A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00911937

Collaborator

(none)

963

Enrollment

112

Locations

Arms

Duration (Months)

8.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Fesoterodine Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

963 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine	Drug: Fesoterodine Fesoterodine 4mg and 8 mg tablets taken daily.
Placebo Comparator: Placebo	Drug: Placebo Placebo sham 4mg and 8 mg tables taken daily.

Arm

Intervention/Treatment

Experimental: Fesoterodine

Drug: Fesoterodine

Fesoterodine 4mg and 8 mg tablets taken daily.

Placebo Comparator: Placebo

Drug: Placebo

Placebo sham 4mg and 8 mg tables taken daily.

Outcome Measures

Primary Outcome Measures

Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours [Baseline]
Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 [Baseline and Week 12]
Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

Secondary Outcome Measures

Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 [Baseline and Week 4]
Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Number of Nocturnal Micturitions Per 24 Hours [Baseline]
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Mean Number of Micturitions Per 24 Hours [Baseline]
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Number of Micturition-related Urgency Episodes Per 24 Hours [Baseline]
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [Baseline]
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Nocturnal Frequency-urgency Sum Rating Per 24 Hours [Baseline]
Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Frequency-urgency Sum Rating Per 24 Hours [Baseline]
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 [Baseline, Week 4 and 12]
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Mean Voided Volume Per Nocturnal Micturition [Baseline]
Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12 [Baseline and Week 12]
Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Mean Voided Volume Per Micturition [Baseline]
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Change From Baseline in Mean Voided Volume Per Micturition at Week 12 [Baseline and Week 12]
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [Baseline]
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 [Baseline, Week 4 and 12]
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) [Baseline]
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 [Baseline, Week 4 and 12]
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Mobile	Alabama	United States	36608
2	Pfizer Investigational Site	Goodyear	Arizona	United States	85395
3	Pfizer Investigational Site	Litchfield Park	Arizona	United States	85340
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85020
5	Pfizer Investigational Site	Tucson	Arizona	United States	85741
6	Pfizer Investigational Site	Little Rock	Arkansas	United States	72205
7	Pfizer Investigational Site	Fresno	California	United States	93720
8	Pfizer Investigational Site	La Mesa	California	United States	91942
9	Pfizer Investigational Site	Newport Beach	California	United States	92660
10	Pfizer Investigational Site	Roseville	California	United States	95661
11	Pfizer Investigational Site	Sacramento	California	United States	95825
12	Pfizer Investigational Site	San Diego	California	United States	92103-6204
13	Pfizer Investigational Site	San Diego	California	United States	92103
14	Pfizer Investigational Site	San Diego	California	United States	92108
15	Pfizer Investigational Site	Tarzana	California	United States	91356
16	Pfizer Investigational Site	Denver	Colorado	United States	80218
17	Pfizer Investigational Site	Denver	Colorado	United States	80220
18	Pfizer Investigational Site	Farmington	Connecticut	United States	06032
19	Pfizer Investigational Site	New Britain	Connecticut	United States	06052
20	Pfizer Investigational Site	Norwalk	Connecticut	United States	06850
21	Pfizer Investigational Site	Dover	Delaware	United States	19904
22	Pfizer Investigational Site	Bonita Springs	Florida	United States	34134
23	Pfizer Investigational Site	Brooksville	Florida	United States	34601
24	Pfizer Investigational Site	DeFuniak Springs	Florida	United States	32435
25	Pfizer Investigational Site	Destin	Florida	United States	32541
26	Pfizer Investigational Site	Leesburg	Florida	United States	34748
27	Pfizer Investigational Site	Naples	Florida	United States	34102
28	Pfizer Investigational Site	Ocala	Florida	United States	34471
29	Pfizer Investigational Site	Ocala	Florida	United States	34474
30	Pfizer Investigational Site	Pembroke Pines	Florida	United States	33024
31	Pfizer Investigational Site	Saint Petersburg	Florida	United States	33709
32	Pfizer Investigational Site	South Miami	Florida	United States	33143
33	Pfizer Investigational Site	Tallahassee	Florida	United States	32308
34	Pfizer Investigational Site	Tampa	Florida	United States	33606
35	Pfizer Investigational Site	Atlanta	Georgia	United States	30329-5102
36	Pfizer Investigational Site	Coeur d'Alene	Idaho	United States	83814
37	Pfizer Investigational Site	Chicago	Illinois	United States	60634
38	Pfizer Investigational Site	Chicago	Illinois	United States	60654
39	Pfizer Investigational Site	Fort Wayne	Indiana	United States	46825
