Trial · NCT01488578
Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
NCT01488578, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan). Trials, record NCT01488578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488578
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
- NCT number
- NCT01488578
- Status
- Completed
- Enrollment
- 11,157 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Overactive Bladder
- Interventions
- Tolterodine tartrate
- First posted
- 2011-12-08
- Last updated
- 2021-01-28
- Results first posted
- 2012-06-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | 12 weeks | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. |
| Primary | Number of Participants Which Was Evaluated as "Degree of Satisfaction". | 12 week | Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. |
| Primary | Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | 12 week | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. |
| Primary | Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | 12 week | The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher. |
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | 12 week | Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. |
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | 12 week | Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. |
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Gender | 12 week | Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. |
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Complications | 12 week | Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. |
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Age | 12 week | Number of participants with responders of tolterodine to determine whether \<65 years or \>=65 years is significant risk factor. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | 12 week | Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | 12 weeks | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol. | participants | NUMBER |
| SECONDARY | Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | 12 week | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| PRIMARY | Number of Participants Which Was Evaluated as Degree of Satisfaction. | 12 week | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| PRIMARY | Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | 12 week | The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.~Number of participants evaluable for which was evaluated effect. | participants | NUMBER |
| SECONDARY | Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | 12 week | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| SECONDARY | Risk Factors for the Proportion of Responders of Tolterodine-Gender | 12 week | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| SECONDARY | Risk Factors for the Proportion of Responders of Tolterodine-Complications | 12 week | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| SECONDARY | Risk Factors for the Proportion of Responders of Tolterodine-Age | 12 week | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | 12 week | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| SECONDARY | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | 12 week | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol. | events | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | Tolterodine Tartrate | 984 | participants | ||
| Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | With Concomitant Drugs | 3483 | participants | ||
| Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | Without Concomitant Drugs | 3053 | participants | ||
| Number of Participants Which Was Evaluated as Degree of Satisfaction. | Tolterodine Tartrate | Satisfied | 5609 | participants | |
| Number of Participants Which Was Evaluated as Degree of Satisfaction. | Tolterodine Tartrate | Dissatisfied | 1033 | participants | |
| Number of Participants Which Was Evaluated as Degree of Satisfaction. | Tolterodine Tartrate | Neither of the above | 963 | participants | |
| Number of Participants Which Was Evaluated as Degree of Satisfaction. | Tolterodine Tartrate | Unknown | 175 | participants | |
| Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Tolterodine Tartrate | Effective | 6536 | participants | |
| Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Tolterodine Tartrate | Not effective | 1244 | participants | |
| Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | With Non-drug Therapies | 317 | participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolterodine Tartrate | 11,157 | |
| Overall Study | COMPLETED | Tolterodine Tartrate | 9,321 | |
| Overall Study | NOT COMPLETED | Tolterodine Tartrate | 1,836 |
Source ClinicalTrials.gov
Adverse events11
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 | Thirst | General disorders | Tolterodine Tartrate | 344 | 9,321 | 344 |
| other | Constipation | Gastrointestinal disorders | Tolterodine Tartrate | 194 | 9,321 | 194 |
| other | Dysuria | Renal and urinary disorders | Tolterodine Tartrate | 165 | 9,321 | 165 |
| serious | Urinary retention | Renal and urinary disorders | Tolterodine Tartrate | 4 | 9,321 | 4 |
| serious | Intestinal obstruction | Gastrointestinal disorders | Tolterodine Tartrate | 2 | 9,321 | 2 |
| serious | Pyelonephritis acute | Infections and infestations | Tolterodine Tartrate | 1 | 9,321 | 1 |
| serious | Dementia | Nervous system disorders | Tolterodine Tartrate | 1 | 9,321 | 1 |
| serious | Dizziness | Nervous system disorders | Tolterodine Tartrate | 1 | 9,321 | 1 |
| serious | Vertigo | Ear and labyrinth disorders | Tolterodine Tartrate | 1 | 9,321 | 1 |
| serious | Rash | Skin and subcutaneous tissue disorders | Tolterodine Tartrate | 1 | 9,321 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolterodine Tartrate | ||
| Total, other adverse events | Tolterodine Tartrate | 703 | 9,321 |
| Total, serious adverse events | Tolterodine Tartrate | 12 | 9,321 |
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Male vs Female: Risk Factors for the Proportion of Responders of Tolterodine-Gender | Trial comparisons |
| With Urinary Urgency vs Without Urinary Urgency: Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | Trial comparisons |
| With Previous Treatment vs Without Previous Treatment: Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | Trial comparisons |
| With Non-drug Therapies vs Without Non-drug Therapies: Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | Trial comparisons |
| With Concomitant Drugs vs Without Concomitant Drugs: Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | Trial comparisons |
| With Complications vs Without Complications: Risk Factors for the Proportion of Responders of Tolterodine-Complications | Trial comparisons |
| With BPH vs Without BPH: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | Trial comparisons |
| <65 Years vs >=65 Years: Risk Factors for the Proportion of Responders of Tolterodine-Age | Trial comparisons |
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/NCT01488578
GET https://conductscience.org/api/trials/v1/NCT01488578/results?page=2