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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01972841




Registration number
NCT01972841
Ethics application status
Date submitted
25/10/2013
Date registered
31/10/2013
Date last updated
31/10/2024

Titles & IDs
Public title
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
Scientific title
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
Secondary ID [1] 0 0
2012-005735-91
Secondary ID [2] 0 0
178-CL-101
Universal Trial Number (UTN)
Trial acronym
SYNERGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Overactive 0 0
Urinary Bladder Diseases\Urologic Diseases 0 0
Overactive Bladder 0 0
Urgency Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Solifenacin succinate
Treatment: Drugs - Mirabegron
Treatment: Drugs - Placebo to match solifenacin succinate
Treatment: Drugs - Placebo to match mirabegron

Experimental: 1: Solifenacin 5 mg + Mirabegron 25 mg - Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

Experimental: 2: Solifenacin 5 mg + Mirabegron 50 mg - Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

Placebo comparator: 3: Placebo - Participants who received matching placebo once a day for 12 weeks.

Active comparator: 4: Solifenacin 5 mg - Participants who received solifenacin 5 mg once a day for 12 weeks.

Active comparator: 5:Mirabegron 25 mg - Participants who received mirabegron 25 mg once a day for 12 weeks.

Active comparator: 6: Mirabegron 50 mg - Participants who received mirabegron 50 mg once a day for 12 weeks.