40	Pfizer Investigational Site	Jeffersonville	Indiana	United States	47130
41	Pfizer Investigational Site	Iowa City	Iowa	United States	52242
42	Pfizer Investigational Site	West Des Moines	Iowa	United States	50266
43	Pfizer Investigational Site	Newton	Kansas	United States	67114
44	Pfizer Investigational Site	Overland Park	Kansas	United States	66202
45	Pfizer Investigational Site	Overland Park	Kansas	United States	66210
46	Pfizer Investigational Site	Overland Park	Kansas	United States	66211
47	Pfizer Investigational Site	Pratt	Kansas	United States	67124
48	Pfizer Investigational Site	Madisonville	Kentucky	United States	42431
49	Pfizer Investigational Site	Mount Sterling	Kentucky	United States	40353
50	Pfizer Investigational Site	Shreveport	Louisiana	United States	71106
51	Pfizer Investigational Site	Annapolis	Maryland	United States	21401
52	Pfizer Investigational Site	Fall River	Massachusetts	United States	02720
53	Pfizer Investigational Site	Hyannis	Massachusetts	United States	02601
54	Pfizer Investigational Site	Milford	Massachusetts	United States	01757
55	Pfizer Investigational Site	New Bedford	Massachusetts	United States	02740
56	Pfizer Investigational Site	Watertown	Massachusetts	United States	02472
57	Pfizer Investigational Site	Troy	Michigan	United States	48098
58	Pfizer Investigational Site	Chaska	Minnesota	United States	55318
59	Pfizer Investigational Site	Olive Branch	Mississippi	United States	38654
60	Pfizer Investigational Site	Saint Louis	Missouri	United States	63110
61	Pfizer Investigational Site	Lincoln	Nebraska	United States	68510
62	Pfizer Investigational Site	Omaha	Nebraska	United States	68114
63	Pfizer Investigational Site	Hamilton	New Jersey	United States	08690
64	Pfizer Investigational Site	Brooklyn	New York	United States	11215
65	Pfizer Investigational Site	Garden City	New York	United States	11530
66	Pfizer Investigational Site	Kingston	New York	United States	12401
67	Pfizer Investigational Site	Manlius	New York	United States	13104
68	Pfizer Investigational Site	New York	New York	United States	10016
69	Pfizer Investigational Site	Poughkeepsie	New York	United States	12601
70	Pfizer Investigational Site	Burlington	North Carolina	United States	27215
71	Pfizer Investigational Site	Cary	North Carolina	United States	27518
72	Pfizer Investigational Site	Charlotte	North Carolina	United States	28207
73	Pfizer Investigational Site	Concord	North Carolina	United States	28025
74	Pfizer Investigational Site	Huntersville	North Carolina	United States	28078
75	Pfizer Investigational Site	Salisbury	North Carolina	United States	28144
76	Pfizer Investigational Site	Fargo	North Dakota	United States	58103
77	Pfizer Investigational Site	Akron	Ohio	United States	44311
78	Pfizer Investigational Site	Cincinnati	Ohio	United States	45249
79	Pfizer Investigational Site	Columbus	Ohio	United States	43214
80	Pfizer Investigational Site	Columbus	Ohio	United States	43221
81	Pfizer Investigational Site	Dayton	Ohio	United States	45439
82	Pfizer Investigational Site	Westerville	Ohio	United States	43081
83	Pfizer Investigational Site	Portland	Oregon	United States	97225
84	Pfizer Investigational Site	Bala-Cynwyd	Pennsylvania	United States	19004
85	Pfizer Investigational Site	Bridgeville	Pennsylvania	United States	15017
86	Pfizer Investigational Site	Lansdale	Pennsylvania	United States	19446
87	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19114
88	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15236
89	Pfizer Investigational Site	Sellersville	Pennsylvania	United States	18960
90	Pfizer Investigational Site	East Greenwich	Rhode Island	United States	02818
91	Pfizer Investigational Site	Pawtucket	Rhode Island	United States	02860
92	Pfizer Investigational Site	Warwick	Rhode Island	United States	02886
93	Pfizer Investigational Site	Anderson	South Carolina	United States	29621
94	Pfizer Investigational Site	Mount Pleasant	South Carolina	United States	29464
95	Pfizer Investigational Site	Bristol	Tennessee	United States	37620
96	Pfizer Investigational Site	Kingsport	Tennessee	United States	37660
97	Pfizer Investigational Site	Knoxville	Tennessee	United States	37920
98	Pfizer Investigational Site	Milan	Tennessee	United States	38358
99	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
100	Pfizer Investigational Site	New Tazewell	Tennessee	United States	37825
101	Pfizer Investigational Site	Bryan	Texas	United States	77802
102	Pfizer Investigational Site	Dallas	Texas	United States	75231
103	Pfizer Investigational Site	Houston	Texas	United States	77024
104	Pfizer Investigational Site	Houston	Texas	United States	77030
105	Pfizer Investigational Site	Houston	Texas	United States	77079
106	Pfizer Investigational Site	Plano	Texas	United States	75024
107	Pfizer Investigational Site	Norfolk	Virginia	United States	23502
108	Pfizer Investigational Site	Richmond	Virginia	United States	23294
109	Pfizer Investigational Site	Mountlake Terrace	Washington	United States	98043
110	Pfizer Investigational Site	Seattle	Washington	United States	98104
111	Pfizer Investigational Site	Spokane	Washington	United States	99207
112	Pfizer Investigational Site	Menomonee Falls	Wisconsin	United States	53051

