Trial · NCT04562090
A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder
NCT04562090, Phase 4, Completed, Astellas Pharma China, Inc.; results first posted 2023-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder. Trials, record NCT04562090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04562090
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder
- NCT number
- NCT04562090
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 249 participants, actual
- Lead sponsor
- Astellas Pharma China, Inc.
- Conditions
- Urge Incontinence, Overactive Bladder (OAB)
- Interventions
- mirabegron
- First posted
- 2020-09-24
- Last updated
- 2024-11-15
- Results first posted
- 2023-03-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group | Baseline, week 12 | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | From first dose up to 30 days after last dose (up to week 16) | AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug. |
| Secondary | Change From Baseline to Week 12 in Post Void Residual (PVR) Volume | Baseline, week 12 | PVR was assessed by ultrasonography. |
| Secondary | Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which was difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where grade 0 = No urgency; grade 1 = Mild urgency; grade 2 = Moderate urgency, could delay voiding a short while; grade 3 = Severe urgency, could not delay voiding; grade 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. |
| Secondary | Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | An incontinence episode was defined as an episode with any involuntary loss of urine. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. |
| Secondary | Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | An incontinence episode was defined as an episode with any involuntary loss of urine. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. |
| Secondary | Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | An incontinence episode was defined as an episode with any involuntary loss of urine. The mean number of urge incontinence episodes per 24 hours was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. |
| Secondary | Change From Baseline in OAB Symptom Score (OABSS) | Baseline and weeks 4, 8, and 12 | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms: Daytime Frequency ("How many times do you typically urinate from waking in the morning until sleeping at night?" where scores range from 0-2), Nighttime Frequency ("How many times do you typically wake up to urinate from sleeping at night until waking in the morning?" where scores range from 0-3), Urgency ("How often do you have a sudden desire to urinate, which is difficult to defer?" where scores range from 0-5), Urgency Incontinence ("How often do you leak urine because you cannot defer the sudden desire to urinate?" where scores range from 0-5). The total score ranges from 0 to 15 with higher score indicating more symptoms. |
| Secondary | Change From Baseline in Mean Number of Micturition Per 24 Hours | Baseline and weeks 4 and 8 | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group | Baseline, week 12 | Full Analysis set (FAS) included all participants who were randomized and received at least 1 dose of investigational product (IP) and had at least 1 post baseline measurement for mean number of micturitions per 24 hours. Participants with available data were analyzed. | micturitions per 24 hours | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | From first dose up to 30 days after last dose (up to week 16) | Safety Analysis Set (SAF) consisted of all participants who took at least 1 dose of IP. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in Post Void Residual (PVR) Volume | Baseline, week 12 | SAF population with available data at specified time point. | milliliter | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | FAS population with available data at specified time point. | urgency episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | FAS population with available data at specified time point. | incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | FAS population with available data at specified time point. | incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, and 12 | FAS population with available data at specified time point. | urge incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline in OAB Symptom Score (OABSS) | Baseline and weeks 4, 8, and 12 | FAS population with available data at specified time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturition Per 24 Hours | Baseline and weeks 4 and 8 | FAS population with available data at specified time point. | micturitions per 24 hours | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group | Mirabegron 50 mg | -3.76 | Standard Deviation 0.40 | micturitions per 24 hours | |
