71) -1.7  (3.35) 0.0  (0.00)
Internalizing problems 0.0  (0.00) -0.4  (2.64) -0.7  (0.58)
Total problems -0.5  (0.71) -2.3  (4.35) 0.7  (0.58)
14.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here "Overall Number of Participants Analyzed= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 5 3
Mean (Standard Deviation)
Unit of Measure: seconds
Dominant hand: Baseline 43.0  (23.44) 39.3  (15.18)
Dominant hand: Change at Week 12 0.8  (6.72) -0.3  (15.28)
Non-dominant hand: Baseline 33.4  (10.74) 52.0  (19.67)
Non-dominant hand: Change at Week 12 8.2  (19.93) -1.3  (9.45)
15.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 4 3
Mean (Standard Deviation)
Unit of Measure: seconds
Dominant hand 4.5  (2.38) 3.7  (4.04)
Non-dominant hand 6.3  (7.37) -7.7  (10.26)
16.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 5 3
Mean (Standard Deviation)
Unit of Measure: seconds
Dominant hand 0.8  (8.53) 3.7  (4.04)
Non-dominant hand 4.4  (7.60) -7.7  (10.26)
17.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: seconds
Dominant hand: Baseline 59.5  (6.36) 107.5  (75.66)
Dominant hand: Change at Week 12 0.0  (2.83) -11.5  (13.44)
Non-dominant hand: Baseline 60.5  (6.36) 145.5  (132.23)
Non-dominant hand: Change at Week 12 -0.5  (4.95) -2.0  (9.90)
18.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in Study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: seconds
Dominant hand 2.0  (7.07) -14.0  (24.04)
Non-dominant hand -1.0  (2.83) -35.0  (48.08)
19.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: seconds
Dominant hand 2.08  (7.07) -14.0  (24.04)
Non-dominant hand -1.0  (2.83) -35.0  (48.08)
20.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in Study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 5 3
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand: Baseline 0.2  (0.45) 0.0  (0.00)
Dominant hand: Change at Week 12 0.2  (0.45) 0.0  (0.00)
Non-dominant hand: Baseline 0.0  (0.00) 0.0  (0.00)
Non-dominant hand: Change at Week 12 0.6  (1.34) 0.0  (0.00)
21.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 4 3
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.3  (0.96) 0.0  (0.00)
Non-dominant hand 0.0  (0.00) 0.0  (0.00)
22.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of Study A0221109 only.
Time Frame A0221109: Baseline, final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 5 3
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.2  (0.84) 0.0  (0.00)
Non-dominant hand 0.0  (0.00) 0.0  (0.00)
23.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand: Baseline 0.0  (0.00) 0.5  (0.71)
Dominant hand: Change at Week 12 0.0  (0.00) -0.5  (0.71)
Non-dominant hand: Baseline 0.0  (0.00) 0.5  (0.71)
Non-dominant hand: Change at Week 12 0.0  (0.00) -0.5  (0.71)
24.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.0  (0.00) 0.0  (1.41)
Non-dominant hand 0.0  (0.00) -0.5  (0.71)
25.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.0  (0.00) 0.0  (1.41)
Non-dominant hand 0.0  (0.00) -0.5  (0.71)
26.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 5 3
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand: Baseline 10.0  (0.00) 10.0  (0.00)
Dominant hand: Change at Week 12 0.0  (0.00) 0.0  (0.00)
Non-dominant hand: Baseline 10.0  (0.00) 10.0  (0.00)
Non-dominant hand: Change at Week 12 0.0  (0.00) 0.0  (0.00)
27.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 4 3
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.0  (0.00) 0.0  (0.00)
Non-dominant hand 0.0  (0.00) 0.0  (0.00)
28.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 5 3
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.0  (0.00) 0.0  (0.00)
Non-dominant hand 0.0  (0.00) 0.0  (0.00)
29.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand: Baseline 25.0  (0.00) 25.0  (0.00)
Dominant hand: Change at Week 12 0.0  (0.00) 0.0  (0.00)
Non-dominant hand: Baseline 25.0  (0.00) 25.0  (0.00)
Non-dominant hand: Change at Week 12 0.0  (0.00) 0.0  (0.00)
30.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.0  (0.00) 0.0  (0.00)
Non-dominant hand 0.0  (0.00) 0.0  (0.00)
31.Primary Outcome
Title Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109
Hide Description The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: pegs
Dominant hand 0.0  (0.00) 0.0  (0.00)
Non-dominant hand 0.0  (0.00) 0.0  (0.00)
32.Primary Outcome
Title Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109
Hide Description Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury
Systolic blood pressure 6.0  (4.24) 2.1  (9.65) 5.0  (14.11)
Diastolic blood pressure 10.5  (4.95) -0.9  (8.90) 6.3  (15.31)
33.Primary Outcome
Title Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109
Hide Description Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury
Systolic blood pressure 8.5  (16.26) 5.7  (11.18) 9.7  (2.52)
