Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) (NCT NCT02757768)
NCT ID: NCT02757768
Last Updated: 2024-11-12
Results Overview
Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.
COMPLETED
PHASE4
715 participants
Baseline and Week 12
2024-11-12
Participant Flow
The study enrolled male participants with overactive bladder (OAB) symptoms who were taking the alpha-blocker tamsulosin for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. Participants entered a 4-week open label tamsulosin hydrochloride 0.4 mg once daily (QD) run-in period prior to being randomized in a 1:1 ratio into the 12-week double-blind treatment period of either mirabegron or placebo once daily.
Participant milestones
| Measure |
Mirabegron
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
356
|
359
|
|
Overall Study
Treated
|
352
|
354
|
|
Overall Study
COMPLETED
|
323
|
331
|
|
Overall Study
NOT COMPLETED
|
33
|
28
|
Reasons for withdrawal
| Measure |
Mirabegron
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Overall Study
Randomized Never Received Study Drug
|
3
|
4
|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
2
|
9
|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
|
Overall Study
Miscellaneous
|
4
|
2
|
Baseline Characteristics
This baseline measure is based on the full analysis set (FAS), the FAS was defined as all randomized participants who took at least one dose of double-blind treatment after randomization, reported at least one micturition in the baseline diary and at least one micturition post-baseline.
Baseline characteristics by cohort
| Measure |
Mirabegron
n=356 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=359 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
Total
n=715 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
65 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
65 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=5 Participants
|
359 Participants
n=7 Participants
|
715 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
339 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
332 Participants
n=5 Participants
|
325 Participants
n=7 Participants
|
657 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
16 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
MISSING/UNKNOWN
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Geographic Region
Europe
|
257 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Geographic Region
North America
|
99 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Micturition Episodes per 24 Hours
|
10.7 micturitions in 24 hours (M24MIC)
STANDARD_DEVIATION 2.5 • n=5 Participants • This baseline measure is based on the full analysis set (FAS), the FAS was defined as all randomized participants who took at least one dose of double-blind treatment after randomization, reported at least one micturition in the baseline diary and at least one micturition post-baseline.
|
10.7 micturitions in 24 hours (M24MIC)
STANDARD_DEVIATION 2.6 • n=7 Participants • This baseline measure is based on the full analysis set (FAS), the FAS was defined as all randomized participants who took at least one dose of double-blind treatment after randomization, reported at least one micturition in the baseline diary and at least one micturition post-baseline.
|
10.7 micturitions in 24 hours (M24MIC)
STANDARD_DEVIATION 2.6 • n=5 Participants • This baseline measure is based on the full analysis set (FAS), the FAS was defined as all randomized participants who took at least one dose of double-blind treatment after randomization, reported at least one micturition in the baseline diary and at least one micturition post-baseline.
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of double-blind study drug, reported at least 1 baseline micturition recorded in the 3-day e-diary and at least 1 postbaseline micturition. Last observation carried forward (LOCF) was used for missing values in the EoT.
Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day
|
-2.00 micturitions per day
Standard Error 0.13
|
-1.62 micturitions per day
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS.
Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day
Week 4
|
-1.42 micturitions per day
Standard Error 0.13
|
-1.32 micturitions per day
Standard Error 0.13
|
|
Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day
Week 8
|
-1.89 micturitions per day
Standard Error 0.13
|
-1.38 micturitions per day
Standard Error 0.13
|
|
Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day
Week 12
|
-1.95 micturitions per day
Standard Error 0.13
|
-1.56 micturitions per day
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The mean volume voided per micturition during 3 days of the 3-day micturition diary period.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
EoT
|
25.57 mL per micturition
Standard Error 2.42
|
16.32 mL per micturition
Standard Error 2.42
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
Week 4
|
17.74 mL per micturition
Standard Error 1.98
|
13.87 mL per micturition
Standard Error 1.98
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
Week 8
|
22.56 mL per micturition
Standard Error 2.31
|
16.28 mL per micturition
Standard Error 2.32
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
Week 12
|
26.31 mL per micturition
Standard Error 2.53
|
17.32 mL per micturition
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the full analysis set - incontinence (FAS-I), which consisted of all randomized participants who took at least 1 dose of double-blind study drug and reported 1 micturition at baseline and postbaseline in the 3-day e-diary. Missing values in the EoT were imputed using the LOCF method.
