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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01972841
Registration number
NCT01972841
Ethics application status
Date submitted
25/10/2013
Date registered
31/10/2013
Date last updated
1/11/2018
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
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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
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Secondary ID [1]
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2012-005735-91
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Secondary ID [2]
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178-CL-101
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Universal Trial Number (UTN)
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Trial acronym
SYNERGY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Overactive
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Urinary Bladder Diseases\Urologic Diseases
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Overactive Bladder
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Urgency Incontinence
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
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Assessment method [1]
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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 from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
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Timepoint [1]
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Baseline and EoT (up to 12 weeks)
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Primary outcome [2]
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Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
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Assessment method [2]
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A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
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Timepoint [2]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [1]
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Change From Baseline to EoT in Mean Volume Voided Per Micturition
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Assessment method [1]
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The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
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Timepoint [1]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [2]
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Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
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Assessment method [2]
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The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, 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). A negative change from baseline indicates an improvement.
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Timepoint [2]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [3]
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Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
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Assessment method [3]
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The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
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Timepoint [3]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [4]
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Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
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Assessment method [4]
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The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.
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Timepoint [4]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [5]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
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Assessment method [5]
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Timepoint [5]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [6]
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Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
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Assessment method [6]
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Timepoint [6]
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Baseline and weeks 4, 8 and 12
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Secondary outcome [7]
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Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
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Assessment method [7]
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Timepoint [7]
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Baseline and weeks 4, 8 and 12
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Secondary outcome [8]
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Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
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Assessment method [8]
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Timepoint [8]
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Baseline and weeks 4, 8 and 12
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Secondary outcome [9]
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Change From Baseline to EoT in Corrected Micturition Frequency
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Assessment method [9]
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Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.
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Timepoint [9]
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Baseline and Week 12
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Secondary outcome [10]
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Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
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Assessment method [10]
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An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [10]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [11]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
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Assessment method [11]
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Timepoint [11]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [12]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
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Assessment method [12]
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The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [12]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [13]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
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Assessment method [13]
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An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [13]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [14]
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Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
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Assessment method [14]
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A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [14]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [15]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
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Assessment method [15]
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Timepoint [15]
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Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
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Secondary outcome [16]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
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Assessment method [16]
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The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [16]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [17]
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Number of Pads Used at Weeks 4, 8, 12 and EoT
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Assessment method [17]
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The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [17]
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Weeks 4, 8 and 12 (up to 12 weeks)
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Secondary outcome [18]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
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Assessment method [18]
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Timepoint [18]
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Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
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Secondary outcome [19]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
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Assessment method [19]
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The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
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Timepoint [19]
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Baseline and weeks 4, 8 and 12 (up to 12 weeks)
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Secondary outcome [20]
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Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
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Assessment method [20]
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The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.
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Timepoint [20]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [21]
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Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
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Assessment method [21]
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The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.
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Timepoint [21]
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Weeks 4, 8,12 and EoT (up to 12 weeks)
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Secondary outcome [22]
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Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
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Assessment method [22]
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The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.
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Timepoint [22]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [23]
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Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
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Assessment method [23]
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The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated 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.
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Timepoint [23]
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Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)
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Secondary outcome [24]
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Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
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Assessment method [24]
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The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, 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). A negative change from baseline indicated an improvement.
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Timepoint [24]
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Baseline and weeks 4, 8 and 12
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Secondary outcome [25]
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score
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Assessment method [25]
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The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL 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 positive change from baseline indicated an improvement.
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Timepoint [25]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [26]
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
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Assessment method [26]
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The Coping score was calculated by adding 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.
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Timepoint [26]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [27]
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
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Assessment method [27]
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The Concern score was calculated by adding 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.
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Timepoint [27]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [28]
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
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Assessment method [28]
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The Sleep score was calculated by adding 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.
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Timepoint [28]
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Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [29]
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
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Assessment method [29]
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The Social score was calculated by adding 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.