Diastolic blood pressure 12.0  (4.24) 5.3  (9.03) 10.7  (2.52)
34.Primary Outcome
Title Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109
Hide Description Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury
Systolic blood pressure 8.5  (16.26) 5.1  (10.30) 9.7  (2.52)
Diastolic blood pressure 12.0  (4.24) 4.6  (8.48) 10.7  (2.52)
35.Primary Outcome
Title Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109
Hide Description Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: beats per minute
0.0  (18.38) 2.4  (12.53) -8.0  (2.00)
36.Primary Outcome
Title Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109
Hide Description Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: beats per minute
-3.5  (6.36) -2.7  (8.82) -3.7  (9.61)
37.Primary Outcome
Title Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109
Hide Description Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Mean (Standard Deviation)
Unit of Measure: beats per minute
-3.5  (6.36) -1.4  (8.70) -3.7  (9.61)
38.Primary Outcome
Title Number of Participants With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109
Hide Description UTI data were summarized for each cohort, each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  10.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
   8.3%
39.Primary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities
Hide Description Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN); platelets<0.5*LLN>1.75*upper limit of normal (ULN); leukocytes <0.6*LLN>1.5*ULN; lymphocytes, neutrophils <0.8*LLN >1.2*UL; basophils, eosinophils, monocytes >1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin >1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein, albumin <0.8*LLN >1.2*ULN; blood urea nitrogen, creatinine >1.3*ULN; urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN; potassium, chloride, bicarbonate <0.9*LLN>1.1*ULN; glucose <0.6*LLN>1.5*ULN; creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, glucose, ketones, protein, hemoglobin, nitrite, leukocyte esterase >=1; erythrocytes, leukocytes >=20; epithelial cells >=6, bacteria >20, hyaline casts >1. Data for this outcome was planned to be analysed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in Study A0221109.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 2 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
6
  85.7%
2
  66.7%
40.Primary Outcome
Title Change From Baseline in Post-Void Residual (PVR) Volume at Week 12: Study A0221109
Hide Description Post-void residual volume was assessed by an ultrasound. PVR volume was assessed only in participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. All participants performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
41.Primary Outcome
Title Change From Baseline in Post-Void Residual (PVR) Volume at Week 28: Study A0221109
Hide Description Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. All participants performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
42.Primary Outcome
Title Change From Baseline in Post-Void Residual (PVR) Volume at Final Visit: Study A0221109
Hide Description Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Time Frame A0221109: Baseline, final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. All participants performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
Arm/Group Title Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
Hide Arm/Group Description:
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
43.Secondary Outcome
Title Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description Maximum cystometric bladder capacity was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O). Maximum cystometric bladder capacity was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: milliliter
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
181.0  (28.28) 135.5  (45.21) 181.0  (28.28) 149.7  (38.49) 102.3  (48.95) 143.1  (45.37)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
153.0  (56.57) 42.9  (31.01) 153.0  (56.57) 37.6  (28.83) 55.3  (38.76) 61.3  (53.98)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
121.5  (30.41) 37.9  (53.99) 121.5  (30.41) 32.8  (52.42) 48.0  (67.55) 53.1  (59.74)
Change at Final Visit Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
121.5  (30.41) 37.9  (53.99) 121.5  (30.41) 32.8  (52.42) 48.0  (67.55) 53.1  (59.74)
44.Secondary Outcome
Title Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description Detrusor pressure (cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing. Detrusor pressure was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: cm H2O
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
29.0  (8.49) 40.2  (31.34) 29.0  (8.49) 32.4  (11.57) 58.3  (57.55) 38.3  (28.79)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
