Trial Outcomes & Findings for A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder (NCT NCT04562090)
NCT ID: NCT04562090
Last Updated: 2024-11-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
249 participants
Primary outcome timeframe
Baseline, week 12
Results posted on
2024-11-15
Participant Flow
Participants were enrolled at study sites in China.
Participants with symptoms of overactive bladder (OAB) for at least 12 weeks before initiation of the screening period and who met all of the inclusion and none of the exclusion criteria were enrolled in this study.
Participant milestones
| Measure |
Mirabegron 25 mg
Participants received single oral dose of mirabegron 25 milligrams (mg) tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator.
|
Mirabegron 50 mg
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
165
|
|
Overall Study
Participants (Never-Up Titrated)
|
44
|
0
|
|
Overall Study
Participants (Up Titrated to 50 mg)
|
39
|
0
|
|
Overall Study
Treated
|
83
|
165
|
|
Overall Study
COMPLETED
|
78
|
153
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
| Measure |
Mirabegron 25 mg
Participants received single oral dose of mirabegron 25 milligrams (mg) tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator.
|
Mirabegron 50 mg
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Miscellaneous
|
0
|
3
|
Baseline Characteristics
Full Analysis Set 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.
Baseline characteristics by cohort
| Measure |
Mirabegron 25 mg
n=84 Participants
Participants received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator.
|
Mirabegron 50 mg
n=165 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 16 • n=84 Participants
|
50.6 Years
STANDARD_DEVIATION 14.6 • n=165 Participants
|
49.7 Years
STANDARD_DEVIATION 15.1 • n=249 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=84 Participants
|
120 Participants
n=165 Participants
|
185 Participants
n=249 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=84 Participants
|
45 Participants
n=165 Participants
|
64 Participants
n=249 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=84 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=249 Participants
|
|
Race (NIH/OMB)
Asian
|
84 Participants
n=84 Participants
|
165 Participants
n=165 Participants
|
249 Participants
n=249 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=84 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=249 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=84 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=249 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=84 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=249 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=84 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=249 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=84 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=249 Participants
|
|
Race/Ethnicity, Customized
Chinese Ethnicity
|
84 Participants
n=84 Participants
|
165 Participants
n=165 Participants
|
249 Participants
n=249 Participants
|
|
Mean Number of Micturitions per 24 hours
|
11.8 micturitions per 24 hours
STANDARD_DEVIATION 6.36 • n=79 Participants • Full Analysis Set 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.
|
11.77 micturitions per 24 hours
STANDARD_DEVIATION 5.47 • n=165 Participants • Full Analysis Set 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.
|
11.78 micturitions per 24 hours
STANDARD_DEVIATION 5.76 • n=244 Participants • Full Analysis Set 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.
|
PRIMARY outcome
Timeframe: Baseline, week 12Population: 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.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=147 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group
|
-3.76 micturitions per 24 hours
Standard Deviation 0.40
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after last dose (up to week 16)Population: Safety Analysis Set (SAF) consisted of all participants who took at least 1 dose of IP.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=83 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=165 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
18 participants
|
58 participants
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: SAF population with available data at specified time point.
PVR was assessed by ultrasonography.
Outcome measures
| Measure |
Mirabegron 50 mg
n=34 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=144 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Post Void Residual (PVR) Volume
|
-2.7 milliliter
Standard Deviation 26.3
|
-1.3 milliliter
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, and 12Population: FAS population with available data at specified time point.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=77 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=159 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
Change at Week 4
|
-2.09 urgency episodes per 24 hours
Standard Deviation 2.35
|
-2.53 urgency episodes per 24 hours
Standard Deviation 5.54
|
|
Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
Change at Week 8
|
-2.66 urgency episodes per 24 hours
Standard Deviation 2.57
|
-2.98 urgency episodes per 24 hours
Standard Deviation 5.78
|
|
Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
Change at Week 12
|
-2.57 urgency episodes per 24 hours
Standard Deviation 1.92
|
-3.55 urgency episodes per 24 hours
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, and 12Population: FAS population with available data at specified time point.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=77 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=159 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Change at Week 4
|
-0.48 incontinence episodes per 24 hours
Standard Deviation 1.82
|
-0.77 incontinence episodes per 24 hours
Standard Deviation 2.47
|
|
Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Change at Week 8
|
-1.06 incontinence episodes per 24 hours
Standard Deviation 1.85
|
-0.89 incontinence episodes per 24 hours
Standard Deviation 2.59
|
|
Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Change at Week 12
|
-1.03 incontinence episodes per 24 hours
Standard Deviation 1.77
|
-0.97 incontinence episodes per 24 hours
