Clinical trial NCT02045862: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder Overactive
Overactive Bladder
Urgency Incontinence
Urinary Bladder Diseases\Urologic Diseases
Keywords: Solifenacin Succinate
Mirabegron
Urinary Incontinence
Combination Therapy
Urgency
Nocturia
Overactive Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 1829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
measure: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 52
measure: Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Change From Baseline to EoT in Mean Volume Voided Per Micturition
timeFrame: Baseline and Week 52
measure: Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
timeFrame: Baseline and Week 52
measure: Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
timeFrame: Baseline and Week 52
measure: Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
timeFrame: Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
timeFrame: Months 1, 3, 6, 9, 12
measure: Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
timeFrame: Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
timeFrame: Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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)
timeFrame: Months 1, 3, 6, 9, 12
measure: Change From Baseline to EoT in Corrected Micturition Frequency
timeFrame: Baseline and Month 12
measure: Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
timeFrame: Baseline and Months 3, 6, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
timeFrame: Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
timeFrame: Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
timeFrame: Month 12
measure: Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
timeFrame: Month 12
measure: Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
timeFrame: Baseline and 12 Months
measure: Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
timeFrame: Baseline and Month 12
measure: Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
timeFrame: Baseline and Month 12
measure: Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
timeFrame: Baseline and Month 12
measure: Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
timeFrame: Baseline and Month 12
measure: 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
timeFrame: Baseline and Months 6,12
measure: Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
timeFrame: Baseline and Months 6, 12
measure: Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
timeFrame: Baseline and Months 6, 12
measure: Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
timeFrame: Baseline and Months 6, 12
measure: 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
timeFrame: Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Months 1, 3, 6, 9, 12
measure: Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: 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
timeFrame: Baseline and Months 1, 3, 6, 9, 12
measure: Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
timeFrame: Baseline and Months 1, 3, 6, 9, 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Site US10049
state: Alabama
city: Mobile
country: United States
facility: Site US10112
state: Alabama
city: Chandler
country: United States
facility: Site US10104
state: Arizona
city: Phoenix
country: United States
facility: Site US10021
state: Arizona
city: Anaheim
country: United States
facility: Site US10122
state: California
city: Hawaiian Gardens
country: United States
facility: Site US10082
state: California
city: Los Angeles
country: United States
facility: Site US10132
state: California
city: Los Angeles
country: United States
facility: Site US10133
state: California
city: Paramount
country: United States
facility: Site US10149
state: California
city: San Diego
country: United States
facility: Site US10003
state: California
city: Tarzana
country: United States
facility: Site US10106
state: California
city: Valley Village
country: United States
facility: Site US10595
state: California
city: Wheat Ridge
country: United States
facility: Site US10053
state: Colorado
city: Bradenton
country: United States
facility: Site US10060
state: Florida
city: Hialeah
country: United States
facility: Site US10097
state: Florida
city: Hialeah
country: United States
facility: Site US10148
state: Florida
city: Hialeah
country: United States
facility: Site US10153
state: Florida
city: Jupiter
country: United States
facility: Site US10091
state: Florida
city: New Port Richey
country: United States
facility: Site US10150
state: Florida
city: Orlando
country: United States
facility: Site US10124
state: Florida
city: Orlando
country: United States
facility: Site US10134
state: Florida
city: Pembroke Pines
country: United States
facility: Site US10009
state: Florida
city: Plantation
country: United States
facility: Site US10554
state: Florida
city: Alpharetta
country: United States
facility: Site US10037
state: Georgia
city: Roswell
country: United States
facility: Site US10127