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00911937

Other Study ID Numbers:

A0221048

First Posted:

Jun 3, 2009

Last Update Posted:

Dec 4, 2018

Last Verified:

Nov 1, 2018

Keywords provided by Pfizer

incontinence OAB urgency nocturia

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Fesoterodine

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Period Title: Overall Study
STARTED	487	476
Treated	474	463
COMPLETED	400	381
NOT COMPLETED	87	95

Baseline Characteristics

Arm/Group Title	Placebo	Fesoterodine	Total
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.	Total of all reporting groups
Overall Participants	474	463	937
Age, Customized (participants) [Number]
18 to 44 years	74 15.6%	84 18.1%	158 16.9%
45 to 64 years	257 54.2%	214 46.2%	471 50.3%
At least 65 years	143 30.2%	165 35.6%	308 32.9%
Sex: Female, Male (Count of Participants)
Female	312 65.8%	313 67.6%	625 66.7%
Male	162 34.2%	150 32.4%	312 33.3%

Outcome Measures

1. Primary Outcome

Title	Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours
Description	Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N'(number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Mean (Standard Deviation) [episodes per 24 hours]	2.93 (0.98)	2.91 (0.90)

2. Primary Outcome

Title	Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
Description	Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
FAS population. Last observation carried forward (LOCF) method was used to impute missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Least Squares Mean (Standard Error) [episodes per 24 hours]	-1.06 (0.06)	-1.29 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0030
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95% -0.37 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.08
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4
Description	Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	443	415
Least Squares Mean (Standard Error) [episodes per 24 hours]	-0.70 (0.05)	-0.83 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0772
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95% -0.27 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

4. Secondary Outcome

Title	Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12
Description	Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-24.1 (38.1)	-28.4 (38.7)
Change at Week 12	-36.2 (37.8)	-44.5 (39.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

5. Secondary Outcome

Title	Number of Nocturnal Micturitions Per 24 Hours
Description	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Mean (Standard Deviation) [micturitions per 24 hours]	3.19 (1.05)	3.15 (0.99)

6. Secondary Outcome

Title	Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Description	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-0.48 (0.05)	-0.59 (0.05)
Change at Week 12	-0.84 (0.05)	-1.02 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0827
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95% -0.25 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0112
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least Squares mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95% -0.33 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

7. Secondary Outcome

Title	Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Description	Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-15.1 (33.1)	-18.9 (31.8)
Change at Week 12	-26.2 (35.7)	-32.2 (35.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0023
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