Treatment: Drugs: Solifenacin succinate
Oral tablet

Treatment: Drugs: Mirabegron
Oral tablet

Treatment: Drugs: Placebo to match solifenacin succinate
Oral tablet

Treatment: Drugs: Placebo to match mirabegron
Oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [1] 0 0
Baseline and EoT (up to 12 weeks)
Primary outcome [2] 0 0
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
Timepoint [2] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [1] 0 0
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Timepoint [1] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [2] 0 0
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Timepoint [2] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [3] 0 0
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Timepoint [3] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [4] 0 0
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
Timepoint [4] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [5] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
Timepoint [5] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [6] 0 0
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [6] 0 0
Baseline and weeks 4, 8 and 12
Secondary outcome [7] 0 0
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
Timepoint [7] 0 0
Baseline and weeks 4, 8 and 12
Secondary outcome [8] 0 0
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
Timepoint [8] 0 0
Baseline and weeks 4, 8 and 12
Secondary outcome [9] 0 0
Change From Baseline to EoT in Corrected Micturition Frequency
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
Timepoint [10] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [11] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
Timepoint [11] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [12] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Timepoint [12] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [13] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Timepoint [13] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [14] 0 0
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
Timepoint [14] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [15] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
Timepoint [15] 0 0
Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
Secondary outcome [16] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Timepoint [16] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [17] 0 0
Number of Pads Used at Weeks 4, 8, 12 and EoT
Timepoint [17] 0 0
Weeks 4, 8 and 12 (up to 12 weeks)
Secondary outcome [18] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
Timepoint [18] 0 0
Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
Secondary outcome [19] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
Timepoint [19] 0 0
Baseline and weeks 4, 8 and 12 (up to 12 weeks)
Secondary outcome [20] 0 0
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
Timepoint [20] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [21] 0 0
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
Timepoint [21] 0 0
Weeks 4, 8,12 and EoT (up to 12 weeks)
Secondary outcome [22] 0 0
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
Timepoint [22] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [23] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
Timepoint [23] 0 0
Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)
Secondary outcome [24] 0 0
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
Timepoint [24] 0 0
Baseline and weeks 4, 8 and 12
Secondary outcome [25] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score
Timepoint [25] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [26] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
Timepoint [26] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [27] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
Timepoint [27] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [28] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
Timepoint [28] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [29] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
Timepoint [29] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [30] 0 0
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
Timepoint [30] 0 0
Week 12 and EoT (up to 12 weeks)
Secondary outcome [31] 0 0
PGIC Scale: Impression in General Health at Week 12 and EoT
Timepoint [31] 0 0
Week 12 and EoT (up to 12 weeks)
Secondary outcome [32] 0 0
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
Timepoint [32] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [33] 0 0
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
Timepoint [33] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [34] 0 0
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
Timepoint [34] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [35] 0 0
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
Timepoint [35] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [36] 0 0
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
Timepoint [36] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [37] 0 0
Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
Timepoint [37] 0 0
Baseline and week 12 and EoT (up to 12 weeks)
Secondary outcome [38] 0 0
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
Timepoint [38] 0 0
Baseline and week 12 and EoT (up to 12 weeks)
Secondary outcome [39] 0 0
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
Timepoint [39] 0 0
Baseline and week 12 and EoT (up to 12 weeks)
Secondary outcome [40] 0 0
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
Timepoint [40] 0 0
Baseline and week 12 and EoT (up to 12 weeks)
Secondary outcome [41] 0 0
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
Timepoint [41] 0 0
Baseline and week 4, 8 and 12
Secondary outcome [42] 0 0
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
Timepoint [42] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [43] 0 0
Percentage of Participants With = 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
Timepoint [43] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [44] 0 0
Percentage of Participants With = 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
Timepoint [44] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [45] 0 0
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
Timepoint [45] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [46] 0 0
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
Timepoint [46] 0 0
Weeks 4, 8 , 12 and EoT (up to 12 weeks)
Secondary outcome [47] 0 0
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
Timepoint [47] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [48] 0 0
Percentage of Participants With = 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Timepoint [48] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [49] 0 0
Percentage of Participants With Major (= 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Timepoint [49] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [50] 0 0
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
Timepoint [50] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [51] 0 0
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
Timepoint [51] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [52] 0 0
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Timepoint [52] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [53] 0 0
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Timepoint [53] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [54] 0 0
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Timepoint [54] 0 0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [55] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [55] 0 0
From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
Secondary outcome [56] 0 0
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
Timepoint [56] 0 0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary outcome [57] 0 0
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
Timepoint [57] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [58] 0 0
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
Timepoint [58] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [59] 0 0
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
Timepoint [59] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [60] 0 0
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
Timepoint [60] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [61] 0 0
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Timepoint [61] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [62] 0 0
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Timepoint [62] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [63] 0 0
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Timepoint [63] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [64] 0 0
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Timepoint [64] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [65] 0 0
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Timepoint [65] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [66] 0 0
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Timepoint [66] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [67] 0 0
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Timepoint [67] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary outcome [68] 0 0
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Timepoint [68] 0 0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Eligibility
Key inclusion criteria
* Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
* Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject had significant PVR volume (> 150 mL);
* Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
* Subject had an indwelling catheter or practices intermittent self catheterization.
* Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
* Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
* Subject had moderate to severe hepatic impairment
* Subject had severe renal impairment
* Subject had a clinically significant abnormal ECG
* Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
* Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
* Subject had severe hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diastolic blood pressure = 110 mmHg.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2015
Sample size
Target
Accrual to date
Final
3527
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site AU61026 Ballarat Urology - Ballarat
Recruitment hospital [2] 0 0
Site AU61022 Brisbane South Clinical Research Centre - Brisbane
Recruitment hospital [3] 0 0
Site AU61005 Hunter Clinical Research - Broadmeadow
Recruitment hospital [4] 0 0
Site AU61015 Repatriation General Hospital - Daw Park
Recruitment hospital [5] 0 0
Site AU61025 Western Health - Footscray
Recruitment hospital [6] 0 0
Site AU61012 Cabrini Hospital - Malvern
Recruitment hospital [7] 0 0
Site AU61010 Nambour General Hospital - Nambour
Recruitment hospital [8] 0 0
Site AU61002 The Royal Womens Hospital - Parkville
Recruitment hospital [9] 0 0
Site AU61004 Keogh Institute for Medical Research - Perth
Recruitment hospital [10] 0 0
Site AU61007 Prince of Wales Hospital - Randwick
Recruitment hospital [11] 0 0
Site AU61008 Epworth Healthcare - Richmond
Recruitment hospital [12] 0 0
Site AU61019 AusTrialsSherwood - Sherwood
Recruitment hospital [13] 0 0
Site AU61017 Healthpac Medical Centre - Sydney
Recruitment hospital [14] 0 0
Site AU61021 Royal Hospital for Women - Sydney
Recruitment hospital [15] 0 0
Site AU61011 Illawarra Health and Medical Research Institute - Wollongong
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
4152 - Brisbane
Recruitment postcode(s) [3] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [4] 0 0
5041 - Daw Park
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
4560 - Nambour
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Perth
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
3121 - Richmond
Recruitment postcode(s) [12] 0 0
4075 - Sherwood
Recruitment postcode(s) [13] 0 0
2000 - Sydney
Recruitment postcode(s) [14] 0 0
2031 - Sydney
Recruitment postcode(s) [15] 0 0
2522 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
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New York
Country [20] 0 0
United States of America
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North Carolina
Country [21] 0 0
United States of America
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Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autónoma Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Rosario Provincia De Santa Fe
Country [34] 0 0
Belgium
State/province [34] 0 0
Gent
Country [35] 0 0
Belgium
State/province [35] 0 0
Leuven
Country [36] 0 0
Belgium
State/province [36] 0 0
Roeselare
Country [37] 0 0
Belgium
State/province [37] 0 0
Sint-Truiden
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Pleven
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Plovdiv
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Ruse
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Sofia
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Varna
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Veliko Tarnovo
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Canada
State/province [45] 0 0
British Columbia
Country [46] 0 0
Canada
State/province [46] 0 0
New Brunswick
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
China
State/province [49] 0 0
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Europe B.V.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.
Trial website
https://clinicaltrials.gov/study/NCT01972841
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Europe B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01972841