state: Georgia
city: Sandy Springs
country: United States
facility: Site US10120
state: Georgia
city: Wichita
country: United States
facility: Site US10078
state: Kansas
city: Lake Charles
country: United States
facility: Site US10088
state: Louisiana
city: Shreveport
country: United States
facility: Site US10025
state: Louisiana
city: Hanover
country: United States
facility: Site US10558
state: Maryland
city: Boston
country: United States
facility: Site US10282
state: Massachusetts
city: Watertown
country: United States
facility: Site US10114
state: Massachusetts
city: Billings
country: United States
facility: Site US10110
state: Montana
city: Missoula
country: United States
facility: Site US10154
state: Montana
city: Lincoln
country: United States
facility: Site US10553
state: Nebraska
city: Englewood
country: United States
facility: Site US10002
state: New Jersey
city: Lawrenceville
country: United States
facility: Site US10047
state: New Jersey
city: Albuquerque
country: United States
facility: Site US10011
state: New Mexico
city: Albuquerque
country: United States
facility: Site US10015
state: New Mexico
city: Garden City
country: United States
facility: Site US10026
state: New York
city: Kingston
country: United States
facility: Site US10040
state: New York
city: New York
country: United States
facility: Site US10168
state: New York
city: Newburgh
country: United States
facility: Site US10126
state: New York
city: Poughkeepsie
country: United States
facility: Site US10028
state: New York
city: Concord
country: United States
facility: Site US10076
state: North Carolina
city: Raleigh
country: United States
facility: Site US10129
state: North Carolina
city: Winston-Salem
country: United States
facility: Site US10062
state: North Carolina
city: Cleveland
country: United States
facility: Site US10050
state: Ohio
city: Wadsworth
country: United States
facility: Site US10067
state: Ohio
city: Oklahoma City
country: United States
facility: Site US10109
state: Oklahoma
city: Medford
country: United States
facility: Site US10541
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Site US10008
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site US10017
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US10167
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US10250
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US10248
state: Pennsylvania
city: Uniontown
country: United States
facility: Site US10063
state: Pennsylvania
city: West Reading
country: United States
facility: Site US10012
state: Pennsylvania
city: Charleston
country: United States
facility: Site US10166
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site US10079
state: South Carolina
city: Simpsonville
country: United States
facility: Site US10023
state: South Carolina
city: Summerville
country: United States
facility: Site US10101
state: South Carolina
city: Kingsport
country: United States
facility: Site US10006
state: Tennessee
city: Corpus Christi
country: United States
facility: Site US10065
state: Texas
city: Houston
country: United States
facility: Site US10085
state: Texas
city: Houston
country: United States
facility: Site US10219
state: Texas
city: Houston
country: United States
facility: Site US10093
state: Texas
city: Hurst
country: United States
facility: Site US10090
state: Texas
city: San Antonio
country: United States
facility: Site US10105
state: Texas
city: San Antonio
country: United States
facility: Site US10111
state: Texas
city: Virginia Beach
country: United States
facility: Site US10083
state: Virginia
city: Burien
country: United States
facility: Site US10013
state: Washington
city: Mountlake Terrace
country: United States
facility: Site US10004
state: Washington
city: Seattle
country: United States
facility: Site US10155
state: Washington
city: Walla Walla
country: United States
facility: Site US10135
state: Washington
city: Broadmeadow
country: Australia
facility: Site AU61005
state: New South Wales
city: Randwick
country: Australia
facility: Site AU61007
state: New South Wales
city: Randwick
country: Australia
facility: Site AU61021
state: New South Wales
city: Wollongong
country: Australia
facility: Site AU61011
state: New South Wales
city: Brisbane
country: Australia
facility: Site AU61022
state: Queensland
city: Nambour
country: Australia
facility: Site AU61010
state: Queensland
city: Sherwood
country: Australia
facility: Site AU61019
state: Queensland
city: Daw Park
country: Australia
facility: Site AU61015
state: South Australia
city: Footscray
country: Australia
facility: Site AU61025
state: Victoria
city: Parkville
country: Australia
facility: Site AU61002
state: Victoria
city: Perth
country: Australia
facility: Site AU61004
state: Western Australia
city: Gent
country: Belgium
facility: Site BE32004
city: Roeselare
country: Belgium
facility: Site BE32014
city: Sint-Truiden
country: Belgium
facility: Site BE32012
city: Plovdiv
country: Bulgaria