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Timepoint [29]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [30]
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Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
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Assessment method [30]
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The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
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Timepoint [30]
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Week 12 and EoT (up to 12 weeks)
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Secondary outcome [31]
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PGIC Scale: Impression in General Health at Week 12 and EoT
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Assessment method [31]
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The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
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Timepoint [31]
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Week 12 and EoT (up to 12 weeks)
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Secondary outcome [32]
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Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
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Assessment method [32]
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The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [32]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [33]
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
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Assessment method [33]
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The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [33]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [34]
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
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Assessment method [34]
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The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [34]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [35]
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
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Assessment method [35]
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The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [35]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [36]
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
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Assessment method [36]
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0
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [36]
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Baseline and EoT (up to 12 weeks)
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Secondary outcome [37]
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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
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Assessment method [37]
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The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
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Timepoint [37]
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Baseline and week 12 and EoT (up to 12 weeks)
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Secondary outcome [38]
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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
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Assessment method [38]
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0
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Timepoint [38]
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Baseline and week 12 and EoT (up to 12 weeks)
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Secondary outcome [39]
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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
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Assessment method [39]
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0
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Timepoint [39]
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Baseline and week 12 and EoT (up to 12 weeks)
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Secondary outcome [40]
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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
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Assessment method [40]
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0
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Timepoint [40]
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Baseline and week 12 and EoT (up to 12 weeks)
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Secondary outcome [41]
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Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
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Assessment method [41]
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The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
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Timepoint [41]
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Baseline and week 4, 8 and 12
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Secondary outcome [42]
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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
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Assessment method [42]
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The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.
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Timepoint [42]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [43]
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Percentage of Participants With = 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
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Assessment method [43]
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The percentage of participants with = 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
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Timepoint [43]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [44]
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Percentage of Participants With = 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
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Assessment method [44]
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The percentage of participants with = 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
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Timepoint [44]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [45]
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Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
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Assessment method [45]
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The percentage of participants with = 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).
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Timepoint [45]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [46]
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Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
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Assessment method [46]
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The percentage of participants with micturition frequency normalization was defined as any participant who had = 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.
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Timepoint [46]
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Weeks 4, 8 , 12 and EoT (up to 12 weeks)
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Secondary outcome [47]
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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
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Assessment method [47]
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The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.
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Timepoint [47]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [48]
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Percentage of Participants With = 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
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Assessment method [48]
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The percentage of participants with = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
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Timepoint [48]
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Weeks 4, 8, 12 and EoT (up to 12 weeks)
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Secondary outcome [49]
0
0
Percentage of Participants With Major (= 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Query!
Assessment method [49]
0
0
The percentage of participants with a major (= 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Query!
Timepoint [49]
0
0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
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
Query!
Assessment method [50]
0
0
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by = 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.
Query!
Timepoint [50]
0
0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
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
Query!
Assessment method [51]
0
0
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by = 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.
Query!
Timepoint [51]
0
0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
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
Query!
Assessment method [52]
0
0
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Query!
Timepoint [52]
0
0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
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
Query!
Assessment method [53]
0
0
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by = 10 points) on the OAB-q Symptom Bother score, and = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Query!
Timepoint [53]
0
0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
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
Query!
Assessment method [54]
0
0
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by = 10 points) on the HRQL total score, and = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Query!
Timepoint [54]
0
0
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [55]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Query!
Assessment method [55]
0
0
A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.
Query!
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)
Query!
Secondary outcome [56]
0
0
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
Query!
Assessment method [56]
0
0
PVR volume was assessed by ultrasonography or a bladder scanner.
Query!
Timepoint [56]
0
0
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Query!
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)
Query!
Assessment method [57]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Query!
Timepoint [57]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
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)
Query!
Assessment method [58]
0
0
Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Query!
Timepoint [58]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
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)
Query!
Assessment method [59]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Query!
Timepoint [59]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
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
Query!
Assessment method [60]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.
Query!
Timepoint [60]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [61]
0
0
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Query!
Assessment method [61]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Query!
Timepoint [61]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [62]
0
0
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Query!
Assessment method [62]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Query!
Timepoint [62]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [63]
0
0
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Query!
Assessment method [63]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Query!
Timepoint [63]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [64]
0
0
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Query!
Assessment method [64]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Query!
Timepoint [64]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [65]
0
0
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Query!
Assessment method [65]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Query!
Timepoint [65]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [66]
0
0
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Query!
Assessment method [66]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Query!
Timepoint [66]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [67]
0
0
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Query!
Assessment method [67]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Query!
Timepoint [67]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
Secondary outcome [68]
0
0
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Query!
Assessment method [68]
0
0
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Query!