-5.5  (0.71) -13.7  (24.90) -5.5  (0.71) -6.0  (7.85) -31.7  (43.73) -12.3  (22.74)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
-7.0  (0.00) -4.3  (23.93) -7.0  (0.00) -2.8  (2.86) -7.3  (47.44) -4.8  (21.43)
Change at Final Visit Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
-7.0  (0.00) -4.3  (23.93) -7.0  (0.00) -2.8  (2.86) -7.3  (47.44) -4.8  (21.43)
45.Secondary Outcome
Title Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description Participants with presence of IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
1
  50.0%
10
 100.0%
1
  50.0%
7
 100.0%
3
 100.0%
11
  91.7%
Week 12
0
   0.0%
7
  70.0%
0
   0.0%
4
  57.1%
3
 100.0%
7
  58.3%
Week 28
0
   0.0%
8
  80.0%
0
   0.0%
5
  71.4%
3
 100.0%
8
  66.7%
Final Visit
0
   0.0%
8
  80.0%
0
   0.0%
5
  71.4%
3
 100.0%
8
  66.7%
46.Secondary Outcome
Title Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description Bladder volume at first IDC was measured using urodynamic testing. Bladder volume at first IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit. Overall number of participants analyzed=participants evaluable for this outcome measure. Number Analyzed=participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 1 10 1 7 3 11
Mean (Standard Deviation)
Unit of Measure: milliliter
Baseline Number Analyzed 1 participants 10 participants 1 participants 7 participants 3 participants 11 participants
175.0 48.8  (31.65) 175.0 48.1  (36.57) 50.3  (22.14) 60.3  (48.47)
Change at Week 12 Number Analyzed 0 participants 7 participants 0 participants 4 participants 3 participants 7 participants
95.0  (53.88) 113.8  (68.55) 70.0  (4.58) 95.0  (53.88)
Change at Week 28 Number Analyzed 0 participants 8 participants 0 participants 5 participants 3 participants 8 participants
50.4  (36.38) 38.6  (24.46) 70.0  (50.11) 50.4  (36.38)
Change at Final Visit Number Analyzed 0 participants 8 participants 0 participants 5 participants 3 participants 8 participants
50.4  (36.38) 38.6  (24.46) 70.0  (50.11) 50.4  (36.38)
47.Secondary Outcome
Title Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). Bladder Compliance was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: milliliter per cm H2O
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
7.00  (2.828) 6.97  (5.124) 7.00  (2.828) 8.16  (5.668) 4.20  (2.307) 6.98  (4.712)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
9.00  (7.071) 20.06  (46.151) 9.00  (7.071) 23.34  (55.493) 12.40  (14.855) 18.22  (42.021)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
8.65  (6.152) 13.22  (16.721) 8.65  (6.152) 13.18  (18.628) 13.30  (15.836) 12.39  (15.194)
Change at Final Visit Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
8.65  (6.152) 13.22  (16.721) 8.65  (6.152) 13.18  (18.628) 13.30  (15.836) 12.39  (15.194)
48.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 micturitions at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was analyzed. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arms "Cohort 1", "Fesoterodine 8 mg Tablet" and "Fesoterodine 4 mg Capsule" had >0 micturitions at baseline.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 0 4 0 4 0 4
Mean (Standard Deviation)
Unit of Measure: micturitions per 24 hours
Baseline 4.58  (4.541) 4.58  (4.541) 4.58  (4.541)
Change at Week 12 -1.50  (1.036) -1.50  (1.036) -1.50  (1.036)
Change at Week 28 -1.08  (0.631) -1.08  (0.631) -1.08  (0.631)
Change at Final Visit -1.08  (0.631) -1.08  (0.631) -1.08  (0.631)
49.Secondary Outcome
Title Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: catheterizations per 24 hours
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
5.33  (0.943) 4.47  (1.390) 5.33  (0.943) 4.24  (1.641) 5.00  (0.000) 4.61  (1.332)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
0.00  (0.471) 0.05  (0.357) 0.00  (0.471) 0.03  (0.420) 0.11  (0.192) 0.04  (0.353)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
0.33  (0.000) -0.09  (0.278) 0.33  (0.000) -0.19  (0.267) 0.11  (0.192) -0.02  (0.302)
Change at Final Visit Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
0.33  (0.000) -0.12  (0.273) 0.33  (0.000) -0.21  (0.249) 0.11  (0.192) -0.04  (0.303)
50.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions or Catheterizations Combined Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean number of micturitions and catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour (hr) period. This outcome measure was only calculated for participants with >0 micturitions or catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: micturitions or catheterizations/24 hr
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
5.33  (0.943) 6.30  (2.808) 5.33  (0.943) 6.86  (3.259) 5.00  (0.000) 6.14  (2.584)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
0.00  (0.471) -0.55  (1.131) 0.00  (0.471) -0.83  (1.264) 0.11  (0.192) -0.46  (1.055)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
