Trial · NCT00662909
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00662909, Phase 3, Completed, Astellas Pharma Inc; results first posted 2012-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder. Trials, record NCT00662909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00662909
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
- NCT number
- NCT00662909
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,149 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Mirabegron, Placebo
- First posted
- 2008-04-21
- Last updated
- 2024-11-20
- Results first posted
- 2012-10-17
- 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 outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 12 (Final Visit) | 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 before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Primary | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Baseline and Week 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 before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | Baseline and Week 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 before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4 | The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4 | The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Weeks 8 and 12 | The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Baseline and Weeks 8 and 12 | The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Baseline and Weeks 4, 8 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 before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The involuntary leakage of urine accompanied by 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 while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Secondary | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 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 while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 12 (Final Visit) | The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was used in this analysis. | Incontinence episodes | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Baseline and Week 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis. | Micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | Baseline and Week 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4 | The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not used in this analysis. | Incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not used in this analysis. | Micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Weeks 8 and 12 | The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as N. LOCF was not utilized. | Incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Baseline and Weeks 8 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not used in this analysis. The number of patients included in the calculation for each time point is noted as N. | Micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Baseline and Weeks 4, 8 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 post baseline micturition measurement in the visit diary \& at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point. | Urgency incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point. | Urgency episodes | LEAST_SQUARES_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group456
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Placebo | -1.13 | Standard Error 0.112 | Incontinence episodes | |
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Mirabegron 50 mg | -1.47 | Standard Error 0.114 | Incontinence episodes | |
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Mirabegron 100 mg | -1.63 | Standard Error 0.117 | Incontinence episodes | |
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Placebo | -1.05 | Standard Error 0.132 | Micturitions | |
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Mirabegron 50 mg | -1.66 | Standard Error 0.133 | Micturitions | |
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Mirabegron 100 mg | -1.75 | Standard Error 0.135 | Micturitions | |
| Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | Placebo | 7.0 | Standard Error 2.41 | mL | |
| Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | Mirabegron 50 mg | 18.2 | Standard Error 2.44 | mL | |
| Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | Mirabegron 100 mg | 18.0 | Standard Error 2.47 | mL | |
| Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | Placebo | -0.72 | Standard Error 0.116 | Incontinence episodes |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 454 | |
| Overall Study | STARTED | Mirabegron 50 mg | 442 | |
| Overall Study | STARTED | Mirabegron 100 mg | 433 | |
| Overall Study | Safety Analysis Set (SAF) | Placebo | 453 | |
| Overall Study | Safety Analysis Set (SAF) | Mirabegron 50 mg | 442 | |
| Overall Study | Safety Analysis Set (SAF) | Mirabegron 100 mg | 433 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 433 | |
| Overall Study | Full Analysis Set (FAS) | Mirabegron 50 mg | 425 | |
| Overall Study | Full Analysis Set (FAS) | Mirabegron 100 mg | 412 | |
| Overall Study | Full Analysis Set Incontinence (FAS-I) | Placebo | 325 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events123
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 | Placebo | 30 | 453 | |
| other | Hypertension | Vascular disorders | Mirabegron 50 mg | 27 | 442 | |
| other | Hypertension | Vascular disorders | Mirabegron 100 mg | 21 | 433 | |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 453 | |
| serious | Atrial fibrillation | Cardiac disorders | Mirabegron 50 mg | 1 | 442 | |
| serious | Atrial fibrillation | Cardiac disorders | Mirabegron 100 mg | 1 | 433 | |
| serious | Angina pectoris | Cardiac disorders | Placebo | 0 | 453 | |
| serious | Angina pectoris | Cardiac disorders | Mirabegron 50 mg | 1 | 442 | |
| serious | Angina pectoris | Cardiac disorders | Mirabegron 100 mg | 0 | 433 | |
| serious | Cardiac failure | Cardiac disorders | Placebo | 0 | 453 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Mirabegron 50 mg | ||
| Total, all-cause mortality | Mirabegron 100 mg | ||
| Total, other adverse events | Placebo | 30 | 453 |
| Total, other adverse events | Mirabegron 50 mg | 27 | 442 |
| Total, other adverse events | Mirabegron 100 mg | 21 | 433 |
| Total, serious adverse events | Placebo | 9 | 453 |
| Total, serious adverse events | Mirabegron 50 mg | 11 | 442 |
| Total, serious adverse events | Mirabegron 100 mg | 14 | 433 |
Source ClinicalTrials.gov
Papers2
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.
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GET https://conductscience.org/api/trials/v1/NCT00662909
GET https://conductscience.org/api/trials/v1/NCT00662909/registered?page=2