A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01745094
Collaborator
(none)
223
5
1
9.7
44.6
4.6
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.
Study Design
Study Type:
Interventional
Actual Enrollment
:
223 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan
Actual Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Jul 23, 2013
Actual Study Completion Date
:
Jul 23, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Concomitant Group concomitant administration of mirabegron to solifenacin treated patients |
Drug: mirabegron
oral
Other Names:
Drug: solifenacin
oral
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [From first dose of study drug up to weeks 16]
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.
Secondary Outcome Measures
- Change From Baseline in OABSS Total Score [Baseline and week 8, 16]
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.
- Number of Participants Who Achieved Normalization for OABSS Total Score [Week 8 and 16]
Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.
- Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score [Baseline and week 8, 16]
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.
- Change From Baseline in OAB-q SF Total HRQL Score [Baseline and week 8, 16]
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.
- Change From Baseline in the Number of Micturitions Per 24 Hours [Baseline and week 4, 8, 12, 16]
Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded.
- Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours [Week 16]
Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours.
- Change From Baseline in the Number of Urgency Episodes Per 24 Hours [Baseline and week 4, 8, 12, 16]
Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis.
- Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours [Week 16]
Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.
- Change From Baseline in the Number of Incontinence Episodes Per 24 Hours [Baseline and week 4, 8, 12, 16]
Participants completed the patient diary (paper document) for 3 days immediately before each visit. 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 by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis.
- Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours [Week 16]
Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.
- Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours [Baseline and week 4, 8, 12, 16]
Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis.
- Change From Baseline in the Volume Voided Per Micturition [Baseline and week 8, 16]
Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis.
- Change From Baseline in the Number of Nocturia Episodes Per Night [Baseline and week 4, 8, 12, 16]
Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis.
- Change From Baseline in Postvoid Residual (PVR) Volume [Baseline and week 4, 8, 12, 16]
Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Female: postmenopausal OAB outpatient
-
Male: OAB outpatient who did not wish to have children at all
-
Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
-
Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points
Exclusion Criteria:
-
Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
-
Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
-
Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chubu | Japan | |||
| 2 | Hokkaido | Japan | |||
| 3 | Kansai | Japan | |||
| 4 | Kantou | Japan | |||
| 5 | Kyushu | Japan |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Director: Medical Director, Astellas Pharma Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01745094
Other Study ID Numbers:
- 178-CL-110
First Posted:
Dec 7, 2012
Last Update Posted:
Feb 28, 2018
Last Verified:
Dec 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Astellas Pharma Inc
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants with overactive bladder (OAB) were enrolled in 29 sites in Japan. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Period Title: Overall Study | ||||
| STARTED | 35 | 37 | 58 | 93 |
| COMPLETED | 30 | 37 | 46 | 90 |
| NOT COMPLETED | 5 | 0 | 12 | 3 |
Baseline Characteristics
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. | Total of all reporting groups |
| Overall Participants | 35 | 37 | 58 | 93 | 223 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
65.6
(8.71)
|
62.8
(10.27)
|
66.9
(9.47)
|
63.8
(10.34)
|
64.7
(9.92)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
30
85.7%
|
32
86.5%
|
45
77.6%
|
79
84.9%
|
186
83.4%
|
| Male |
5
14.3%
|
5
13.5%
|
13
22.4%
|
14
15.1%
|
37
16.6%
|
| Overactive Bladder Symptom Score (OABSS) (Units on a Scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Units on a Scale] |
7.1
(2.31)
|
8.5
(2.36)
|
7.5
(2.67)
|
8.1
(2.45)
|
7.8
(2.49)
|
| Overactive Bladder questionnaire Short Form (OAB-q SF) Score: Symptom Severity (Units on a Scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Units on a Scale] |
33.94
(20.386)
|
39.37
(20.470)
|
32.12
(17.701)
|
31.29
(19.205)
|
33.27
(19.328)
|
| OAB-q SF Score: Total Health-Related Quality of Life (HRQOL) (Units on a Scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Units on a Scale] |
73.71
(18.662)
|
70.31
(18.873)
|
75.10
(17.708)
|
76.06
(19.341)
|
74.49
(18.743)
|
| Number of Micturitions per 24 Hours (micturitions) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [micturitions] |
10.38
(2.128)
|
11.12
(2.722)
|
9.81
(1.918)
|
10.15
(2.331)
|
10.26
(2.302)
|
| Number of Urgency Episodes per 24 Hours (urgency episodes) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [urgency episodes] |
2.86
(2.433)
|
4.12
(2.586)
|
2.86
(1.997)
|
3.63
(2.846)
|
3.42
(2.586)
|
| Number of Incontinence Episodes per 24 Hours (incontinence episodes) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [incontinence episodes] |
1.45
(1.454)
|
1.54
(1.248)
|
2.09
(2.121)
|
1.51
(1.520)
|
1.64
(1.616)
|
| Number of Urge Incontinence Episodes per 24 Hours (urge incontinence episodes) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [urge incontinence episodes] |
1.42
(1.506)
|
1.42
(1.243)
|
1.69
(1.366)
|
1.30
(1.138)
|
1.43
(1.245)
|
| Volume Voided per Micturition (mL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mL] |
158.627
(47.0511)
|
158.633
(43.6678)
|
182.362
(56.3405)
|
173.658
(47.5973)
|
171.029
(49.7826)
|
| Number of Nocturia Episodes per Night (nocturia episodes) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [nocturia episodes] |
1.79
(1.075)
|
1.55
(0.783)
|
1.85
(1.006)
|
1.72
(1.084)
|
1.74
(1.018)
|
| Postvoid Residual (PVR) Volume (mL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mL] |
14.95
(23.214)
|
10.51
(16.066)
|
13.93
(17.188)
|
12.11
(20.199)
|
12.76
(19.273)
|
Outcome Measures
| Title | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. |
| Time Frame | From first dose of study drug up to weeks 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 35 | 37 | 58 | 93 |
| Any TEAEs |
23
65.7%
|
21
56.8%
|
42
72.4%
|
69
74.2%
|
| Mild |
22
62.9%
|
20
54.1%
|
40
69%
|
67
72%
|
| Moderate |
1
2.9%
|
1
2.7%
|
1
1.7%
|
2
2.2%
|
| Severe |
0
0%
|
0
0%
|
1
1.7%
|
0
0%
|
| Drug-related TEAEs |
6
17.1%
|
6
16.2%
|
12
20.7%
|
28
30.1%
|
| Deaths |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serious TEAEs |
1
2.9%
|
1
2.7%
|
5
8.6%
|
4
4.3%
|
| Drug-related Serious TEAEs |
0
0%
|
0
0%
|
1
1.7%
|
0
0%
|
| TEAEs leading to permanent discontinuation (PD) |
0
0%
|
0
0%
|
3
5.2%
|
1
1.1%
|
| Drug-related TEAEs leading to PD |
0
0%
|
0
0%
|
2
3.4%
|
1
1.1%
|
| Title | Change From Baseline in OABSS Total Score |
|---|---|
| Description | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. |
| Time Frame | Baseline and week 8, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Week 8 |
-3.5
(2.32)
|
-2.1
(2.22)
|
-3.5
(2.52)
|
-2.5
(2.32)
|
| Week 16 |
-3.5
(2.60)
|
-3.9
(2.70)
|
-3.6
(2.90)
|
-4.0
(2.90)
|
| Week 16 (LOCF) |
-3.4
(2.95)
|
-3.9
(2.70)
|
-3.6
(2.86)
|
-4.0
(2.90)
|
| Title | Number of Participants Who Achieved Normalization for OABSS Total Score |
|---|---|
| Description | Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. |
| Time Frame | Week 8 and 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Week 8 |
19
54.3%
|
8
21.6%
|
28
48.3%
|
26
28%
|
| Week 16 |
18
51.4%
|
16
43.2%
|
27
46.6%
|
48
51.6%
|
| Week 16 (LOCF) |
19
54.3%
|
16
43.2%
|
29
50%
|
49
52.7%
|
| Title | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score |
|---|---|
| Description | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. |
| Time Frame | Baseline and week 8, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Week 8 |
-19.46
(16.735)
|
-12.52
(20.926)
|
-15.29
(14.348)
|
-10.39
(17.222)
|
| Week 16 |
-21.00
(19.557)
|
-22.25
(20.877)
|
-17.68
(15.930)
|
-16.56
(18.171)
|
| Week 16 (LOCF) |
-21.21
(18.631)
|
-22.25
(20.877)
|
-17.55
(16.253)
|
-16.31
(18.034)
|
| Title | Change From Baseline in OAB-q SF Total HRQL Score |
|---|---|
| Description | The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. |
| Time Frame | Baseline and week 8, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Week 8 |
15.14
(12.786)
|
9.31
(15.559)
|
12.43
(15.449)
|
6.14
(13.797)
|
| Week 16 |
17.54
(13.349)
|
16.72
(16.439)
|
14.72
(16.428)
|
12.72
(17.170)
|
| Week 16 (LOCF) |
17.34
(13.005)
|
16.72
(16.439)
|
13.88
(16.080)
|
12.56
(17.022)
|
| Title | Change From Baseline in the Number of Micturitions Per 24 Hours |
|---|---|
| Description | Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded. |
| Time Frame | Baseline and week 4, 8, 12, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Week 4 |
-0.34
(1.576)
|
-0.98
(1.977)
|
-1.33
(1.604)
|
-1.02
(1.666)
|
| Week 8 |
-1.69
(1.690)
|
-1.31
(1.862)
|
-1.74
(1.586)
|
-1.32
(1.656)
|
| Week 12 |
-1.98
(1.667)
|
-2.40
(1.997)
|
-1.50
(1.850)
|
-1.75
(2.136)
|
| Week 16 |
-2.06
(1.677)
|
-2.36
(2.106)
|
-1.90
(1.920)
|
-2.13
(2.118)
|
| Week 16 (LOCF) |
-1.89
(1.789)
|
-2.36
(2.106)
|
-1.94
(1.792)
|
-2.12
(2.094)
|
| Title | Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours |
|---|---|
| Description | Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Count of Participants [Participants] |
10
28.6%
|
17
45.9%
|
23
39.7%
|
40
43%
|
| Title | Change From Baseline in the Number of Urgency Episodes Per 24 Hours |
|---|---|
| Description | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis. |
| Time Frame | Baseline and week 4, 8, 12, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 30 | 36 | 49 | 90 |
| Week 4 |
-1.15
(1.843)
|
-1.26
(1.927)
|
-1.45
(1.790)
|
-1.43
(2.057)
|
| Week 8 |
-1.77
(0.969)
|
-1.49
(1.897)
|
-1.76
(1.490)
|
-1.37
(2.189)
|
| Week 12 |
-1.95
(1.279)
|
-2.55
(2.162)
|
-1.89
(1.674)
|
-1.88
(2.576)
|
| Week 16 |
-1.77
(1.253)
|
-2.59
(2.201)
|
-1.93
(1.759)
|
-2.06
(2.419)
|
| Week 16 (LOCF) |
-1.57
(1.382)
|
-2.59
(2.201)
|
-1.93
(1.877)
|
-2.02
(2.392)
|
| Title | Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours |
|---|---|
| Description | Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Count of Participants [Participants] |
16
45.7%
|
13
35.1%
|
31
53.4%
|
38
40.9%
|
| Title | Change From Baseline in the Number of Incontinence Episodes Per 24 Hours |
|---|---|
| Description | Participants completed the patient diary (paper document) for 3 days immediately before each visit. 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 by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis. |
| Time Frame | Baseline and week 4, 8, 12, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 14 | 28 | 29 | 60 |
| Week 4 |
-0.85
(0.675)
|
-0.55
(0.787)
|
-1.12
(1.141)
|
-0.64
(1.032)
|
| Week 8 |
-1.06
(0.983)
|
-0.73
(0.842)
|
-1.26
(1.453)
|
-0.76
(1.273)
|
| Week 12 |
-1.31
(1.236)
|
-1.04
(1.177)
|
-1.03
(1.238)
|
-0.93
(1.248)
|
| Week 16 |
-1.22
(1.076)
|
-1.08
(1.168)
|
-1.32
(1.517)
|
-1.08
(1.068)
|
| Week 16 (LOCF) |
-1.07
(1.064)
|
-1.08
(1.168)
|
-1.32
(1.505)
|
-1.06
(1.055)
|
| Title | Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours |
|---|---|
| Description | Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Count of Participants [Participants] |
10
28.6%
|
21
56.8%
|
19
32.8%
|
46
49.5%
|
| Title | Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours |
|---|---|
| Description | Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis. |
| Time Frame | Baseline and week 4, 8, 12, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 11 | 28 | 26 | 52 |
| Week 4 |
-0.87
(0.689)
|
-0.50
(0.756)
|
-0.77
(1.220)
|
-0.82
(1.055)
|
| Week 8 |
-1.17
(1.045)
|
-0.65
(0.793)
|
-1.07
(1.068)
|
-0.72
(1.208)
|
| Week 12 |
-1.30
(1.252)
|
-0.94
(1.115)
|
-0.84
(0.996)
|
-0.91
(1.160)
|
| Week 16 |
-1.07
(0.940)
|
-1.00
(1.089)
|
-1.11
(1.089)
|
-0.96
(1.040)
|
| Week 16 (LOCF) |
-0.97
(0.948)
|
-1.00
(1.089)
|
-1.04
(1.412)
|
-0.94
(1.027)
|
| Title | Change From Baseline in the Volume Voided Per Micturition |
|---|---|
| Description | Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis. |
| Time Frame | Baseline and week 8, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 33 | 37 | 55 | 93 |
| Week 8 |
22.120
(26.2220)
|
19.380
(31.5492)
|
33.781
(32.6029)
|
24.821
(35.8941)
|
| Week16 |
28.532
(32.2243)
|
33.031
(38.2492)
|
35.780
(33.8236)
|
36.921
(43.8896)
|
| Week 16 (LOCF) |
29.865
(32.5400)
|
33.031
(38.2492)
|
34.118
(32.6790)
|
36.957
(43.6344)
|
| Title | Change From Baseline in the Number of Nocturia Episodes Per Night |
|---|---|
| Description | Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis. |
| Time Frame | Baseline and week 4, 8, 12, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis. |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Patients received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Patients received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. |
| Measure Participants | 28 | 29 | 50 | 81 |
| Week 4 |
0.17
(1,122)
|
-0.07
(0.787)
|
-0.45
(0.709)
|
-0.27
(0.738)
|
| Week 8 |
-0.38
(0.681)
|
-0.21
(0.688)
|
-0.37
(0.682)
|
-0.44
(0.825)
|
| Week 12 |
-0.35
(0.704)
|
-0.48
(0.796)
|
-0.29
(0.829)
|
-0.58
(0.916)
|
| Week 16 |
-0.38
(0.881)
|
-0.31
(0.674)
|
-0.44
(0.813)
|
-0.61
(0.992)
|
| Week 16 (LOCF) |
-0.43
(0.847)
|
-0.31
(0.674)
|
-0.44
(0.812)
|
-0.60
(0.982)
|
| Title | Change From Baseline in Postvoid Residual (PVR) Volume |
|---|---|
| Description | Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. |
| Time Frame | Baseline and week 4, 8, 12, 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF |
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg." |
| Measure Participants | 35 | 37 | 58 | 93 |
| Week 4 |
-4.95
(18.078)
|
5.88
(17.709)
|
13.78
(35.702)
|
4.36
(20.797)
|
| Week 8 |
-2.83
(19.442)
|
5.07
(19.512)
|
11.05
(32.310)
|
1.87
(13.428)
|
| Week 12 |
-2.53
(21.047)
|
5.29
(22.163)
|
6.51
(22.067)
|
1.17
(17.997)
|
| Week 16 |
0.63
(24.102)
|
3.96
(14.897)
|
7.31
(22.754)
|
3.60
(24.223)
|
| Week 16 (LOCF) |
-0.42
(23.576)
|
3.96
(14.897)
|
8.00
(28.833)
|
3.17
(24.144)
|
Adverse Events
| Time Frame | From first dose of study drug up to week 16 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period. | |||||||
| Arm/Group Title | Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg | ||||
| Arm/Group Description | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks. | Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg. | ||||
All Cause Mortality |
||||||||
| Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 0/93 (0%) | ||||
Serious Adverse Events |
||||||||
| Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/35 (2.9%) | 1/37 (2.7%) | 5/58 (8.6%) | 4/93 (4.3%) | ||||
| Cardiac disorders | ||||||||
| Atrial fibrillation | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 1/93 (1.1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Foot fracture | 0/35 (0%) | 1/37 (2.7%) | 0/58 (0%) | 0/93 (0%) | ||||
| Laceration | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Patella fracture | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Rib fracture | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 2/93 (2.2%) | ||||
| Investigations | ||||||||
| Blood pressure increased | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Blood urea increased | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| ECG ST segment depression | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Polymyalgia rheumatica | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 1/93 (1.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Urticaria | 1/35 (2.9%) | 0/37 (0%) | 0/58 (0%) | 0/93 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Solifenacin 2.5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 23/35 (65.7%) | 21/37 (56.8%) | 39/58 (67.2%) | 67/93 (72%) | ||||
