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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02045862




Registration number
NCT02045862
Ethics application status
Date submitted
23/01/2014
Date registered
27/01/2014
Date last updated
31/10/2024

Titles & IDs
Public title
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
Scientific title
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder
Secondary ID [1] 0 0
2012-005736-29
Secondary ID [2] 0 0
178-CL-102
Universal Trial Number (UTN)
Trial acronym
SYNERGY II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Overactive 0 0
Overactive Bladder 0 0
Urgency Incontinence 0 0
Urinary Bladder Diseases\Urologic Diseases 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
Treatment: Drugs - Placebo to match mirabegron

Active comparator: Mirabegron 50 mg - Participants received mirabegron 50 mg once a day for 52 weeks.

Active comparator: Solifenacin 5 mg - Participants received solifenacin 5 mg once a day for 52 weeks.

Experimental: Solifenacin 5 mg + Mirabegron 50 mg - Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.


Treatment: Drugs: Solifenacin succinate
Participants received solifenacin 5 mg orally once a day at the same time each day.

Treatment: Drugs: Mirabegron
Participants received mirabegron 50 mg orally once a day at the same time each day.

Treatment: Drugs: Placebo to match solifenacin
Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Treatment: Drugs: Placebo to match mirabegron
Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
Primary outcome [2] 0 0
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [2] 0 0
Baseline and Week 52
Primary outcome [3] 0 0
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
Timepoint [3] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Timepoint [1] 0 0
Baseline and Week 52
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 Week 52
Secondary outcome [3] 0 0
Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Timepoint [3] 0 0
Baseline and Week 52
Secondary outcome [4] 0 0
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [4] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [5] 0 0
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [5] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [6] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [6] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [7] 0 0
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [7] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [8] 0 0
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [8] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [9] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Timepoint [9] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [10] 0 0
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [10] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [11] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [11] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [12] 0 0
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
Timepoint [12] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [13] 0 0
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
Timepoint [13] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [14] 0 0
Change From Baseline to EoT in Corrected Micturition Frequency
Timepoint [14] 0 0
Baseline and Month 12
Secondary outcome [15] 0 0
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
Timepoint [15] 0 0
Baseline and Months 3, 6, 12
Secondary outcome [16] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Timepoint [16] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [17] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Timepoint [17] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [18] 0 0
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [18] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [19] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [19] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [20] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
Timepoint [20] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [21] 0 0
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [21] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [22] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
Timepoint [22] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [23] 0 0
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
Timepoint [23] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [24] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
Timepoint [24] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [25] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
Timepoint [25] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [26] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
Timepoint [26] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [27] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
Timepoint [27] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [28] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
Timepoint [28] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [29] 0 0
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
Timepoint [29] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [30] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
Timepoint [30] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [31] 0 0
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
Timepoint [31] 0 0
Month 12
Secondary outcome [32] 0 0
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
Timepoint [32] 0 0
Month 12
Secondary outcome [33] 0 0
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
Timepoint [33] 0 0
Baseline and 12 Months
Secondary outcome [34] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
Timepoint [34] 0 0
Baseline and Month 12
Secondary outcome [35] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
Timepoint [35] 0 0
Baseline and Month 12
Secondary outcome [36] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
Timepoint [36] 0 0
Baseline and Month 12
Secondary outcome [37] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
Timepoint [37] 0 0
Baseline and Month 12
Secondary outcome [38] 0 0
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
Timepoint [38] 0 0
Baseline and Months 6,12
Secondary outcome [39] 0 0
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
Timepoint [39] 0 0
Baseline and Months 6, 12
Secondary outcome [40] 0 0
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
Timepoint [40] 0 0
Baseline and Months 6, 12
Secondary outcome [41] 0 0
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
Timepoint [41] 0 0
Baseline and Months 6, 12
Secondary outcome [42] 0 0
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
Timepoint [42] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [43] 0 0
Percentage of Participants With = 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
Timepoint [43] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [44] 0 0
Percentage of Participants With = 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
Timepoint [44] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [45] 0 0
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
Timepoint [45] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [46] 0 0
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
Timepoint [46] 0 0
Months 1, 3, 6, 9, 12
Secondary outcome [47] 0 0
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
Timepoint [47] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [48] 0 0
Percentage of Participants With = 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
Timepoint [48] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [49] 0 0
Percentage of Participants With Major (= 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
Timepoint [49] 0 0
Baseline and Months 1, 3, 6, 9, 12
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 Months 1, 3, 6, 9, 12 and EoT
Timepoint [50] 0 0
Baseline and Months 1, 3, 6, 9, 12
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 Months 1, 3, 6, 9, 12 and EoT
Timepoint [51] 0 0
Baseline and Months 1, 3, 6, 9, 12
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 Months 1, 3, 6, 9, 12 and EoT
Timepoint [52] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [53] 0 0
Percentage of Participants Who Were Triple Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, = 10 Points Improvement on OAB-q Symptom Bother Scale and =1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Timepoint [53] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [54] 0 0
Participants Who Were Triple Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, = 10 Points Improvement on OAB-q HRQL Total Score and = 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Timepoint [54] 0 0
Baseline and Months 1, 3, 6, 9, 12
Secondary outcome [55] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
Timepoint [55] 0 0
Baseline and Months 1, 3, 6, 9, 12

Eligibility
Key inclusion criteria
Main Inclusion at Screening (Visit 1):

* Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);
* 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;

Main Inclusion at Randomization (Visit 2):

* Subject had a micturition frequency of on average = 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition).
* Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
* Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Main Exclusion at Screening (Visit 1):

* Subject had clinically significant bladder outflow obstruction at risk of urinary retention;
* Subject had significant PVR volume (> 150 mL);
* Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor;
* Subject has an indwelling catheter or practices intermittent self-catheterization;
* Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
* Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;

Main Exclusion at Randomization (Visit 2):

* Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite).
* Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period.