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.
Outcome measures
| Measure |
Mirabegron
n=132 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=129 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
Week 4
|
-0.97 incontinence episodes per day
Standard Error 0.18
|
-0.84 incontinence episodes per day
Standard Error 0.18
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
Week 8
|
-1.29 incontinence episodes per day
Standard Error 0.22
|
-1.20 incontinence episodes per day
Standard Error 0.23
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
Week 12
|
-1.48 incontinence episodes per day
Standard Error 0.22
|
-1.23 incontinence episodes per day
Standard Error 0.23
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
EoT
|
-1.45 incontinence episodes per day
Standard Error 0.21
|
-1.15 incontinence episodes per day
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is 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 Patient Perception of Intensity of Urgency Scale (PPIUS), where 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. 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
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
Week 4
|
-1.79 urgency episodes per day
Standard Error 0.15
|
-1.53 urgency episodes per day
Standard Error 0.15
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
Week 8
|
-2.68 urgency episodes per day
Standard Error 0.17
|
-1.97 urgency episodes per day
Standard Error 0.17
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
Week 12
|
-2.86 urgency episodes per day
Standard Error 0.17
|
-2.21 urgency episodes per day
Standard Error 0.17
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
EoT
|
-2.90 urgency episodes per day
Standard Error 0.17
|
-2.24 urgency episodes per day
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The IPSS total score classification ranges from mild (0 to 7) to moderate (8 to 19) or severe (20 to 35). Higher IPSS scored indicated more severe symptoms.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
Week 4
|
-3.9 units on a scale
Standard Error 0.3
|
-4.0 units on a scale
Standard Error 0.3
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
EoT
|
-5.7 units on a scale
Standard Error 0.3
|
-5.6 units on a scale
Standard Error 0.3
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
Week 8
|
-5.0 units on a scale
Standard Error 0.3
|
-5.2 units on a scale
Standard Error 0.3
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
Week 12
|
-5.9 units on a scale
Standard Error 0.3
|
-5.5 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). The lowest and highest possible scores range from 0 to 20 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
Week 4
|
-1.7 units on a scale
Standard Error 0.2
|
-2.1 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
Week 8
|
-2.2 units on a scale
Standard Error 0.2
|
-2.5 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
Week 12
|
-2.5 units on a scale
Standard Error 0.2
|
-2.5 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
EoT
|
-2.5 units on a scale
Standard Error 0.2
|
-2.6 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). The lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
EoT
|
-3.3 units on a scale
Standard Error 0.2
|
-3.0 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
Week 4
|
-2.2 units on a scale
Standard Error 0.1
|
-1.9 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
Week 8
|
-2.8 units on a scale
Standard Error 0.2
|
-2.6 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
Week 12
|
-3.3 units on a scale
Standard Error 0.2
|
-3.0 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
Week 8
|
-1.3 units on a scale
Standard Error 0.1
|
-1.1 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
Week 12
|
-1.5 units on a scale
Standard Error 0.1
|
-1.3 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
EoT
|
-1.4 units on a scale
Standard Error 0.1
|
-1.3 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
Week 4
|
-0.9 units on a scale
Standard Error 0.1
|
-0.7 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: The analysis population was the FAS-I. Missing values in the EoT were imputed using the LOCF method.
Urgency Incontinence was defined as the complaint of involuntary leakage accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.