| Eye disorders | ||||||||
| Conjunctival haemorrhage | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 2/93 (2.2%) | ||||
| Dry eye | 1/35 (2.9%) | 0/37 (0%) | 0/58 (0%) | 0/93 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 2/93 (2.2%) | ||||
| Abdominal distension | 2/35 (5.7%) | 0/37 (0%) | 0/58 (0%) | 0/93 (0%) | ||||
| Constipation | 2/35 (5.7%) | 2/37 (5.4%) | 5/58 (8.6%) | 7/93 (7.5%) | ||||
| Diarrhoea | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 4/93 (4.3%) | ||||
| Gastrooesophageal reflux disease | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 2/93 (2.2%) | ||||
| Dry Mouth | 0/35 (0%) | 1/37 (2.7%) | 0/58 (0%) | 0/93 (0%) | ||||
| General disorders | ||||||||
| Thirst | 1/35 (2.9%) | 0/37 (0%) | 1/58 (1.7%) | 3/93 (3.2%) | ||||
| Infections and infestations | ||||||||
| Cystitis | 3/35 (8.6%) | 1/37 (2.7%) | 1/58 (1.7%) | 4/93 (4.3%) | ||||
| Gastroenteritis | 1/35 (2.9%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Pharyngitis | 0/35 (0%) | 1/37 (2.7%) | 1/58 (1.7%) | 1/93 (1.1%) | ||||
| Urinary tract infection | 1/35 (2.9%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Nasopharyngitis | 4/35 (11.4%) | 3/37 (8.1%) | 5/58 (8.6%) | 6/93 (6.5%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Thermal burn | 0/35 (0%) | 1/37 (2.7%) | 0/58 (0%) | 1/93 (1.1%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/35 (0%) | 1/37 (2.7%) | 3/58 (5.2%) | 2/93 (2.2%) | ||||
| Aspartate aminotransferase increased | 0/35 (0%) | 1/37 (2.7%) | 3/58 (5.2%) | 3/93 (3.2%) | ||||
| Blood alkaline phosphatase increased | 1/35 (2.9%) | 1/37 (2.7%) | 1/58 (1.7%) | 3/93 (3.2%) | ||||
| Blood bilirubin increased | 0/35 (0%) | 1/37 (2.7%) | 2/58 (3.4%) | 0/93 (0%) | ||||
| Blood cholesterol increased | 2/35 (5.7%) | 2/37 (5.4%) | 0/58 (0%) | 3/93 (3.2%) | ||||
| Blood creatine phosphokinase increased | 4/35 (11.4%) | 5/37 (13.5%) | 6/58 (10.3%) | 13/93 (14%) | ||||
| Blood creatinine increased | 1/35 (2.9%) | 0/37 (0%) | 1/58 (1.7%) | 3/93 (3.2%) | ||||
| Blood potassium increased | 0/35 (0%) | 0/37 (0%) | 1/58 (1.7%) | 2/93 (2.2%) | ||||
| Blood pressure increased | 0/35 (0%) | 0/37 (0%) | 2/58 (3.4%) | 0/93 (0%) | ||||
| Blood urea increased | 3/35 (8.6%) | 3/37 (8.1%) | 8/58 (13.8%) | 15/93 (16.1%) | ||||
| Blood uric acid decreased | 0/35 (0%) | 1/37 (2.7%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| Gamma-glutamyltransferase increased | 3/35 (8.6%) | 3/37 (8.1%) | 3/58 (5.2%) | 8/93 (8.6%) | ||||
| Glucose urine present | 2/35 (5.7%) | 0/37 (0%) | 3/58 (5.2%) | 3/93 (3.2%) | ||||
| Platelet count increased | 1/35 (2.9%) | 0/37 (0%) | 0/58 (0%) | 0/93 (0%) | ||||
| Protein urine present | 0/35 (0%) | 2/37 (5.4%) | 0/58 (0%) | 0/93 (0%) | ||||
| Urinary sediment abnormal | 5/35 (14.3%) | 1/37 (2.7%) | 3/58 (5.2%) | 7/93 (7.5%) | ||||
| White blood cell count decreased | 2/35 (5.7%) | 3/37 (8.1%) | 1/58 (1.7%) | 6/93 (6.5%) | ||||
| White blood cell count increased | 1/35 (2.9%) | 0/37 (0%) | 1/58 (1.7%) | 0/93 (0%) | ||||
| White blood cells urine positive | 2/35 (5.7%) | 0/37 (0%) | 1/58 (1.7%) | 1/93 (1.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Musculoskeletal stiffness | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 2/93 (2.2%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 1/35 (2.9%) | 0/37 (0%) | 2/58 (3.4%) | 1/93 (1.1%) | ||||
| Headache | 0/35 (0%) | 1/37 (2.7%) | 1/58 (1.7%) | 1/93 (1.1%) | ||||
| Somnolence | 0/35 (0%) | 0/37 (0%) | 0/58 (0%) | 2/93 (2.2%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Upper respiratory tract inflammation | 0/35 (0%) | 1/37 (2.7%) | 0/58 (0%) | 1/93 (1.1%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 1/35 (2.9%) | 0/37 (0%) | 0/58 (0%) | 0/93 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Astellas Pharma Inc. |
| Phone | +81-3-3244-0512 Ext: |
| motoko.ida@astellas.com |
Responsible Party:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01745094
Other Study ID Numbers:
- 178-CL-110
First Posted:
Dec 7, 2012
Last Update Posted:
Feb 28, 2018
Last Verified:
Dec 1, 2017