A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
NCT ID: NCT01908829
Last Updated: 2024-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2174 participants
INTERVENTIONAL
2013-07-10
2014-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Combination (solifenacin + mirabegron)
Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
mirabegron 25 mg
Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
mirabegron 50 mg
Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Solifenacin 5 mg
Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Solifenacin 10 mg
Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
solifenacin 10 mg
Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.
mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
solifenacin 5 mg matching placebo
Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Interventions
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mirabegron 25 mg
Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
mirabegron 50 mg
Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
solifenacin 10 mg
Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.
mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
solifenacin 5 mg matching placebo
Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for \>= 3 months prior to the screening visit
2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
3. Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.
* Main Inclusion at Run-in (Visit 2):
1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.
* Main Inclusion at Randomization (Visit 3):
1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.
Exclusion Criteria
1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
2. Subject has significant Post-void residual (PVR) volume (PVR \> 150 ml).
3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
4. Subject has an indwelling catheter or practices intermittent self catheterization.
5. Subject has evidence of a UTI.
6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
7. Subject has moderate to severe hepatic impairment
8. Subject has severe renal impairment or End Stage Renal disease
9. Subject has a clinically significant abnormal Electrocardiogram (ECG)
10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
11. Subject has a QTcF interval \> 450 ms for males or \> 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
* Main Exclusion at Randomization (visit 3):
1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
2. Subject does not desire an increase in study medication.
3. Subject has an average total daily urine volume \> 3000ml as recorded in the micturition diary.
4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
5. Subject has a clinically significant abnormal ECG
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Genova Clinical Research
Tucson, Arizona, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, United States
The American Institute of Research
Los Angeles, California, United States
Bayview Research Group
Valley Village, California, United States
Meridien Research
Brooksville, Florida, United States
Innovative Research of West FL
Clearwater, Florida, United States
Best Quality Research Inc.
Hialeah, Florida, United States
Palmetto Professional Research
Hialeah, Florida, United States
Urology Center of Central Florida
Kissimmee, Florida, United States
Meridien Research
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Private Practice
West Palm Beach, Florida, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Herman Clinical Research
Suwanee, Georgia, United States
North Idaho Urology
Coeur d'Alene, Idaho, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Deaconess Gateway Health Center
Newburgh, Indiana, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Beyer Research
Kalamazoo, Michigan, United States
Quality Clinical Research
Omaha, Nebraska, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States
Advanced Urology Centers of New York
Garden City, New York, United States
Premier Medical Group of the Hudson Valley PC
Kingston, New York, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States
PMG Research of Raleigh, dba PMG Research of Cary
Cary, North Carolina, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
Wake Research Associates LLC
Raleigh, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Providence Health Partners
Dayton, Ohio, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Jean Brown Research
Salt Lake City, Utah, United States
Alexandria Clinical Research
Alexandria, Virginia, United States
Site: 37402
Yerevan, , Armenia
Site: 37403
Yerevan, , Armenia
Site: 37405
Yerevan, , Armenia
Site: 61006
Adelaide, , Australia
Site: 61001
Kogarah, Sydney, , Australia
Site: 61016
Victoria, , Australia
Site: 43008
Graz, , Austria
Site: 43001
Innsbruck, , Austria
Site: 43006
Innsbruck, , Austria
Site: 43007
Linz, , Austria
Site: 43002
Vienna, , Austria
Site: 43004
Vienna, , Austria
Site: 43005
Vienna, , Austria
Site: 43010
Vienna, , Austria
Site: 43011
Vienna, , Austria
Site: 43012
Vienna, , Austria
Site: 43003
Wels, , Austria
Site: 32007
Anderlecht, , Belgium
Site: 32013
Deurne, , Belgium
Site: 32009
Edegem, , Belgium
Site: 32003
Ghent, , Belgium
Site: 32005
Ghent, , Belgium