| Number of Participants With Treatment Emergent Adverse Events | Mirabegron 25 mg | 18 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events | Mirabegron 50 mg | 58 | participants | ||
| Change From Baseline to Week 12 in Post Void Residual (PVR) Volume | Mirabegron 25 mg | -2.7 | Standard Deviation 26.3 | milliliter | |
| Change From Baseline to Week 12 in Post Void Residual (PVR) Volume | Mirabegron 50 mg | -1.3 | Standard Deviation 24.5 | milliliter | |
| Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Mirabegron 25 mg | Change at Week 4 | -2.09 | Standard Deviation 2.35 | urgency episodes per 24 hours |
| Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Mirabegron 50 mg | Change at Week 4 | -2.53 | Standard Deviation 5.54 | urgency episodes per 24 hours |
| Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Mirabegron 25 mg | Change at Week 8 | -2.66 | Standard Deviation 2.57 | urgency episodes per 24 hours |
| Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Mirabegron 50 mg | Change at Week 8 | -2.98 | Standard Deviation 5.78 | urgency episodes per 24 hours |
| Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Mirabegron 25 mg | Change at Week 12 | -2.57 | Standard Deviation 1.92 | urgency episodes per 24 hours |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron 25 mg | 84 | |
| Overall Study | STARTED | Mirabegron 50 mg | 165 | |
| Overall Study | Participants (Never-Up Titrated) | Mirabegron 25 mg | 44 | |
| Overall Study | Participants (Never-Up Titrated) | Mirabegron 50 mg | 0 | |
| Overall Study | Participants (Up Titrated to 50 mg) | Mirabegron 25 mg | 39 | |
| Overall Study | Participants (Up Titrated to 50 mg) | Mirabegron 50 mg | 0 | |
| Overall Study | Treated | Mirabegron 25 mg | 83 | |
| Overall Study | Treated | Mirabegron 50 mg | 165 | |
| Overall Study | COMPLETED | Mirabegron 25 mg | 78 | |
| Overall Study | COMPLETED | Mirabegron 50 mg | 153 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
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 | Urinary tract infection | Infections and infestations | Mirabegron 25 mg (Never Up-titrated) | 1 | 44 | 1 |
| other | Urinary tract infection | Infections and infestations | Mirabegron 25 mg (Later Up-titrated to 50 mg) | 0 | 39 | 0 |
| other | Urinary tract infection | Infections and infestations | Mirabegron 50 mg (Up-titrated From 25 mg) | 3 | 39 | 3 |
| other | Urinary tract infection | Infections and infestations | Mirabegron 50 mg | 6 | 165 | 6 |
| serious | Myocardial ischaemia | Cardiac disorders | Mirabegron 25 mg (Never Up-titrated) | 0 | 44 | 0 |
| serious | Myocardial ischaemia | Cardiac disorders | Mirabegron 25 mg (Later Up-titrated to 50 mg) | 0 | 39 | 0 |
| serious | Myocardial ischaemia | Cardiac disorders | Mirabegron 50 mg (Up-titrated From 25 mg) | 1 | 39 | 1 |
| serious | Myocardial ischaemia | Cardiac disorders | Mirabegron 50 mg | 0 | 165 | 0 |
| serious | Abdominal discomfort | Gastrointestinal disorders | Mirabegron 25 mg (Never Up-titrated) | 0 | 44 | 0 |
| serious | Abdominal discomfort | Gastrointestinal disorders | Mirabegron 25 mg (Later Up-titrated to 50 mg) | 0 | 39 | 0 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron 25 mg (Never Up-titrated) | 0 | 44 |
| Total, all-cause mortality | Mirabegron 25 mg (Later Up-titrated to 50 mg) | 0 | 39 |
| Total, all-cause mortality | Mirabegron 50 mg (Up-titrated From 25 mg) | 0 | 39 |
| Total, all-cause mortality | Mirabegron 50 mg | 0 | 165 |
| Total, other adverse events | Mirabegron 25 mg (Never Up-titrated) | 1 | 44 |
| Total, other adverse events | Mirabegron 25 mg (Later Up-titrated to 50 mg) | 0 | 39 |
| Total, other adverse events | Mirabegron 50 mg (Up-titrated From 25 mg) | 3 | 39 |
| Total, other adverse events | Mirabegron 50 mg | 6 | 165 |
| Total, serious adverse events | Mirabegron 25 mg (Never Up-titrated) | 3 | 44 |
| Total, serious adverse events | Mirabegron 25 mg (Later Up-titrated to 50 mg) | 1 | 39 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mirabegron 25 mg vs Mirabegron 50 mg: Number of Participants With Treatment Emergent Adverse Events |
Source 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/NCT04562090
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