Timepoint [68]
0
0
Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Query!
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;
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/11/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
22/10/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
3527
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Site AU61026 Ballarat Urology - Ballarat
Query!
Recruitment hospital [2]
0
0
Site AU61022 Brisbane South Clinical Research Centre - Brisbane
Query!
Recruitment hospital [3]
0
0
Site AU61005 Hunter Clinical Research - Broadmeadow
Query!
Recruitment hospital [4]
0
0
Site AU61015 Repatriation General Hospital - Daw Park
Query!
Recruitment hospital [5]
0
0
Site AU61025 Western Health - Footscray
Query!
Recruitment hospital [6]
0
0
Site AU61012 Cabrini Hospital - Malvern
Query!
Recruitment hospital [7]
0
0
Site AU61010 Nambour General Hospital - Nambour
Query!
Recruitment hospital [8]
0
0
Site AU61002 The Royal Womens Hospital - Parkville
Query!
Recruitment hospital [9]
0
0
Site AU61004 Keogh Institute for Medical Research - Perth
Query!
Recruitment hospital [10]
0
0
Site AU61007 Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [11]
0
0
Site AU61008 Epworth Healthcare - Richmond
Query!
Recruitment hospital [12]
0
0
Site AU61019 AusTrialsSherwood - Sherwood
Query!
Recruitment hospital [13]
0
0
Site AU61017 Healthpac Medical Centre - Sydney
Query!
Recruitment hospital [14]
0
0
Site AU61021 Royal Hospital for Women - Sydney
Query!
Recruitment hospital [15]
0
0
Site AU61011 Illawarra Health and Medical Research Institute - Wollongong
Query!
Recruitment postcode(s) [1]
0
0
3350 - Ballarat
Query!
Recruitment postcode(s) [2]
0
0
4152 - Brisbane
Query!
Recruitment postcode(s) [3]
0
0
2292 - Broadmeadow
Query!
Recruitment postcode(s) [4]
0
0
5041 - Daw Park
Query!
Recruitment postcode(s) [5]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [6]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [7]
0
0
4560 - Nambour
Query!
Recruitment postcode(s) [8]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [9]
0
0
6009 - Perth
Query!
Recruitment postcode(s) [10]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [11]
0
0
3121 - Richmond
Query!
Recruitment postcode(s) [12]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [13]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [14]
0
0
2031 - Sydney
Query!
Recruitment postcode(s) [15]
0
0
2522 - Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Montana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Mexico
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Utah
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Buenos Aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Ciudad Autónoma Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Rosario Provincia De Santa Fe
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Gent
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Leuven
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Roeselare
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Sint-Truiden
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Pleven
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Plovdiv
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Ruse
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sofia
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Varna
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Veliko Tarnovo
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
British Columbia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
New Brunswick
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Ontario
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Quebec
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Fujian
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Beijing
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Changchun
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Changsha
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Chengdu
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Chongqing
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Guangzhou
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Lan Zhou
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Lanzhou
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Nanchang
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Nanjing
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Shanghai
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Suzhou
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Wenzhou
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Wuhan
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Wuxi
Query!
Country [65]
0
0
Colombia
Query!
State/province [65]
0
0
Antioquia
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Medellin
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Brno
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Hradec Kralove
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Jihlava
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Novy Jicin
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Olomouc
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Ostrava
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Plzen
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Praha 4
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Sternberk
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Uherske Hradiste
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Usti nad Labem
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Aalborg
Query!
Country [79]
0
0
Denmark
Query!
State/province [79]
0
0
Aarhus
Query!
Country [80]
0
0
Estonia
Query!
State/province [80]
0
0
Parnu
Query!
Country [81]
0
0
Estonia
Query!
State/province [81]
0
0
Tallinn
Query!
Country [82]
0
0
Estonia
Query!
State/province [82]
0
0
Tartu
Query!
Country [83]
0
0
Finland
Query!
State/province [83]
0
0
Kouvola
Query!
Country [84]
0
0
Finland
Query!
State/province [84]
0
0
Oulu
Query!
Country [85]
0
0
Finland
Query!