Outcome measures
| Measure |
Mirabegron
n=132 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=129 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
Week 4
|
-0.97 urgency incontinence episodes per day
Standard Error 0.18
|
-0.85 urgency incontinence episodes per day
Standard Error 0.18
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
Week 8
|
-1.29 urgency incontinence episodes per day
Standard Error 0.22
|
-1.19 urgency incontinence episodes per day
Standard Error 0.23
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
Week 12
|
-1.52 urgency incontinence episodes per day
Standard Error 0.22
|
-1.24 urgency incontinence episodes per day
Standard Error 0.22
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
EoT
|
-1.49 urgency incontinence episodes per day
Standard Error 0.21
|
-1.16 urgency incontinence episodes per day
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
Overactive bladder symptoms were assessed using the Symptom Bother Scale of the Overactive Bladder questionnaire (OAB-q). The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). Lower scores on OAB-q symptom bother indicate a better response.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
Week 4
|
-13.73 units on a scale
Standard Error 0.91
|
-11.98 units on a scale
Standard Error 0.92
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
Week 8
|
-18.72 units on a scale
Standard Error 1.00
|
-14.88 units on a scale
Standard Error 0.99
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
Week 12
|
-20.93 units on a scale
Standard Error 1.07
|
-18.03 units on a scale
Standard Error 1.06
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
EoT
|
-20.18 units on a scale
Standard Error 1.04
|
-18.07 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A higher score on OAB-q HRQL indicated a better response.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score
Week 4
|
9.08 units on a scale
Standard Error 0.80
|
10.43 units on a scale
Standard Error 0.80
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score
Week 8
|
13.06 units on a scale
Standard Error 0.85
|
13.53 units on a scale
Standard Error 0.85
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score
Week 12
|
15.90 units on a scale
Standard Error 0.91
|
15.00 units on a scale
Standard Error 0.90
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score
EoT
|
15.07 units on a scale
Standard Error 0.89
|
15.12 units on a scale
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Coping subscale ranges from 8 to 48. The Coping score was calculated by adding the 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
EoT
|
18.05 units on a scale
Standard Error 1.07
|
18.02 units on a scale
Standard Error 1.07
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
Week 4
|
10.58 units on a scale
Standard Error 0.96
|
12.47 units on a scale
Standard Error 0.97
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
Week 8
|
16.01 units on a scale
Standard Error 1.00
|
15.25 units on a scale
Standard Error 1.00
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
Week 12
|
18.93 units on a scale
Standard Error 1.09
|
18.03 units on a scale
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Concern subscale ranges from 7 to 42. The Concern score was calculated by adding the 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
Week 4
|
9.06 units on a scale
Standard Error 0.91
|
10.87 units on a scale
Standard Error 0.92
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
EoT
|
14.81 units on a scale
Standard Error 0.98
|
14.67 units on a scale
Standard Error 0.99
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
Week 8
|
13.34 units on a scale
Standard Error 0.98
|
12.99 units on a scale
Standard Error 0.98
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
Week 12
|
15.64 units on a scale
Standard Error 1.00
|
14.47 units on a scale
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Sleep subscale ranges from 5 to 30. The Sleep score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
EoT
|
16.87 units on a scale
Standard Error 1.13
|
16.62 units on a scale
Standard Error 1.13
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
Week 4
|
10.43 units on a scale
Standard Error 1.05
|
10.45 units on a scale
Standard Error 1.06
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
Week 8
|
15.32 units on a scale
Standard Error 1.10
|
14.41 units on a scale
Standard Error 1.09
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
Week 12
|
17.94 units on a scale
Standard Error 1.15
|
16.41 units on a scale
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Social Interaction subscale ranges from 5 to 30. The Social Interaction score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
Week 4
|
5.55 units on a scale
Standard Error 0.74
|
6.65 units on a scale
Standard Error 0.74
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
Week 12
|
9.48 units on a scale
Standard Error 0.79
|
9.57 units on a scale
Standard Error 0.79
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
Week 8
|
8.03 units on a scale
Standard Error 0.79
|
8.35 units on a scale
Standard Error 0.79
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
EoT
|
8.96 units on a scale
Standard Error 0.77
|
9.67 units on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS.
The EQ-5D-5L is an international standardized non-disease specific generic instrument for describing and valuing health status. It has a multidimensional measure of health-related QoL, capable of being expressed as a single index value and specifically designed to complement other health status measures. The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels (e.g., 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the activity). Health-state utility (HSU) data are estimates of the preference for a given state of health on a cardinal numeric scale, where a value of 1.0 represents full health, 0.0 represents dead, and negative values represent states worse than death. Missing EoT values were imputed using LOCF method.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
Week 4
|
0.011 units on a scale
Standard Error 0.009
|
0.019 units on a scale
Standard Error 0.008
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
Week 8
|
0.019 units on a scale
Standard Error 0.009
|
0.030 units on a scale
Standard Error 0.009
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
Week 12
|
0.028 units on a scale
Standard Error 0.009
|
0.032 units on a scale
Standard Error 0.008
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
EoT
|
0.026 units on a scale
Standard Error 0.009
|
0.034 units on a scale
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.
The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
Week 4
|
-0.6 units on a scale
Standard Error 0.1
|
-0.5 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
Week 8
|
-0.8 units on a scale
Standard Error 0.1
|
-0.7 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
EoT
|
-0.9 units on a scale
Standard Error 0.1
|
-0.9 units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
Week 12
|
-1.0 units on a scale
Standard Error 0.1
|
-0.9 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: The analysis population was the FAS.
The TUFS was calculated by adding the PPIUS scores of every void in a participant's 3-day diary, and dividing this by the number of days recorded in the diary. Due to a programming failure in the e-diary data for the number of pads used was not collected.
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)
|
NA units on a scale
Standard Error NA
Due to a programming failure in the e-diary data for the number of pads used was not collected.
|
NA units on a scale
Standard Error NA
Due to a programming failure in the e-diary data for the number of pads used was not collected.
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population was the full analysis set - nocturia (FAS-N), which consisted of all randomized participants who took at least 1 dose of double-blind study drug and reported 1 micturition at baseline and postbaseline in the 3-day e-diary.
A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence is not considered a nocturia episode. The mean number of nocturia episodes per day (24 hours) was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.
Outcome measures
| Measure |
Mirabegron
n=142 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=124 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Week 4
|
-0.32 nocturia episodes per 24 hours
Standard Error 0.07
|
-0.45 nocturia episodes per 24 hours
Standard Error 0.08
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Week 12
|
-0.51 nocturia episodes per 24 hours
Standard Error 0.08
|
-0.52 nocturia episodes per 24 hours
Standard Error 0.08
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
EoT
|
-0.49 nocturia episodes per 24 hours
Standard Error 0.07
|
-0.52 nocturia episodes per 24 hours
Standard Error 0.08
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Week 8
|
-0.48 nocturia episodes per 24 hours
Standard Error 0.07
|
-0.55 nocturia episodes per 24 hours
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: The analysis population consisted of the FAS. LOCF was used for EOT.
The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).
Outcome measures
| Measure |
Mirabegron
n=337 Participants
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=339 Participants
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
Week 12
|
19.1 units on a scale
Standard Error 1.5
|
16.9 units on a scale
Standard Error 1.5
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
EoT
|
18.4 units on a scale
Standard Error 1.5
|
16.9 units on a scale
Standard Error 1.5
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
Week 4
|
15.6 units on a scale
Standard Error 1.3
|
12.5 units on a scale
Standard Error 1.4
|
|
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
Week 8
|
18.6 units on a scale
Standard Error 1.4
|
16.1 units on a scale
Standard Error 1.4
|
Adverse Events
Mirabegron
Placebo
Serious adverse events
| Measure |
Mirabegron
n=352 participants at risk
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=354 participants at risk
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Cardiac disorders
Chronotropic incompetence
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
General disorders
Peripheral swelling
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Infections and infestations
Neuroborreliosis
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Infections and infestations
Urosepsis
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/352 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.00%
0/354 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/352 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
0.28%
1/354 • Number of events 1 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
Other adverse events
| Measure |
Mirabegron
n=352 participants at risk
Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
|
Placebo
n=354 participants at risk
Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
|
|---|---|---|
|
Nervous system disorders
Headache
|
1.7%
6/352 • Number of events 6 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
2.3%
8/354 • Number of events 9 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
|
Vascular disorders
Hypertension
|
1.7%
6/352 • Number of events 6 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
3.1%
11/354 • Number of events 12 • From first double-blind medication intake until 30 days after last double-blind medication intake; 16 weeks
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
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