Trial · NCT01302067
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
NCT01302067, Phase 4, Completed, Pfizer; results first posted 2013-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine. Trials, record NCT01302067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01302067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
- NCT number
- NCT01302067
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,012 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Overactive Bladder
- Interventions
- Fesoterodine 8mg, Fesoterodine 4mg, Placebo
- First posted
- 2011-02-23
- Last updated
- 2014-03-26
- Results first posted
- 2013-12-24
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Week 12 | UUI episodes were defined as those with the Urinary Sensation Scale (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. |
| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | Week 4 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Week 12 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Secondary | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | Week 4 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Secondary | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. | Week 12 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Secondary | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. | Week 4 | 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. |
| Secondary | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. | Week 4 | 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. |
| Secondary | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. | Week 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. |
| Secondary | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | Week 4 | 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. |
| Secondary | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | Week 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Week 12 | Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI \>0 per 24 hours \& non-missing change from BL to Week 12 were included. | Episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | Week 4 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 4. | Episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Week 12 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 12. | Episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | Week 4 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 4. | Episodes per 24 hours | MEDIAN |
| SECONDARY | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. | Week 12 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 12. | Episodes per 24 hours | MEDIAN |
| SECONDARY | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. | Week 4 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI \>0 per 24 hours and non-missing change from BL to Week 4. | Episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. | Week 4 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI \>0 per 24 hours and non-missing change from BL to Week 4. | Episodes per 24 hours | MEDIAN |
| SECONDARY | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. | Week 12 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI \>0 per 24 hours and non-missing change from BL to Week 12. | Episodes per 24 hours | MEDIAN |
| SECONDARY | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | Week 4 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes \>0 per 24 hours and non-missing change from BL to Week 4. | Episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | Week 12 | The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes \>0 per 24 hours and non-missing change from BL to Week 12. | Episodes per 24 hours | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Fesoterodine 4 Milligram (mg) | -2.85 | Standard Error 0.09 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Placebo | -2.22 | Standard Error 0.12 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Fesoterodine 8 mg | -3.12 | Standard Error 0.09 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | Fesoterodine 4 Milligram (mg) | -1.95 | Standard Error 0.13 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | Placebo | -1.19 | Standard Error 0.16 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | Fesoterodine 8 mg | -2.33 | Standard Error 0.13 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Fesoterodine 4 Milligram (mg) | -2.45 | Standard Error 0.13 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Placebo | -1.58 | Standard Error 0.17 | Episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Fesoterodine 8 mg | -2.97 | Standard Error 0.13 | Episodes per 24 hours | |
| Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | Fesoterodine 4 Milligram (mg) | -14.58 | Full Range -65.71 to 96.30 | Episodes per 24 hours |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fesoterodine 4 Milligram (mg) | 790 | |
| Overall Study | STARTED | Placebo | 386 | |
| Overall Study | STARTED | Fesoterodine 8 mg | 779 | |
| Overall Study | COMPLETED | Fesoterodine 4 Milligram (mg) | 712 | |
| Overall Study | COMPLETED | Placebo | 352 | |
| Overall Study | COMPLETED | Fesoterodine 8 mg | 681 | |
| Overall Study | NOT COMPLETED | Fesoterodine 4 Milligram (mg) | 78 | |
| Overall Study | NOT COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | Fesoterodine 8 mg | 98 |
Source ClinicalTrials.gov
Adverse events996
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Fesoterodine 4 Milligram (mg) | 1 | 790 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 1 | 386 | |
| other | Anemia | Blood and lymphatic system disorders | Fesoterodine 8 mg | 2 | 779 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Fesoterodine 4 Milligram (mg) | 1 | 790 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Placebo | 0 | 386 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Fesoterodine 8 mg | 0 | 779 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Fesoterodine 4 Milligram (mg) | 2 | 790 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 386 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Fesoterodine 8 mg | 0 | 779 | |
| other | Atrial fibrillation | Cardiac disorders | Fesoterodine 4 Milligram (mg) | 1 | 790 |
1 to 10 of 996Source ClinicalTrials.gov
See all 996 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fesoterodine 4 Milligram (mg) | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Fesoterodine 8 mg | ||
| Total, other adverse events | Fesoterodine 4 Milligram (mg) | 297 | 790 |
| Total, other adverse events | Placebo | 103 | 386 |
| Total, other adverse events | Fesoterodine 8 mg | 349 | 779 |
| Total, serious adverse events | Fesoterodine 4 Milligram (mg) | 10 | 790 |
| Total, serious adverse events | Placebo | 11 | 386 |
| Total, serious adverse events | Fesoterodine 8 mg | 10 | 779 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01302067
GET https://conductscience.org/api/trials/v1/NCT01302067/registered?page=2