State/province [85]
0
0
Vantaa
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Colmar Cedex
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Dijon
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Nantes Cedex 1
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Nimes Cedex
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Paris Cedex 20
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Paris
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Pierre Benite Cedex
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Suresnes
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Tours Cedex 9
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Bad Ems
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Bergisch Gladbach
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Bonn
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Duisburg
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Ganderkesee
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Halle (Saale)
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Leipzig
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Lutherstadt Eisleben
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Munich
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Neustadt I. Sachsen
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Rostock
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Sangerhausen
Query!
Country [107]
0
0
Greece
Query!
State/province [107]
0
0
Athens
Query!
Country [108]
0
0
Hong Kong
Query!
State/province [108]
0
0
Hong Kong
Query!
Country [109]
0
0
Hong Kong
Query!
State/province [109]
0
0
Kowloon
Query!
Country [110]
0
0
Hong Kong
Query!
State/province [110]
0
0
Shatin
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Csongrád
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Kecskemet
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Pecs
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Sopron
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Szentes
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Veszprém
Query!
Country [117]
0
0
Italy
Query!
State/province [117]
0
0
Ancona
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
Avellino
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Latina
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Milano
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Milan
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Bucheon-Si
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Busan
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Cheongju-si
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Daegu
Query!
Country [126]
0
0
Korea, Republic of
Query!
State/province [126]
0
0
Daejeon
Query!
Country [127]
0
0
Korea, Republic of
Query!
State/province [127]
0
0
Gwangju
Query!
Country [128]
0
0
Korea, Republic of
Query!
State/province [128]
0
0
Iksan -Si
Query!
Country [129]
0
0
Korea, Republic of
Query!
State/province [129]
0
0
Incheon
Query!
Country [130]
0
0
Korea, Republic of
Query!
State/province [130]
0
0
Jeonju-si
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Seongnam-si
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Seoul
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Suwon-si
Query!
Country [134]
0
0
Latvia
Query!
State/province [134]
0
0
Liepaja
Query!
Country [135]
0
0
Latvia
Query!
State/province [135]
0
0
Olaine
Query!
Country [136]
0
0
Latvia
Query!
State/province [136]
0
0
Riga
Query!
Country [137]
0
0
Lithuania
Query!
State/province [137]
0
0
Kaunas
Query!
Country [138]
0
0
Lithuania
Query!
State/province [138]
0
0
Klaipeda
Query!
Country [139]
0
0
Lithuania
Query!
State/province [139]
0
0
Vilnius
Query!
Country [140]
0
0
Malaysia
Query!
State/province [140]
0
0
Georgetown
Query!
Country [141]
0
0
Malaysia
Query!
State/province [141]
0
0
Kuala Lumpur
Query!
Country [142]
0
0
Malaysia
Query!
State/province [142]
0
0
Kuching
Query!
Country [143]
0
0
Malaysia
Query!
State/province [143]
0
0
Petaling Jaya
Query!
Country [144]
0
0
Mexico
Query!
State/province [144]
0
0
Durango
Query!
Country [145]
0
0
Mexico
Query!
State/province [145]
0
0
Guadalajara
Query!
Country [146]
0
0
Mexico
Query!
State/province [146]
0
0
Mexico City
Query!
Country [147]
0
0
Mexico
Query!
State/province [147]
0
0
Monterrey
Query!
Country [148]
0
0
Netherlands
Query!
State/province [148]
0
0
Amsterdam
Query!
Country [149]
0
0
Netherlands
Query!
State/province [149]
0
0
Enschede
Query!
Country [150]
0
0
Netherlands
Query!
State/province [150]
0
0
Nijmegen
Query!
Country [151]
0
0
Netherlands
Query!
State/province [151]
0
0
Sneek
Query!
Country [152]
0
0
Netherlands
Query!
State/province [152]
0
0
Utrecht
Query!
Country [153]
0
0
New Zealand
Query!
State/province [153]
0
0
Auckland
Query!
Country [154]
0
0
New Zealand
Query!
State/province [154]
0
0
Christchurch
Query!
Country [155]
0
0
New Zealand
Query!
State/province [155]
0
0
Hamilton
Query!
Country [156]
0
0
New Zealand
Query!
State/province [156]
0
0
Nelson
Query!
Country [157]
0
0
New Zealand
Query!
State/province [157]
0
0
Tauranga
Query!
Country [158]
0
0
New Zealand
Query!