0.33  (0.000) -0.57  (0.741) 0.33  (0.000) -0.92  (0.665) 0.11  (0.192) -0.41  (0.758)
Change at Final Visit Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
0.33  (0.000) -0.55  (0.703) 0.33  (0.000) -0.83  (0.645) 0.11  (0.192) -0.40  (0.723)
51.Secondary Outcome
Title Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: incontinence episodes per 24 hours
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
1.17  (0.236) 3.60  (2.298) 1.17  (0.236) 3.48  (2.768) 3.89  (0.770) 3.19  (2.285)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
0.50  (0.236) -0.18  (1.726) 0.50  (0.236) -0.26  (2.074) 0.00  (0.667) -0.07  (1.586)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
1.83  (0.707) -0.31  (1.501) 1.83  (0.707) -0.42  (1.577) -0.11  (1.644) 0.08  (1.615)
Change at Final Visit Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
1.83  (0.707) 0.08  (1.894) 1.83  (0.707) 0.17  (2.110) -0.11  (1.644) 0.38  (1.856)
52.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for sensate participants with >0 urgency episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was analyzed. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No sensate participants for reporting arms "Cohort 1" and "Fesoterodine 8 mg Tablet" had >0 urgency episodes at baseline.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 0 3 0 2 1 3
Mean (Standard Deviation)
Unit of Measure: urgency episodes per 24 hours
Baseline 0.61  (0.347) 0.75  (0.354) 0.33 0.61  (0.347)
Change at Week 12 -0.61  (0.347) -0.75  (0.354) -0.33 -0.61  (0.347)
Change at Week 28 -0.61  (0.347) -0.75  (0.354) -0.33 -0.61  (0.347)
Change at Final Visit -0.61  (0.347) -0.75  (0.354) -0.33 -0.61  (0.347)
53.Secondary Outcome
Title Change From Baseline in Mean Volume Voided Per Micturition at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume >0. This outcome measure included only participants who actually had the records of volume voided per micturition. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was analyzed. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arms "Cohort 1", "Fesoterodine 8 mg Tablet" and "Fesoterodine 4 mg Capsule" had the records of volume voided per micturition.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 0 2 0 2 0 2
Mean (Standard Deviation)
Unit of Measure: milliliter per micturition
Baseline 73.42  (42.309) 73.42  (42.309) 73.42  (42.309)
Change at Week 12 15.77  (6.924) 15.77  (6.924) 15.77  (6.924)
Change at Week 28 4.75  (14.496) 4.75  (14.496) 4.75  (14.496)
Change at Final Visit 4.75  (14.496) 4.75  (14.496) 4.75  (14.496)
54.Secondary Outcome
Title Change From Baseline in Mean Volume Voided Per Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume >0. This outcome measure included only participants who actually had the records of volume voided per catherization. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: milliliter per catheterization
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
198.75  (44.194) 58.31  (40.187) 198.75  (44.194) 48.76  (39.230) 80.58  (39.841) 81.72  (66.988)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
-0.92  (21.095) 20.66  (21.024) -0.92  (21.095) 17.90  (17.038) 27.08  (32.086) 17.06  (21.739)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
-29.42  (12.139) 11.58  (27.064) -29.42  (12.139) 8.72  (33.245) 17.28  (9.659) 4.12  (29.591)
Change at Final Visit Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
-29.42  (12.139) 11.58  (27.064) -29.42  (12.139) 8.72  (33.245) 17.28  (9.659) 4.12  (29.591)
55.Secondary Outcome
Title Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Hide Description The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume >0. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Time Frame Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description:
Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
Overall Number of Participants Analyzed 2 10 2 7 3 12
Mean (Standard Deviation)
Unit of Measure: mL per micturition or catheterization
Baseline Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
198.75  (44.194) 65.68  (34.769) 198.75  (44.194) 59.29  (33.550) 80.58  (39.841) 87.86  (62.045)
Change at Week 12 Number Analyzed 2 participants 10 participants 2 participants 7 participants 3 participants 12 participants
-0.92  (21.095) 17.88  (17.597) -0.92  (21.095) 13.94  (7.801) 27.08  (32.086) 14.75  (18.638)
Change at Week 28 Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
-29.42  (12.139) 12.34  (26.812) -29.42  (12.139) 9.86  (33.029) 17.28  (9.659) 4.75  (29.583)
Change at Final Visit Number Analyzed 2 participants 9 participants 2 participants 6 participants 3 participants 11 participants
-29.42  (12.139) 12.34  (26.812) -29.42  (12.139) 9.86  (33.029) 17.28  (9.659) 4.75  (29.583)