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 administering the treatment/s
The people assessing the outcomes
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
17/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/09/2016
Sample size
Target
Accrual to date
Final
1829
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Site AU61005 - Broadmeadow
Recruitment hospital [2] 0 0
Site AU61007 - Randwick
Recruitment hospital [3] 0 0
Site AU61021 - Randwick
Recruitment hospital [4] 0 0
Site AU61011 - Wollongong
Recruitment hospital [5] 0 0
Site AU61022 - Brisbane
Recruitment hospital [6] 0 0
Site AU61010 - Nambour
Recruitment hospital [7] 0 0
Site AU61019 - Sherwood
Recruitment hospital [8] 0 0
Site AU61015 - Daw Park
Recruitment hospital [9] 0 0
Site AU61025 - Footscray
Recruitment hospital [10] 0 0
Site AU61002 - Parkville
Recruitment hospital [11] 0 0
Site AU61004 - Perth
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2522 - Wollongong
Recruitment postcode(s) [4] 0 0
4152 - Brisbane
Recruitment postcode(s) [5] 0 0
4560 - Nambour
Recruitment postcode(s) [6] 0 0
4075 - Sherwood
Recruitment postcode(s) [7] 0 0
5041 - Daw Park
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
3052 - Parkville
Recruitment postcode(s) [10] 0 0
6009 - Perth
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
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
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Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Belgium
State/province [27] 0 0
Roeselare
Country [28] 0 0
Belgium
State/province [28] 0 0
Sint-Truiden
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Ruse
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Sofia
Country [32] 0 0
Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
New Brunswick
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Canada
State/province [37] 0 0
Montreal
Country [38] 0 0
Czechia
State/province [38] 0 0
Brno
Country [39] 0 0
Czechia
State/province [39] 0 0
Hradec Kralove
Country [40] 0 0
Czechia
State/province [40] 0 0
Olomouc
Country [41] 0 0
Czechia
State/province [41] 0 0
Ostrava
Country [42] 0 0
Czechia
State/province [42] 0 0
Plzen
Country [43] 0 0
Czechia
State/province [43] 0 0
Praha 2
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 4
Country [45] 0 0
Czechia
State/province [45] 0 0
Sternberk
Country [46] 0 0
Czechia
State/province [46] 0 0
Uherske Hradiste
Country [47] 0 0
Czechia
State/province [47] 0 0
Usti nad Labem
Country [48] 0 0
Denmark
State/province [48] 0 0
Aarhus
Country [49] 0 0
Estonia
State/province [49] 0 0
Parnu
Country [50] 0 0
Finland
State/province [50] 0 0
Kouvola
Country [51] 0 0
Germany
State/province [51] 0 0
Bavaria
Country [52] 0 0
Germany
State/province [52] 0 0
Northwest
Country [53] 0 0
Germany
State/province [53] 0 0
NRW
Country [54] 0 0
Germany
State/province [54] 0 0
Sachsen Anhalt
Country [55] 0 0
Germany
State/province [55] 0 0
Sachsen
Country [56] 0 0
Germany
State/province [56] 0 0
Bad Ems
Country [57] 0 0
Germany
State/province [57] 0 0
Duisburg
Country [58] 0 0
Germany
State/province [58] 0 0
Ganderkesee
Country [59] 0 0
Germany
State/province [59] 0 0
Halle (Saale)
Country [60] 0 0
Germany
State/province [60] 0 0
Neustadt I. Sachsen
Country [61] 0 0
Germany
State/province [61] 0 0
Rostock
Country [62] 0 0
Germany
State/province [62] 0 0
Sangerhausen
Country [63] 0 0
Hungary
State/province [63] 0 0
Bacs-Kiskun Megye
Country [64] 0 0
Hungary
State/province [64] 0 0
Baranya Megye
Country [65] 0 0
Hungary
State/province [65] 0 0
Csongrad Megye
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyor-Moson Sopron
Country [67] 0 0
Hungary
State/province [67] 0 0
Veszprem Megye
Country [68] 0 0
Italy
State/province [68] 0 0
Ancona
Country [69] 0 0
Italy
State/province [69] 0 0
Avellino
Country [70] 0 0
Italy
State/province [70] 0 0
Latina
Country [71] 0 0
Italy
State/province [71] 0 0
Milano
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Gyeonggi-do
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyunggido
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Jeollabuk-do South Korea
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Busan
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Daegu
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Daejeon
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Incheon
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Watford

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 the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.
Trial website
https://clinicaltrials.gov/study/NCT02045862
Trial related presentations / publications
Gratzke C, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Ridder A, Stoelzel M, Paireddy A, Yoon SJ, Al-Shukri S, Rechberger T, Mueller ER. Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II). Eur Urol. 2018 Oct;74(4):501-509. doi: 10.1016/j.eururo.2018.05.005. Epub 2018 Jun 1.
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/NCT02045862