State/province [158]
0
0
Whangarei
Query!
Country [159]
0
0
Norway
Query!
State/province [159]
0
0
Hamar
Query!
Country [160]
0
0
Norway
Query!
State/province [160]
0
0
Lierskogen
Query!
Country [161]
0
0
Norway
Query!
State/province [161]
0
0
Ålesund
Query!
Country [162]
0
0
Peru
Query!
State/province [162]
0
0
Lima
Query!
Country [163]
0
0
Philippines
Query!
State/province [163]
0
0
Bacolod City
Query!
Country [164]
0
0
Philippines
Query!
State/province [164]
0
0
Davao City
Query!
Country [165]
0
0
Philippines
Query!
State/province [165]
0
0
Manila
Query!
Country [166]
0
0
Philippines
Query!
State/province [166]
0
0
Quezon City
Query!
Country [167]
0
0
Poland
Query!
State/province [167]
0
0
Bialystok
Query!
Country [168]
0
0
Poland
Query!
State/province [168]
0
0
Chorzow
Query!
Country [169]
0
0
Poland
Query!
State/province [169]
0
0
Gdynia
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Lodz
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Lublin
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Myslowice
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Opole
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Piaseczno
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Warsaw
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Warszawa
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Wroclaw
Query!
Country [178]
0
0
Romania
Query!
State/province [178]
0
0
Brasov
Query!
Country [179]
0
0
Romania
Query!
State/province [179]
0
0
Bucuresti
Query!
Country [180]
0
0
Romania
Query!
State/province [180]
0
0
Cluj-Napoca
Query!
Country [181]
0
0
Romania
Query!
State/province [181]
0
0
Iasi
Query!
Country [182]
0
0
Romania
Query!
State/province [182]
0
0
Sibiu
Query!
Country [183]
0
0
Romania
Query!
State/province [183]
0
0
Timisoara
Query!
Country [184]
0
0
Russian Federation
Query!
State/province [184]
0
0
Kazan
Query!
Country [185]
0
0
Russian Federation
Query!
State/province [185]
0
0
Penza
Query!
Country [186]
0
0
Russian Federation
Query!
State/province [186]
0
0
Saint Petersburg
Query!
Country [187]
0
0
Russian Federation
Query!
State/province [187]
0
0
St. Petersburg
Query!
Country [188]
0
0
Russian Federation
Query!
State/province [188]
0
0
Ufa
Query!
Country [189]
0
0
Singapore
Query!
State/province [189]
0
0
Singapore
Query!
Country [190]
0
0
Slovakia
Query!
State/province [190]
0
0
Bratislava
Query!
Country [191]
0
0
Slovakia
Query!
State/province [191]
0
0
Kosice
Query!
Country [192]
0
0
Slovakia
Query!
State/province [192]
0
0
Nitra
Query!
Country [193]
0
0
Slovakia
Query!
State/province [193]
0
0
Poprad
Query!
Country [194]
0
0
Slovakia
Query!
State/province [194]
0
0
Presov
Query!
Country [195]
0
0
Slovakia
Query!
State/province [195]
0
0
Trencin
Query!
Country [196]
0
0
Slovenia
Query!
State/province [196]
0
0
Murska Sobota
Query!
Country [197]
0
0
Slovenia
Query!
State/province [197]
0
0
Novo Mesto
Query!
Country [198]
0
0
South Africa
Query!
State/province [198]
0
0
Cape Town
Query!
Country [199]
0
0
South Africa
Query!
State/province [199]
0
0
Centurion
Query!
Country [200]
0
0
South Africa
Query!
State/province [200]
0
0
Durban
Query!
Country [201]
0
0
South Africa
Query!
State/province [201]
0
0
Meyerspark
Query!
Country [202]
0
0
South Africa
Query!
State/province [202]
0
0
Paarl
Query!
Country [203]
0
0
South Africa
Query!
State/province [203]
0
0
Roodepoort
Query!
Country [204]
0
0
Spain
Query!
State/province [204]
0
0
Coslada
Query!
Country [205]
0
0
Spain
Query!
State/province [205]
0
0
Esplugues De Llobregat-Barcelo
Query!
Country [206]
0
0
Spain
Query!
State/province [206]
0
0
Getafe (Madrid)
Query!