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, and 12Population: FAS population with available data at specified time point.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=77 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=159 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Change at Week 4
|
-0.37 incontinence episodes per 24 hours
Standard Deviation 1.11
|
-0.47 incontinence episodes per 24 hours
Standard Deviation 3.06
|
|
Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Change at Week 8
|
-0.67 incontinence episodes per 24 hours
Standard Deviation 1.50
|
-0.45 incontinence episodes per 24 hours
Standard Deviation 3.05
|
|
Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Change at Week 12
|
-0.42 incontinence episodes per 24 hours
Standard Deviation 0.91
|
-0.54 incontinence episodes per 24 hours
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, and 12Population: FAS population with available data at specified time point.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=77 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=159 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
Change at Week 4
|
-0.67 urge incontinence episodes per 24 hours
Standard Deviation 1.71
|
-1.18 urge incontinence episodes per 24 hours
Standard Deviation 5.02
|
|
Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
Change at Week 8
|
-1.15 urge incontinence episodes per 24 hours
Standard Deviation 2.38
|
-1.25 urge incontinence episodes per 24 hours
Standard Deviation 5.06
|
|
Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
Change at Week 12
|
-0.92 urge incontinence episodes per 24 hours
Standard Deviation 1.71
|
-1.36 urge incontinence episodes per 24 hours
Standard Deviation 5.23
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, and 12Population: FAS population with available data at specified time point.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=80 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=155 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline in OAB Symptom Score (OABSS)
Change at Week 4
|
-2.91 scores on a scale
Standard Deviation 2.85
|
-3.01 scores on a scale
Standard Deviation 2.85
|
|
Change From Baseline in OAB Symptom Score (OABSS)
Change at Week 8
|
-5.34 scores on a scale
Standard Deviation 2.69
|
-4.29 scores on a scale
Standard Deviation 3.01
|
|
Change From Baseline in OAB Symptom Score (OABSS)
Change at Week 12
|
-6.19 scores on a scale
Standard Deviation 2.72
|
-5.43 scores on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Baseline and weeks 4 and 8Population: FAS population with available data at specified time point.
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.
Outcome measures
| Measure |
Mirabegron 50 mg
n=77 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
Mirabegron 50 mg
n=159 Participants
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Number of Micturition Per 24 Hours
Change at Week 4
|
-2.06 micturitions per 24 hours
Standard Deviation 2.64
|
-2.44 micturitions per 24 hours
Standard Deviation 4.62
|
|
Change From Baseline in Mean Number of Micturition Per 24 Hours
Change at Week 8
|
-2.65 micturitions per 24 hours
Standard Deviation 2.55
|
-3.01 micturitions per 24 hours
Standard Deviation 4.76
|
Adverse Events
Mirabegron 25 mg (Never Up-titrated)
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Mirabegron 25 mg (Later Up-titrated to 50 mg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Mirabegron 50 mg (Up-titrated From 25 mg)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Mirabegron 50 mg
Serious events: 8 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirabegron 25 mg (Never Up-titrated)
n=44 participants at risk
Participants who received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal for a duration of 12 weeks and were never up-titrated to receive Mirabegron 50 mg.
|
Mirabegron 25 mg (Later Up-titrated to 50 mg)
n=39 participants at risk
Participants received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal until week 4 or 8 and were up-titrated to receive Mirabegron 50 mg until week 12.
|
Mirabegron 50 mg (Up-titrated From 25 mg)
n=39 participants at risk
Participants who were up-titrated from mirabegron 25 mg received single oral dose of Mirabegron 50 mg tablet once daily, at the same time after a meal from week 4 or 8 until week 12.
|
Mirabegron 50 mg
n=165 participants at risk
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/165 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
General disorders
Chest discomfort
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
2.3%
1/44 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/165 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/165 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/44 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.61%
1/165 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Surgical and medical procedures
Abortion induced
|
2.3%
1/44 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/165 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/165 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
Other adverse events
| Measure |
Mirabegron 25 mg (Never Up-titrated)
n=44 participants at risk
Participants who received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal for a duration of 12 weeks and were never up-titrated to receive Mirabegron 50 mg.
|
Mirabegron 25 mg (Later Up-titrated to 50 mg)
n=39 participants at risk
Participants received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal until week 4 or 8 and were up-titrated to receive Mirabegron 50 mg until week 12.
|
Mirabegron 50 mg (Up-titrated From 25 mg)
n=39 participants at risk
Participants who were up-titrated from mirabegron 25 mg received single oral dose of Mirabegron 50 mg tablet once daily, at the same time after a meal from week 4 or 8 until week 12.
|
Mirabegron 50 mg
n=165 participants at risk
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/44 • Number of events 1 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
0.00%
0/39 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
3.6%
6/165 • Number of events 6 • From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
|
Additional Information
Clinical Transparency
Astellas Pharma China, Inc.
Phone: +86-(0)10-85216666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER