Trial · NCT00688688
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00688688, Phase 3, Completed, Astellas Pharma Inc; results first posted 2012-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder. Trials, record NCT00688688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00688688
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
- NCT number
- NCT00688688
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,792 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Mirabegron, Tolterodine, Placebo to Mirabegron, Placebo to Tolterodine
- First posted
- 2008-06-03
- Last updated
- 2024-11-20
- Other registries' IDs
- eudract:2007-001452-39
- Results first posted
- 2012-10-19
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. | An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Baseline and Months 1, 3, 6, 9 and 12 | The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender \& geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Baseline and Months 1, 3, 6, 9 and 12 | Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender \& geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS means are from an ANCOVA model with treatment group, previous study history, gender \& geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS means are from an ANCOVA model with treatment group, previous study history, gender \& geographical regions as fixed factors and baseline as a covariate. |
| Secondary | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Months 1, 3, 6, 9 and 12 | The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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 and Severity of Treatment-emergent Adverse Events (TEAEs) | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. | The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit. | urgency incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit. | urgency episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit | pads | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit. | nocturia episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Months 1, 3, 6, 9 and 12 | The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis. | percentage of participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group588
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 and Severity of Treatment-emergent Adverse Events (TEAEs) | Mirabegron 50 mg | Mild adverse events | 222 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mirabegron 100 mg | Mild adverse events | 240 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Tolterodine ER 4 mg | Mild adverse events | 251 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mirabegron 50 mg | Moderate adverse events | 212 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mirabegron 100 mg | Moderate adverse events | 211 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Tolterodine ER 4 mg | Moderate adverse events | 218 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mirabegron 50 mg | Severe adverse events | 51 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mirabegron 100 mg | Severe adverse events | 52 | participants | |
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Tolterodine ER 4 mg | Severe adverse events | 39 | participants | |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Mirabegron 50 mg | Month 1 [N=786; 797; 786] | -0.94 | Standard Error 0.069 | micturitions |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron 50 mg | 815 | |
| Overall Study | STARTED | Mirabegron 100 mg | 824 | |
| Overall Study | STARTED | Tolterodine ER 4 mg | 813 | |
| Overall Study | Safety Analysis Set (SAF) | Mirabegron 50 mg | 812 | |
| Overall Study | Safety Analysis Set (SAF) | Mirabegron 100 mg | 820 | |
| Overall Study | Safety Analysis Set (SAF) | Tolterodine ER 4 mg | 812 | |
| Overall Study | Full Analysis Set (FAS) | Mirabegron 50 mg | 789 | |
| Overall Study | Full Analysis Set (FAS) | Mirabegron 100 mg | 802 | |
| Overall Study | Full Analysis Set (FAS) | Tolterodine ER 4 mg | 791 | |
| Overall Study | Full Analysis Set Incontinence (FAS-I) | Mirabegron 50 mg | 479 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events471
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 | Hypertension | Vascular disorders | Mirabegron 50 mg | 74 | 812 | |
| other | Hypertension | Vascular disorders | Mirabegron 100 mg | 80 | 820 | |
| other | Hypertension | Vascular disorders | Tolterodine ER 4 mg | 78 | 812 | |
| other | Urinary tract infection | Infections and infestations | Mirabegron 50 mg | 48 | 812 | |
| other | Urinary tract infection | Infections and infestations | Mirabegron 100 mg | 45 | 820 | |
| other | Urinary tract infection | Infections and infestations | Tolterodine ER 4 mg | 52 | 812 | |
| other | Dry mouth | Gastrointestinal disorders | Mirabegron 50 mg | 23 | 812 | |
| other | Dry mouth | Gastrointestinal disorders | Mirabegron 100 mg | 19 | 820 | |
| other | Dry mouth | Gastrointestinal disorders | Tolterodine ER 4 mg | 70 | 812 | |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Mirabegron 50 mg | 0 | 812 |
1 to 10 of 471Source ClinicalTrials.gov
See all 471 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron 50 mg | ||
| Total, all-cause mortality | Mirabegron 100 mg | ||
| Total, all-cause mortality | Tolterodine ER 4 mg | ||
| Total, other adverse events | Mirabegron 50 mg | 136 | 812 |
| Total, other adverse events | Mirabegron 100 mg | 137 | 820 |
| Total, other adverse events | Tolterodine ER 4 mg | 181 | 812 |
| Total, serious adverse events | Mirabegron 50 mg | 42 | 812 |
| Total, serious adverse events | Mirabegron 100 mg | 51 | 820 |
| Total, serious adverse events | Tolterodine ER 4 mg | 44 | 812 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23195283 | BACKGROUND |
Source PubMed
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.
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Read this trial from software.
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