8. Secondary Outcome

Title	Mean Number of Micturitions Per 24 Hours
Description	Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Mean (Standard Deviation) [micturitions per 24 hours]	12.33 (3.58)	12.30 (3.26)

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
Description	Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-0.90 (0.11)	-1.35 (0.11)
Change at Week 12	-1.86 (0.13)	-2.42 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0026
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95% -0.74 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.15
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0014
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95% -0.90 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

10. Secondary Outcome

Title	Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
Description	Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-6.7 (17.8)	-10.3 (17.7)
Change at Week 12	-14.2 (21.3)	-18.7 (20.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

11. Secondary Outcome

Title	Number of Micturition-related Urgency Episodes Per 24 Hours
Description	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Mean (Standard Deviation) [episodes per 24 hours]	10.04 (4.01)	9.84 (3.62)

12. Secondary Outcome

Title	Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Description	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-1.59 (0.16)	-2.18 (0.17)
Change at Week 12	-2.72 (0.18)	-3.50 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0072
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95% -1.03 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.22
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0009
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95% -1.25 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.24
	Estimation Comments

13. Secondary Outcome

Title	Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Description	Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-14.9 (33.9)	-20.0 (37.2)
Change at Week 12	-25.7 (35.8)	-34.2 (42.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0041
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

14. Secondary Outcome

Title	Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	184	157
Mean (Standard Deviation) [episodes per 24 hours]	2.23 (2.49)	2.20 (2.55)

15. Secondary Outcome

Title	Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	184	157
Change at Week 4	-0.76 (0.12)	-0.90 (0.13)
Change at Week 12	-1.08 (0.11)	-1.26 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3954
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95% -0.47 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2166
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95% -0.48 to 0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.15
	Estimation Comments

16. Secondary Outcome

Title	Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Description	Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	184	157
Change at Week 4	-34.2 (90.0)	-34.8 (102.6)
Change at Week 12	-58.2 (103.9)	-59.2 (71.3)

17. Secondary Outcome

Title	Nocturnal Frequency-urgency Sum Rating Per 24 Hours
Description	Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	441	420
Mean (Standard Deviation) [units on a scale]	10.91 (4.14)	10.60 (3.74)

18. Secondary Outcome

Title	Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Description	Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	441	420
Change at Week 4	-2.07 (0.17)	-2.46 (0.18)
Change at Week 12	-3.36 (0.18)	-4.08 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1018
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95% -0.85 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0027
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 95% -1.20 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.24
	Estimation Comments

19. Secondary Outcome

Title	Frequency-urgency Sum Rating Per 24 Hours
Description	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Mean (Standard Deviation) [units on a scale]	39.54 (13.83)	38.73 (12.32)

20. Secondary Outcome

Title	Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Description	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	445	421
Change at Week 4	-4.88 (0.46)	-6.44 (0.48)
Change at Week 12	-8.69 (0.51)	-11.12 (0.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0131
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.56
	Confidence Interval	(2-Sided) 95% -2.79 to -0.33
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-2.43
	Confidence Interval	(2-Sided) 95% -3.78 to -1.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.69
	Estimation Comments

21. Secondary Outcome

Title	Mean Voided Volume Per Nocturnal Micturition
Description	Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	369	345
Mean (Standard Deviation) [milliliter (mL)]	172.53 (95.47)	173.14 (95.50)

22. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12
Description	Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	369	345
Least Squares Mean (Standard Error) [mL]	15.49 (5.43)	16.81 (5.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8547
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% -12.82 to 15.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.20
	Estimation Comments

23. Secondary Outcome

Title	Mean Voided Volume Per Micturition
Description	Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	396	372
Mean (Standard Deviation) [mL]	154.56 (65.87)	158.38 (67.40)

24. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition at Week 12
Description	Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	396	372
Least Squares Mean (Standard Error) [mL]	5.51 (3.17)	4.65 (3.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8396
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95% -9.14 to 7.44
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.22
	Estimation Comments

25. Secondary Outcome

Title	Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Description	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	416	395
Mean (Standard Deviation) [units on a scale]	50.46 (19.54)	48.84 (19.33)

26. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
Description	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	416	395
Change at Week 4	NA (NA)	NA (NA)
Change at Week 12	-15.91 (0.94)	-20.28 (0.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-4.37
	Confidence Interval	(2-Sided) 95% -6.84 to -1.89
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.26
	Estimation Comments

