Trial · NCT01936870
Drug Use Investigation for Toviaz
NCT01936870, Completed, Pfizer; results first posted 2017-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Drug Use Investigation for Toviaz. Trials, record NCT01936870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01936870
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Investigation for Toviaz
- NCT number
- NCT01936870
- Status
- Completed
- Enrollment
- 2,521 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Overactive Bladder (OAB)
- Interventions
- Fesoterodine (Toviaz)
- First posted
- 2013-09-06
- Last updated
- 2021-06-11
- Results first posted
- 2017-04-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events | 12 Weeks | A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator. |
| Primary | Clinical Efficacy Rate | 12 Weeks | Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment. |
| Secondary | Number of Participants With Treatment-Related Serious Adverse Events | 12 Weeks | A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 12 Weeks | A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator. |
| Secondary | Number of Participants With Adverse Events Related to Cognitive Function Disorder | 12 Weeks | An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ). |
| Secondary | Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks | Baseline, 12 Weeks | Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors | 12 Weeks | Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors | 12 Weeks | Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg | 12 Weeks | A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator. |
| Secondary | Satisfaction Rate | 12 Weeks | Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Related Adverse Events | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinical Efficacy Rate | 12 Weeks | The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Serious Adverse Events | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events Related to Cognitive Function Disorder | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks | Baseline, 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Participants with observed change in MMSE score were included in table. | Scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Number Analyzed signifies those participants who were evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Number Analyzed signifies those participants who were evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg | 12 Weeks | The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Number Analyzed signifies those participants who were evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Satisfaction Rate | 12 Weeks | The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use. | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | Fesoterodine Fumarate | 415 | Participants | ||
| Clinical Efficacy Rate | Fesoterodine Fumarate | 74.8 | 95% Confidence Interval 73.0 to 76.5 | Percentage of participants | |
| Number of Participants With Treatment-Related Serious Adverse Events | Fesoterodine Fumarate | 8 | Participants | ||
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Fesoterodine Fumarate | 27 | Participants | ||
| Number of Participants With Adverse Events Related to Cognitive Function Disorder | Fesoterodine Fumarate | 2 | Participants | ||
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks | Fesoterodine Fumarate | 0.4 | Standard Deviation 1.29 | Scale | |
| Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors | Fesoterodine Fumarate | Received Concomitant CYP3A4 Inhibitors | 6 | Participants | |
| Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors | Fesoterodine Fumarate | Not Received Concomitant CYP3A4 Inhibitors | 409 | Participants | |
| Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors | Fesoterodine Fumarate | Received Concomitant CYP2D6 Inhibitors | 11 | Participants | |
| Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors | Fesoterodine Fumarate | Not Received Concomitant CYP2D6 Inhibitors | 404 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fesoterodine Fumarate | 2,492 | |
| Overall Study | COMPLETED | Fesoterodine Fumarate | 2,303 | |
| Overall Study | NOT COMPLETED | Fesoterodine Fumarate | 189 |
Source ClinicalTrials.gov
Adverse events17
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 | Dry mouth | Gastrointestinal disorders | Fesoterodine Fumarate | 36 | 2,303 | |
| other | Constipation | Gastrointestinal disorders | Fesoterodine Fumarate | 72 | 2,303 | |
| other | Urinary retention | Renal and urinary disorders | Fesoterodine Fumarate | 24 | 2,303 | |
| other | Dysuria | Renal and urinary disorders | Fesoterodine Fumarate | 63 | 2,303 | |
| other | Thirst | General disorders | Fesoterodine Fumarate | 166 | 2,303 | |
| serious | Pneumonia | Infections and infestations | Fesoterodine Fumarate | 1 | 2,303 | |
| serious | Loss of consciousness | Nervous system disorders | Fesoterodine Fumarate | 1 | 2,303 | |
| serious | Cerebral infarction | Nervous system disorders | Fesoterodine Fumarate | 1 | 2,303 | |
| serious | Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Fesoterodine Fumarate | 1 | 2,303 | |
| serious | Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Fesoterodine Fumarate | 1 | 2,303 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fesoterodine Fumarate | ||
| Total, other adverse events | Fesoterodine Fumarate | 361 | 2,303 |
| Total, serious adverse events | Fesoterodine Fumarate | 12 | 2,303 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01936870
GET https://conductscience.org/api/trials/v1/NCT01936870/registered