facility: Site BG35908
city: Ruse
country: Bulgaria
facility: Site BG35902
city: Sofia
country: Bulgaria
facility: Site BG35905
city: Sofia
country: Bulgaria
facility: Site BG35903
city: Edmonton
country: Canada
facility: Site CA15035
state: Alberta
city: Vancouver
country: Canada
facility: Site CA15033
state: British Columbia
city: Saint John
country: Canada
facility: Site CA15008
state: New Brunswick
city: Barrie
country: Canada
facility: Site CA15001
state: Ontario
city: Brampton
country: Canada
facility: Site CA15006
state: Ontario
city: Brantford
country: Canada
facility: Site CA15003
state: Ontario
city: Kitchener
country: Canada
facility: Site CA15007
state: Ontario
city: Toronto
country: Canada
facility: Site CA15013
state: Ontario
city: Toronto
country: Canada
facility: Site CA15004
state: Ontario
city: Drummondville
country: Canada
facility: Site CA15026
state: Quebec
city: Levis
country: Canada
facility: Site CA15039
state: Quebec
city: Montreal
country: Canada
facility: Site CA15020
state: Quebec
city: Sherbrooke
country: Canada
facility: Site CA15027
state: Quebec
city: Montreal
country: Canada
facility: Site CA15040
city: Quebec
country: Canada
facility: Site CA15025
city: Brno
country: Czechia
facility: Site CZ42015
city: Hradec Kralove
country: Czechia
facility: Site CZ42003
city: Hradec Kralove
country: Czechia
facility: Site CZ42001
city: Olomouc
country: Czechia
facility: Site CZ42010
city: Ostrava
country: Czechia
facility: Site CZ42014
city: Plzen
country: Czechia
facility: Site CZ42005
city: Praha 2
country: Czechia
facility: Site CZ42008
city: Praha 4
country: Czechia
facility: Site CZ42007
city: Sternberk
country: Czechia
facility: Site CZ42013
city: Uherske Hradiste
country: Czechia
facility: Site CZ42009
city: Usti nad Labem
country: Czechia
facility: Site CZ42006
city: Aarhus
country: Denmark
facility: Site DK45013
city: Parnu
country: Estonia
facility: Site EE37201
city: Kouvola
country: Finland
facility: Site FI35801
city: Munich
country: Germany
facility: Site DE49034
state: Bavaria
city: Bergisch Gladbach
country: Germany
facility: Site DE49031
state: Northwest
city: Duisburg
country: Germany
facility: Site DE49032
state: NRW
city: Lutherstadt Eisleben
country: Germany
facility: Site DE49003
state: Sachsen Anhalt
city: Leipzig
country: Germany
facility: Site DE49013
state: Sachsen
city: Bad Ems
country: Germany
facility: Site DE49008
city: Duisburg
country: Germany
facility: Site DE49002
city: Ganderkesee
country: Germany
facility: Site DE49010
city: Halle (Saale)
country: Germany
facility: Site DE49011
city: Neustadt I. Sachsen
country: Germany
facility: Site DE49001
city: Rostock
country: Germany
facility: Site DE49026
city: Sangerhausen
country: Germany
facility: Site DE49014
city: Kecskemet
country: Hungary
facility: Site HU36007
state: Bacs-Kiskun Megye
city: Pecs
country: Hungary
facility: Site HU36005
state: Baranya Megye
city: Csongrad
country: Hungary
facility: Site HU36003
state: Csongrad Megye
city: Szentes
country: Hungary
facility: Site HU36001
state: Csongrad Megye
city: Sopron
country: Hungary
facility: Site HU36013
state: Gyor-Moson Sopron
city: Veszprem
country: Hungary
facility: Site HU36012
state: Veszprem Megye
city: Ancona
country: Italy
facility: Site IT39022
city: Avellino
country: Italy
facility: Site IT39007
city: Latina
country: Italy
facility: Site IT39001
city: Milano
country: Italy
facility: Site IT39020
city: Suwon-si
country: Korea, Republic of
facility: Site KR82004
state: Gyeonggi-do
city: Bucheon-Si
country: Korea, Republic of
facility: Site KR82014
state: Gyunggido
city: Seoul
country: Korea, Republic of
facility: Site KR82012
state: Gyunggido
city: Jeonju-si
country: Korea, Republic of
facility: Site KR82010
state: Jeollabuk-do South Korea
city: Busan
country: Korea, Republic of
facility: Site KR82006
city: Busan
country: Korea, Republic of
facility: Site KR82016
city: Daegu
country: Korea, Republic of
facility: Site KR82005
city: Daegu
country: Korea, Republic of
facility: Site KR82029
city: Daejeon
country: Korea, Republic of
facility: Site KR82019
city: Incheon
country: Korea, Republic of
facility: Site KR82023
city: Seoul
country: Korea, Republic of
facility: Site KR82003
city: Seoul
country: Korea, Republic of
facility: Site KR82021
city: Seoul
country: Korea, Republic of
facility: Site KR82020
city: Seoul
country: Korea, Republic of
facility: Site KR82030
city: Seoul
country: Korea, Republic of
facility: Site KR82013
city: Seoul
country: Korea, Republic of
facility: Site KR82017
city: Seoul
country: Korea, Republic of
facility: Site KR82002
city: Seoul
country: Korea, Republic of
facility: Site KR82008
city: Seoul
country: Korea, Republic of
facility: Site KR82015
city: Seoul
country: Korea, Republic of
facility: Site KR82001
city: Liepaja
country: Latvia
facility: Site LV37102
city: Olaine
country: Latvia
facility: Site LV37103
city: Riga
country: Latvia
facility: Site LV37105
city: Kaunas
country: Lithuania