27. Secondary Outcome

Title	Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Description	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	416	393
Concern domain	63.29 (24.66)	64.30 (23.08)
Coping domain	62.19 (26.51)	62.26 (26.12)
Sleep domain	47.45 (23.25)	49.65 (23.04)
Social interaction domain	82.22 (21.36)	82.48 (20.09)
Total	63.56 (21.56)	64.37 (20.61)

28. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
Description	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description
FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Measure Participants	416	393
Change at Week 4: concern domain	NA (NA)	NA (NA)
Change at Week 4: coping domain	NA (NA)	NA (NA)
Change at Week 4: sleep domain	NA (NA)	NA (NA)
Change at Week 4: social interaction domain	NA (NA)	NA (NA)
Change at Week 4: total	NA (NA)	NA (NA)
Change at Week 12: concern domain	14.63 (1.00)	18.05 (1.04)
Change at Week 12: coping domain	15.17 (1.01)	18.32 (1.04)
Change at Week 12: sleep domain	18.97 (1.13)	22.45 (1.17)
Change at Week 12: social interaction domain	8.27 (0.69)	10.13 (0.72)
Change at Week 12: total	14.39 (0.87)	17.42 (0.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0110
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.42
	Confidence Interval	(2-Sided) 95% 0.79 to 6.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.34
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0200
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.14
	Confidence Interval	(2-Sided) 95% 0.50 to 5.79
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.35
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0218
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.48
	Confidence Interval	(2-Sided) 95% 0.51 to 6.45
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.51
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0458
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	1.86
	Confidence Interval	(2-Sided) 95% 0.03 to 3.68
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.93
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0100
	Comments	Statistical testing, two-sided, was done at alpha = 0.05 level.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.02
	Confidence Interval	(2-Sided) 95% 0.72 to 5.32
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.17
	Estimation Comments