Country [207]
0
0
Spain
Query!
State/province [207]
0
0
Madrid
Query!
Country [208]
0
0
Spain
Query!
State/province [208]
0
0
Sevilla
Query!
Country [209]
0
0
Spain
Query!
State/province [209]
0
0
Valencia
Query!
Country [210]
0
0
Sweden
Query!
State/province [210]
0
0
Boras
Query!
Country [211]
0
0
Sweden
Query!
State/province [211]
0
0
Helsingborg
Query!
Country [212]
0
0
Sweden
Query!
State/province [212]
0
0
Malmö
Query!
Country [213]
0
0
Sweden
Query!
State/province [213]
0
0
Stockholm
Query!
Country [214]
0
0
Sweden
Query!
State/province [214]
0
0
Uppsala
Query!
Country [215]
0
0
Sweden
Query!
State/province [215]
0
0
Vällingby
Query!
Country [216]
0
0
Taiwan
Query!
State/province [216]
0
0
Taichung
Query!
Country [217]
0
0
Taiwan
Query!
State/province [217]
0
0
Tainan
Query!
Country [218]
0
0
Taiwan
Query!
State/province [218]
0
0
Taipei
Query!
Country [219]
0
0
Thailand
Query!
State/province [219]
0
0
Bangkok
Query!
Country [220]
0
0
Thailand
Query!
State/province [220]
0
0
Chiang Mai
Query!
Country [221]
0
0
Thailand
Query!
State/province [221]
0
0
Hat Yai
Query!
Country [222]
0
0
Thailand
Query!
State/province [222]
0
0
Khon Kaen
Query!
Country [223]
0
0
Thailand
Query!
State/province [223]
0
0
Pathum Thani
Query!
Country [224]
0
0
Thailand
Query!
State/province [224]
0
0
Ratchathewi
Query!
Country [225]
0
0
Turkey
Query!
State/province [225]
0
0
Ankara
Query!
Country [226]
0
0
Turkey
Query!
State/province [226]
0
0
Bursa
Query!
Country [227]
0
0
Turkey
Query!
State/province [227]
0
0
Denizli
Query!
Country [228]
0
0
Turkey
Query!
State/province [228]
0
0
Istanbul
Query!
Country [229]
0
0
Ukraine
Query!
State/province [229]
0
0
Chernigov
Query!
Country [230]
0
0
Ukraine
Query!
State/province [230]
0
0
Chernivtsi
Query!
Country [231]
0
0
Ukraine
Query!
State/province [231]
0
0
Dnipropetrovsk
Query!
Country [232]
0
0
Ukraine
Query!
State/province [232]
0
0
Kharkiv
Query!
Country [233]
0
0
Ukraine
Query!
State/province [233]
0
0
Kiev
Query!
Country [234]
0
0
Ukraine
Query!
State/province [234]
0
0
Kyiv
Query!
Country [235]
0
0
Ukraine
Query!
State/province [235]
0
0
Uzhorod
Query!
Country [236]
0
0
Ukraine
Query!
State/province [236]
0
0
Vinnytsya
Query!
Country [237]
0
0
Ukraine
Query!
State/province [237]
0
0
Zaporizhzhya
Query!
Country [238]
0
0
United Kingdom
Query!
State/province [238]
0
0
Watfort
Query!
Country [239]
0
0
United Kingdom
Query!
State/province [239]
0
0
Crewe
Query!
Country [240]
0
0
United Kingdom
Query!
State/province [240]
0
0
Gillingham
Query!
Country [241]
0
0
United Kingdom
Query!
State/province [241]
0
0
Harrow
Query!
Country [242]
0
0
United Kingdom
Query!
State/province [242]
0
0
Leeds
Query!
Country [243]
0
0
United Kingdom
Query!
State/province [243]
0
0
London
Query!
Country [244]
0
0
United Kingdom
Query!
State/province [244]
0
0
Plymouth
Query!
Country [245]
0
0
United Kingdom
Query!
State/province [245]
0
0
Reading
Query!
Country [246]
0
0
United Kingdom
Query!
State/province [246]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Astellas Pharma Europe B.V.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01972841
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Public notes
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Contacts
Principal investigator
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Medical Director
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Astellas Pharma Europe B.V.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01972841
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