facility: Site LT37008
city: Kaunas
country: Lithuania
facility: Site LT37004
city: Kaunas
country: Lithuania
facility: Site LT37011
city: Klaipeda
country: Lithuania
facility: Site LT37012
city: Vilnius
country: Lithuania
facility: Site LT37010
city: Vilnius
country: Lithuania
facility: Site LT37003
city: Vilnius
country: Lithuania
facility: Site LT37007
city: Vilnius
country: Lithuania
facility: Site LT37009
city: Petaling Jaya
country: Malaysia
facility: Site MY60002
city: Mexico City
country: Mexico
facility: Site MX52003
state: DF
city: Enschede
country: Netherlands
facility: Site NL31006
state: NL
city: Amsterdam
country: Netherlands
facility: Site NL31002
city: Nijmegen
country: Netherlands
facility: Site NL31005
city: Sneek
country: Netherlands
facility: Site NL31010
city: Christchurch
country: New Zealand
facility: Site NZ64001
state: Canterbury
city: Nelson
country: New Zealand
facility: Site NZ64002
city: Tauranga
country: New Zealand
facility: Site NZ64003
city: Whangarei
country: New Zealand
facility: Site NZ64006
city: Alesund
country: Norway
facility: Site NO47007
city: Hamar
country: Norway
facility: Site NO47006
city: Lierskogen
country: Norway
facility: Site NO47008
city: Bialystok
country: Poland
facility: Site PL48018
city: Chorzow
country: Poland
facility: Site PL48013
city: Gdynia
country: Poland
facility: Site PL48014
city: Lodz
country: Poland
facility: Site PL48004
city: Lublin
country: Poland
facility: Site PL48010
city: Myslowice
country: Poland
facility: Site PL48011
city: Opole
country: Poland
facility: Site PL48016
city: Piaseczno
country: Poland
facility: Site PL48005
city: Warsaw
country: Poland
facility: Site PL48012
city: Warszawa
country: Poland
facility: Site PL48003
city: Warszawa
country: Poland
facility: Site PL48001
city: Wrocław
country: Poland
facility: Site PL48019
city: Cluj-Napoca
country: Romania
facility: Site RO40014
state: Cluj
city: Bucuresti
country: Romania
facility: Site RO40004
city: Bucuresti
country: Romania
facility: Site RO40001
city: Bucuresti
country: Romania
facility: Site RO40005
city: Sibiu
country: Romania
facility: Site RO40010
city: Timisoara
country: Romania
facility: Site RO40002
city: Kazan
country: Russian Federation
facility: Site RU70015
city: Penza
country: Russian Federation
facility: Site RU70023
city: Saint Petersburg
country: Russian Federation
facility: Site RU70019
city: Saint Petersburg
country: Russian Federation
facility: Site RU70002
city: Saint Petersburg
country: Russian Federation
facility: Site RU70022
city: St. Petersburg
country: Russian Federation
facility: Site RU70014
city: Ufa
country: Russian Federation
facility: Site RU70018
city: Singapore
country: Singapore
facility: Site SG65002
city: Singapore
country: Singapore
facility: Site SG65003
city: Bratislava
country: Slovakia
facility: Site SK42105
city: Kosice
country: Slovakia
facility: Site SK42107
city: Kosice
country: Slovakia
facility: Site SK42101
city: Nitra
country: Slovakia
facility: Site SK42103
city: Poprad
country: Slovakia
facility: Site SK42108
city: Prešov
country: Slovakia
facility: Site SK42104
city: Trencin
country: Slovakia
facility: Site SK42102
city: Trencin
country: Slovakia
facility: Site SK42106
city: Murska Sobota
country: Slovenia
facility: Site SI38604
city: Centurion
country: South Africa
facility: Site ZA27001
state: Gauteng
city: Roodepoort
country: South Africa
facility: Site ZA27002
state: Gauteng
city: Durban
country: South Africa
facility: Site ZA27006
state: Kwa Zulu Natal
city: Meyerspark
country: South Africa
facility: Site ZA27013
state: Pretoria
city: Paarl
country: South Africa
facility: Site ZA27007
state: Western Cape
city: Madrid
country: Spain
facility: Site ES34004
city: Madrid
country: Spain
facility: Site ES34015
city: Madrid
country: Spain
facility: Site ES34009
city: Valencia
country: Spain
facility: Site ES34002
city: Boras
country: Sweden
facility: Site SE46007
city: Malmo
country: Sweden
facility: Site SE46005
city: Stockholm
country: Sweden
facility: Site SE46016
city: Stockholm
country: Sweden
facility: Site SE46012
city: Stockholm
country: Sweden
facility: Site SE46003
city: Uppsala
country: Sweden
facility: Site SE46009
city: Bangkok
country: Thailand
facility: Site TH66008
city: Khon Kaen
country: Thailand
facility: Site TH66009
city: Cherenigiv
country: Ukraine
facility: Site UA38002
city: Chernivtsi
country: Ukraine
facility: Site UA38015
city: Dnepropetrovsk
country: Ukraine
facility: Site UA38013
city: Kiev
country: Ukraine
facility: Site UA38007
city: Kyiv
country: Ukraine
facility: Site UA38003
city: Kyiv
country: Ukraine
facility: Site UA38010
city: Zaporizhzhya
country: Ukraine
facility: Site UA38008
city: Sheffield
country: United Kingdom
facility: Site GB44001
state: South Yorkshire
city: Plymouth
country: United Kingdom
facility: Site GB44006
city: Watford
country: United Kingdom
facility: Site GB44009
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.