Adverse Events

	Placebo		Fesoterodine
Time Frame
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Placebo		Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.		Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/474 (1.9%)		5/463 (1.1%)
Eye disorders
Retinal detachment	1/474 (0.2%)		0/463 (0%)
General disorders
Chest pain	2/474 (0.4%)		0/463 (0%)
Non-cardiac chest pain	1/474 (0.2%)		0/463 (0%)
Infections and infestations
Diverticulitis	1/474 (0.2%)		0/463 (0%)
Pneumonia	1/474 (0.2%)		0/463 (0%)
Septic arthritis staphylococcal	0/474 (0%)		1/463 (0.2%)
Injury, poisoning and procedural complications
Ankle fracture	0/474 (0%)		1/463 (0.2%)
Fall	0/474 (0%)		1/463 (0.2%)
Hip fracture	0/474 (0%)		1/463 (0.2%)
Tibia fracture	0/474 (0%)		1/463 (0.2%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/474 (0%)		1/463 (0.2%)
Musculoskeletal and connective tissue disorders
Back pain	1/474 (0.2%)		0/463 (0%)
Osteoarthritis	1/474 (0.2%)		0/463 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma	0/474 (0%)		1/463 (0.2%)
Nervous system disorders
Cerebral haemorrhage	1/474 (0.2%)		0/463 (0%)
Renal and urinary disorders
Renal failure acute	0/474 (0%)		1/463 (0.2%)
Other (Not Including Serious) Adverse Events
	Placebo		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	148/474 (31.2%)		187/463 (40.4%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/474 (0.2%)		0/463 (0%)
Cardiac disorders
Cardiomegaly	1/474 (0.2%)		0/463 (0%)
Mitral valve prolapse	1/474 (0.2%)		0/463 (0%)
Palpitations	1/474 (0.2%)		1/463 (0.2%)
Ear and labyrinth disorders
Otorrhoea	0/474 (0%)		1/463 (0.2%)
Endocrine disorders
Hypothyroidism	0/474 (0%)		1/463 (0.2%)
Eye disorders
Cataract	2/474 (0.4%)		1/463 (0.2%)
Dry eye	2/474 (0.4%)		9/463 (1.9%)
Vision blurred	1/474 (0.2%)		4/463 (0.9%)
Gastrointestinal disorders
Abdominal discomfort	2/474 (0.4%)		0/463 (0%)
Abdominal distension	2/474 (0.4%)		0/463 (0%)
Abdominal pain	1/474 (0.2%)		4/463 (0.9%)
Abdominal pain upper	1/474 (0.2%)		2/463 (0.4%)
Aphthous stomatitis	1/474 (0.2%)		0/463 (0%)
Bowel movement irregularity	1/474 (0.2%)		0/463 (0%)
Colitis	0/474 (0%)		1/463 (0.2%)
Constipation	7/474 (1.5%)		15/463 (3.2%)
Diarrhoea	5/474 (1.1%)		3/463 (0.6%)
Dry mouth	36/474 (7.6%)		98/463 (21.2%)
Dyspepsia	2/474 (0.4%)		5/463 (1.1%)
Dysphagia	0/474 (0%)		1/463 (0.2%)
Faeces hard	1/474 (0.2%)		0/463 (0%)
Flatulence	1/474 (0.2%)		1/463 (0.2%)
Gastritis	0/474 (0%)		1/463 (0.2%)
Gastrooesophageal reflux disease	0/474 (0%)		2/463 (0.4%)
Haemorrhoids	0/474 (0%)		1/463 (0.2%)
Large intestine perforation	1/474 (0.2%)		0/463 (0%)
Lip dry	0/474 (0%)		1/463 (0.2%)
Nausea	7/474 (1.5%)		6/463 (1.3%)
Rectal prolapse	0/474 (0%)		1/463 (0.2%)
Stomatitis	0/474 (0%)		1/463 (0.2%)
Vomiting	2/474 (0.4%)		2/463 (0.4%)
General disorders
Asthenia	1/474 (0.2%)		2/463 (0.4%)
Fatigue	2/474 (0.4%)		5/463 (1.1%)
Feeling abnormal	0/474 (0%)		1/463 (0.2%)
Gait disturbance	0/474 (0%)		1/463 (0.2%)
Oedema	0/474 (0%)		1/463 (0.2%)
Oedema peripheral	2/474 (0.4%)		2/463 (0.4%)
Infections and infestations
Acute sinusitis	0/474 (0%)		1/463 (0.2%)
Bronchitis	0/474 (0%)		1/463 (0.2%)
Candidiasis	1/474 (0.2%)		0/463 (0%)
