Trial · NCT00689104

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

NCT00689104, 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. Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder. Trials, record NCT00689104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689104

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT number: NCT00689104
Status: Completed
Phases: Phase 3
Enrollment: 2,336 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:2007-001451-19
Results first posted: 2012-10-17

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 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, 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 outcomes

Outcomes31

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 utilized.	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 utilized.	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 utilized.	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 utilized 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 utilized 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. The number of patients included in the calculation for each time point is noted as N. LOCF was not used in this analysis.	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 outcomes

Results by group608

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours	Placebo	-1.17	Standard Error 0.113	Incontinence episodes
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours	Mirabegron 50 mg	-1.57	Standard Error 0.113	Incontinence episodes
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours	Mirabegron 100 mg	-1.46	Standard Error 0.115	Incontinence episodes
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours	Tolterodine SR 4 mg	-1.27	Standard Error 0.112	Incontinence episodes
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours	Placebo	-1.34	Standard Error 0.110	micturitions
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours	Mirabegron 50 mg	-1.93	Standard Error 0.111	micturitions
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours	Mirabegron 100 mg	-1.77	Standard Error 0.110	micturitions
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours	Tolterodine SR 4 mg	-1.59	Standard Error 0.111	micturitions
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition	Placebo	12.3	Standard Error 1.99	mL
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition	Mirabegron 50 mg	24.2	Standard Error 2.01	mL

1 to 10 of 608Source ClinicalTrials.gov

See all 608 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	497
Overall Study	STARTED	Mirabegron 50 mg	497
Overall Study	STARTED	Mirabegron 100 mg	498
Overall Study	STARTED	Tolterodine SR 4 mg	495
Overall Study	Safety Analysis Set (SAF)	Placebo	494
Overall Study	Safety Analysis Set (SAF)	Mirabegron 50 mg	493
Overall Study	Safety Analysis Set (SAF)	Mirabegron 100 mg	496
Overall Study	Safety Analysis Set (SAF)	Tolterodine SR 4 mg	495
Overall Study	Full Analysis Set (FAS)	Placebo	480
Overall Study	Full Analysis Set (FAS)	Mirabegron 50 mg	473

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events212

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
other	hypertension	Vascular disorders	Placebo	38	494
other	hypertension	Vascular disorders	Mirabegron 50 mg	29	493
other	hypertension	Vascular disorders	Mirabegron 100 mg	27	496
other	hypertension	Vascular disorders	Tolterodine SR 4 mg	39	495
other	Dry mouth	Gastrointestinal disorders	Placebo	13	494
other	Dry mouth	Gastrointestinal disorders	Mirabegron 50 mg	14	493
other	Dry mouth	Gastrointestinal disorders	Mirabegron 100 mg	14	496
other	Dry mouth	Gastrointestinal disorders	Tolterodine SR 4 mg	50	495
serious	Erysipelas	Infections and infestations	Placebo	0	494
serious	Erysipelas	Infections and infestations	Mirabegron 50 mg	0	493

1 to 10 of 212Source ClinicalTrials.gov

See all 212 adverse events

Adverse event totals12

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, all-cause mortality	Tolterodine SR 4 mg
Total, other adverse events	Placebo	49	494
Total, other adverse events	Mirabegron 50 mg	42	493
Total, other adverse events	Mirabegron 100 mg	41	496
Total, other adverse events	Tolterodine SR 4 mg	86	495
Total, serious adverse events	Placebo	8	494
Total, serious adverse events	Mirabegron 50 mg	14	493

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23182126	BACKGROUND	PubMed
24246044	DERIVED	PubMed
37160401	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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