Time Frame Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
 
Arm/Group Title Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Hide Arm/Group Description Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study. Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study. Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study. Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study. Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study. Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
All-Cause Mortality
Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/10 (0.00%)   0/2 (0.00%)   0/7 (0.00%)   0/3 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   1/10 (10.00%)   0/2 (0.00%)   1/7 (14.29%)   0/3 (0.00%)   1/12 (8.33%) 
Infections and infestations             
Urinary tract infection * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA v22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2 Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Total of Treatment Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   9/10 (90.00%)   2/2 (100.00%)   6/7 (85.71%)   3/3 (100.00%)   11/12 (91.67%) 
Eye disorders             
Astigmatism * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Conjunctivitis allergic * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Myopia * 1  0/2 (0.00%)  2/10 (20.00%)  0/2 (0.00%)  0/7 (0.00%)  2/3 (66.67%)  2/12 (16.67%) 
Strabismus * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Visual acuity reduced * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders             
Anal fissure * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Aphthous ulcer * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Diarrhoea * 1  1/2 (50.00%)  1/10 (10.00%)  1/2 (50.00%)  1/7 (14.29%)  0/3 (0.00%)  2/12 (16.67%) 
Faeces soft * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
General disorders             
Fatigue * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Pyrexia * 1  1/2 (50.00%)  2/10 (20.00%)  1/2 (50.00%)  1/7 (14.29%)  1/3 (33.33%)  3/12 (25.00%) 
Immune system disorders             
Seasonal allergy * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Infections and infestations             
Abscess limb * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Asymptomatic bacteriuria * 1  0/2 (0.00%)  4/10 (40.00%)  0/2 (0.00%)  3/7 (42.86%)  1/3 (33.33%)  4/12 (33.33%) 
Bronchitis * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Conjunctivitis bacterial * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/12 (8.33%) 
Impetigo * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Influenza * 1  0/2 (0.00%)  2/10 (20.00%)  0/2 (0.00%)  2/7 (28.57%)  0/3 (0.00%)  2/12 (16.67%) 
Nasopharyngitis * 1  1/2 (50.00%)  6/10 (60.00%)  1/2 (50.00%)  4/7 (57.14%)  2/3 (66.67%)  7/12 (58.33%) 
Oral herpes * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/12 (8.33%) 
Pharyngitis * 1  0/2 (0.00%)  2/10 (20.00%)  0/2 (0.00%)  1/7 (14.29%)  1/3 (33.33%)  2/12 (16.67%) 
Sinusitis * 1  0/2 (0.00%)  2/10 (20.00%)  0/2 (0.00%)  1/7 (14.29%)  1/3 (33.33%)  2/12 (16.67%) 
Injury, poisoning and procedural complications             
Chillblains * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Investigations             
Urodynamics measurement abnormal * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders             
Spinal deformity * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Nervous system disorders             
Headache * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Product Issues             
Device malfunction * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Renal and urinary disorders             
Renal failure * 1  1/2 (50.00%)  0/10 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/12 (8.33%) 
Urinary incontinence * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders             
Asthma * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Upper respiratory tract inflammation * 1  0/2 (0.00%)  2/10 (20.00%)  0/2 (0.00%)  1/7 (14.29%)  1/3 (33.33%)  2/12 (16.67%) 
Skin and subcutaneous tissue disorders             
Decubitus ulcer * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Dermal cyst * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/12 (8.33%) 
Eczema * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
Seborrhoeic dermatitis * 1  0/2 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA v22.1
*
Indicates events were collected by non-systematic assessment
Prioritization of outcome measures was based on study team's discretion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02501928    
Other Study ID Numbers: A0221109
First Submitted: June 1, 2015
First Posted: July 17, 2015
Results First Submitted: September 25, 2020
Results First Posted: October 26, 2020
Last Update Posted: November 30, 2020