Cellulitis	2/474 (0.4%)		1/463 (0.2%)
Cystitis	0/474 (0%)		2/463 (0.4%)
Diverticulitis	0/474 (0%)		1/463 (0.2%)
Gastroenteritis	1/474 (0.2%)		2/463 (0.4%)
Gastroenteritis viral	0/474 (0%)		1/463 (0.2%)
Herpes zoster	0/474 (0%)		2/463 (0.4%)
Infected bites	1/474 (0.2%)		0/463 (0%)
Influenza	3/474 (0.6%)		3/463 (0.6%)
Kidney infection	1/474 (0.2%)		0/463 (0%)
Lyme disease	1/474 (0.2%)		0/463 (0%)
Nasopharyngitis	6/474 (1.3%)		4/463 (0.9%)
Otitis media	1/474 (0.2%)		0/463 (0%)
Pharyngitis	2/474 (0.4%)		1/463 (0.2%)
Pharyngitis streptococcal	0/474 (0%)		1/463 (0.2%)
Pneumonia	1/474 (0.2%)		0/463 (0%)
Pneumonia primary atypical	0/474 (0%)		1/463 (0.2%)
Rhinitis	1/474 (0.2%)		0/463 (0%)
Sinusitis	8/474 (1.7%)		6/463 (1.3%)
Tonsillitis	1/474 (0.2%)		0/463 (0%)
Tooth infection	0/474 (0%)		1/463 (0.2%)
Upper respiratory tract infection	4/474 (0.8%)		5/463 (1.1%)
Urinary tract infection	8/474 (1.7%)		9/463 (1.9%)
Vaginitis bacterial	1/474 (0.2%)		0/463 (0%)
Viral infection	1/474 (0.2%)		0/463 (0%)
Vulvovaginal mycotic infection	1/474 (0.2%)		0/463 (0%)
Injury, poisoning and procedural complications
Arthropod bite	1/474 (0.2%)		0/463 (0%)
Bite	1/474 (0.2%)		0/463 (0%)
Contusion	1/474 (0.2%)		1/463 (0.2%)
Excoriation	1/474 (0.2%)		0/463 (0%)
Fall	2/474 (0.4%)		1/463 (0.2%)
Foot fracture	0/474 (0%)		1/463 (0.2%)
Hand fracture	1/474 (0.2%)		0/463 (0%)
Incision site pain	1/474 (0.2%)		0/463 (0%)
Joint injury	1/474 (0.2%)		0/463 (0%)
Joint sprain	2/474 (0.4%)		0/463 (0%)
Laceration	1/474 (0.2%)		0/463 (0%)
Ligament rupture	1/474 (0.2%)		0/463 (0%)
Limb injury	1/474 (0.2%)		0/463 (0%)
Muscle injury	0/474 (0%)		1/463 (0.2%)
Muscle strain	1/474 (0.2%)		2/463 (0.4%)
Periorbital haematoma	0/474 (0%)		1/463 (0.2%)
Procedural pain	0/474 (0%)		1/463 (0.2%)
Investigations
Blood cholesterol increased	1/474 (0.2%)		0/463 (0%)
Blood glucose decreased	0/474 (0%)		1/463 (0.2%)
Blood pressure increased	0/474 (0%)		2/463 (0.4%)
Body temperature increased	1/474 (0.2%)		0/463 (0%)
Urine output decreased	0/474 (0%)		1/463 (0.2%)
Weight decreased	1/474 (0.2%)		0/463 (0%)
Weight increased	2/474 (0.4%)		0/463 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	2/474 (0.4%)		0/463 (0%)
Hyperlipidaemia	0/474 (0%)		1/463 (0.2%)
Hypertriglyceridaemia	0/474 (0%)		1/463 (0.2%)
Hypokalaemia	1/474 (0.2%)		0/463 (0%)
Hypomagnesaemia	1/474 (0.2%)		0/463 (0%)
Pica	0/474 (0%)		1/463 (0.2%)
Polydipsia	0/474 (0%)		1/463 (0.2%)
Type 2 diabetes mellitus	0/474 (0%)		2/463 (0.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/474 (0.4%)		3/463 (0.6%)
Arthritis	0/474 (0%)		1/463 (0.2%)
Back pain	6/474 (1.3%)		2/463 (0.4%)
Bursitis	0/474 (0%)		1/463 (0.2%)
Exostosis	1/474 (0.2%)		0/463 (0%)
Flank pain	0/474 (0%)		3/463 (0.6%)
Joint swelling	1/474 (0.2%)		0/463 (0%)
Muscle spasms	1/474 (0.2%)		2/463 (0.4%)
Muscular weakness	0/474 (0%)		1/463 (0.2%)
Musculoskeletal pain	1/474 (0.2%)		0/463 (0%)
Myalgia	1/474 (0.2%)		2/463 (0.4%)
Myositis	0/474 (0%)		1/463 (0.2%)
Neck pain	0/474 (0%)		1/463 (0.2%)
Osteoarthritis	1/474 (0.2%)		1/463 (0.2%)
Pain in extremity	1/474 (0.2%)		2/463 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/474 (0%)		1/463 (0.2%)
Uterine leiomyoma	1/474 (0.2%)		0/463 (0%)
Nervous system disorders
Amnesia	0/474 (0%)		1/463 (0.2%)
Dizziness	2/474 (0.4%)		6/463 (1.3%)
Dysarthria	1/474 (0.2%)		0/463 (0%)
Headache	5/474 (1.1%)		11/463 (2.4%)
Hypoaesthesia	1/474 (0.2%)		0/463 (0%)
Lethargy	0/474 (0%)		1/463 (0.2%)
Memory impairment	0/474 (0%)		1/463 (0.2%)
Migraine	1/474 (0.2%)		0/463 (0%)
Nerve compression	0/474 (0%)		1/463 (0.2%)
Paraesthesia	0/474 (0%)		1/463 (0.2%)
Sinus headache	1/474 (0.2%)		0/463 (0%)
Somnolence	4/474 (0.8%)		1/463 (0.2%)
Syncope	0/474 (0%)		1/463 (0.2%)
Tremor	0/474 (0%)		1/463 (0.2%)
Psychiatric disorders
Abnormal dreams	2/474 (0.4%)		0/463 (0%)
Anxiety	2/474 (0.4%)		0/463 (0%)
Depression	1/474 (0.2%)		2/463 (0.4%)
Initial insomnia	1/474 (0.2%)		0/463 (0%)
Insomnia	3/474 (0.6%)		5/463 (1.1%)
Renal and urinary disorders
Dysuria	1/474 (0.2%)		2/463 (0.4%)
Haematuria	0/474 (0%)		1/463 (0.2%)
Micturition urgency	1/474 (0.2%)		1/463 (0.2%)
Nephrolithiasis	0/474 (0%)		1/463 (0.2%)
Pollakiuria	1/474 (0.2%)		0/463 (0%)
Polyuria	0/474 (0%)		1/463 (0.2%)
Urinary hesitation	0/474 (0%)		2/463 (0.4%)
Urinary incontinence	0/474 (0%)		1/463 (0.2%)
Urinary retention	1/474 (0.2%)		3/463 (0.6%)
Urine flow decreased	0/474 (0%)		1/463 (0.2%)
Reproductive system and breast disorders
Breast pain	1/474 (0.2%)		0/463 (0%)
Prostatitis	1/474 (0.2%)		0/463 (0%)
Vaginal haemorrhage	1/474 (0.2%)		0/463 (0%)
Vulvovaginal pruritus	1/474 (0.2%)		0/463 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/474 (0.2%)		1/463 (0.2%)
Atelectasis	1/474 (0.2%)		0/463 (0%)
Chronic obstructive pulmonary disease	0/474 (0%)		1/463 (0.2%)
Cough	2/474 (0.4%)		1/463 (0.2%)
Dry throat	0/474 (0%)		3/463 (0.6%)
Dysphonia	0/474 (0%)		2/463 (0.4%)
Dyspnoea	0/474 (0%)		1/463 (0.2%)
Epistaxis	0/474 (0%)		1/463 (0.2%)
Nasal congestion	0/474 (0%)		3/463 (0.6%)
Nasal dryness	0/474 (0%)		3/463 (0.6%)
Oropharyngeal pain	1/474 (0.2%)		3/463 (0.6%)
Pleural effusion	1/474 (0.2%)		0/463 (0%)
Respiratory disorder	1/474 (0.2%)		0/463 (0%)
Respiratory tract congestion	1/474 (0.2%)		0/463 (0%)
Rhinorrhoea	0/474 (0%)		2/463 (0.4%)
Sinus congestion	2/474 (0.4%)		0/463 (0%)
Sleep apnoea syndrome	1/474 (0.2%)		1/463 (0.2%)
Throat irritation	0/474 (0%)		1/463 (0.2%)
Upper-airway cough syndrome	1/474 (0.2%)		1/463 (0.2%)
Skin and subcutaneous tissue disorders
Dermatitis	1/474 (0.2%)		0/463 (0%)
Dermatitis contact	0/474 (0%)		1/463 (0.2%)
Dry skin	1/474 (0.2%)		1/463 (0.2%)
Eczema	0/474 (0%)		1/463 (0.2%)
Increased tendency to bruise	1/474 (0.2%)		0/463 (0%)
Night sweats	1/474 (0.2%)		0/463 (0%)
Onychoclasis	1/474 (0.2%)		0/463 (0%)
Pruritus generalised	0/474 (0%)		1/463 (0.2%)
Rash	2/474 (0.4%)		2/463 (0.4%)
Urticaria	2/474 (0.4%)		1/463 (0.2%)
Surgical and medical procedures
Tooth extraction	1/474 (0.2%)		0/463 (0%)
Vascular disorders
Flushing	0/474 (0%)		1/463 (0.2%)
Haematoma	1/474 (0.2%)		0/463 (0%)
Hypertension	1/474 (0.2%)		3/463 (0.6%)
Hypotension	1/474 (0.2%)		1/463 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00911937

Other Study ID Numbers:

A0221048

First Posted:

Jun 3, 2009

Last Update Posted:

Dec 4, 2018

Last Verified:

Nov 1, 2018