Site: 32015
Kortrijk, , Belgium
Site: 32008
Liège, , Belgium
Site: 32014
Roeselare, , Belgium
Site: 15001
Barrie, , Canada
Site: 15009
Bathurst, , Canada
Site: 15006
Brampton, , Canada
Site: 15015
Granby, , Canada
Site: 15014
Kelowna, , Canada
Site: 15007
Kitchener, , Canada
Site: 15019
Sherbrooke, , Canada
Site: 15012
Toronto, , Canada
Site: 15013
Toronto, , Canada
Site: 15016
Victoria, , Canada
Site: 15047
Victoria, , Canada
Site: 15018
Victoriaville, , Canada
Site: 42015
Brno, , Czechia
Site: 42020
Mělník, , Czechia
Site: 42018
Náchod, , Czechia
Site: 42004
Pilsen, , Czechia
Site: 42021
Pilsen, , Czechia
Site: 42007
Prague, , Czechia
Site: 42008
Prague, , Czechia
Site: 42016
Prague, , Czechia
Site: 42017
Prague, , Czechia
Site: 42022
Prague, , Czechia
Site: 45008
Aarhus N, , Denmark
Site: 45003
Frederiksberg, , Denmark
Site: 45009
Herlev, , Denmark
Site: 45011
Odense C, , Denmark
Site: 35804
Helsinki (hus), , Finland
Site: 35805
Tampere, , Finland
Site: 33018
Bordeaux, , France
Site: 33017
Marseille, , France
Site: 99502
T'bilisi, , Georgia
Site: 49008
Bad Ems, , Germany
Site: 49022
Berlin, , Germany
Site: 49003
Eisleben Lutherstadt, , Germany
Site: 49021
Hagenow, , Germany
Site: 49011
Halle, , Germany
Site: 49004
Hamburg, , Germany
Site: 49018
Henningsdorf, , Germany
Site: 49009
Hettstedt, , Germany
Site: 49017
Koblenz, , Germany
Site: 49020
Reutlingen, , Germany
Site: 49014
Sangerhausen, , Germany
Site: 30001
Athens, , Greece
Site: 30005
Heraklion, Crete, , Greece
Site: 30002
Pátrai, , Greece
Site: 36003
Csongrád, , Hungary
Site: 36011
Hajdúszoboszló, , Hungary
Site: 36002
Nyíregyháza, , Hungary
Site: 36008
Salgótarján, , Hungary
Site: 36009
Szekszárd, , Hungary
Site: 35303
Cork, , Ireland
Site: 35301
Dublin, , Ireland
Site: 35309
Dublin, , Ireland
Site: 35310
Dublin, , Ireland
Site: 35306
Limerick, , Ireland
Site: 35313
Mullingar, , Ireland
Site: 35304
Tralee, , Ireland
Site: 35305
Waterford, , Ireland
Site: 97201
Haifa, , Israel
Site: 97202
Jerusalem, , Israel
Site: 97207
Kfar Saba, , Israel
Site: 97203
Petah Tikva, , Israel
Site: 97205
Petah Tikva, , Israel
Site: 97206
Tel Litwinsky, , Israel
Site: 39007
Avellino, , Italy
Site: 39002
Cantanzaro, , Italy
Site: 39010
Florence, , Italy
Site: 39006
Perugia, , Italy
Site: 39013
Treviglio (BG), , Italy
Site: 39009
Varese, , Italy
Site: 96101
Beirut, , Lebanon
Site: 31008
Amsterdam, , Netherlands
Site: 47005
Bekkestua, , Norway
Site: 47003
Trondheim, , Norway
Site: 47002
Tønsberg, , Norway
Site: 48002
Kolbuszowa Dolna, , Poland
Site: 48006
Krakow, , Poland
Site: 48010
Lublin, , Poland
Site: 48005
Piaseczno, , Poland
Site: 48001
Warsaw, , Poland
Site: 48008
Warsaw, , Poland
Site: 35104
Lisbon, , Portugal
Site: 35105
Lisbon, , Portugal
Site: 35102
Matosinhos Municipality, , Portugal
Site: 35103
Porto, , Portugal
Site: 35101
Setúbal, , Portugal
Site: 35106
Tomar, , Portugal
Site: 40016
Bucharest, , Romania
Site: 40018
Bucharest, , Romania
Site: 40012
Craiova, , Romania
Site: 40019
Craiova, , Romania
Site: 40003
Judetul Ilfov, , Romania
Site: 40017
Oradea, , Romania
Site: 40020
Timișoara, , Romania
Site: 70003
Moscow, , Russia
Site: 70004
Moscow, , Russia
Site: 70005
Moscow, , Russia
Site: 70008
Moscow, , Russia
Site: 70010
Moscow, , Russia
Site: 70011
Moscow, , Russia
Site: 70012
Moscow, , Russia
Site: 70024
Moscow, , Russia
Site: 70013
Rostove-on-Don, , Russia
Site: 70002
Saint Petersburg, , Russia
Site: 70006
Saint Petersburg, , Russia
Site: 70007
Saint Petersburg, , Russia
Site: 70009
Saint Petersburg, , Russia
Site: 70025
Saratov, , Russia
Site: 42110
Bratislava, , Slovakia
Site: 42114
Košice, , Slovakia
Site: 42113
Michalovce, , Slovakia
Site: 42111
Nové Zámky, , Slovakia
Site: 42112
Piešťany, , Slovakia
Site: 42108
Poprad, , Slovakia
Site: 42109
Žilina, , Slovakia
Site: 38601
Ljubljana, , Slovenia
Site: 38606
Maribor, , Slovenia
Site: 38607
Maribor, , Slovenia
Site: 38610
Ptuj, , Slovenia
Site: 34012
Barcelona, , Spain
Site: 34016
Bilbao, , Spain
Site: 34013
Donostia / San Sebastian, , Spain
Site: 34001
Getafe (Madrid), , Spain
Site: 34004
Madrid, , Spain
Site: 34015
Madrid, , Spain
Site: 34023
Mendaro, , Spain
Site: 34021
Miranda de Ebro, , Spain
Site: 34018
San Sebastián de los Reyes, , Spain
Site: 34007
Seville, , Spain
Site: 34020
Seville, , Spain
Site: 34014
Vigo, , Spain
Site: 46004
Halmstad, , Sweden
Site: 46013
Lund, , Sweden
Site: 46014
Norrtälje, , Sweden
Site: 46001
Stockholm, , Sweden
Site: 46012
Stockholm, , Sweden
Site: 46015
Umeå, , Sweden
Site: 41008
Baden, , Switzerland
Site: 41001
Frauenfeld, , Switzerland
Site: 90005
Ankara, , Turkey (Türkiye)
Site: 90008
Ankara, , Turkey (Türkiye)
Site: 90002
Izmir, , Turkey (Türkiye)
Site: 90003
Izmir, , Turkey (Türkiye)
Site: 90007
Kocaeli, , Turkey (Türkiye)
Site: 90004
Manisa, , Turkey (Türkiye)
Site: 90006
Sivas, , Turkey (Türkiye)
Site: 44007
Bristol, , United Kingdom
Site: 44012
Cambridge, , United Kingdom
Site: 44015
Cheltenham, , United Kingdom
Site: 44019
Coventry, , United Kingdom
Site: 44009
Garston, , United Kingdom
Site: 44016
Kings Lynn, , United Kingdom
Site: 44017
London, , United Kingdom
Site: 44018
Northampton, , United Kingdom
Site: 44010
Nottingham, , United Kingdom
Site: 44008
Plymouth, , United Kingdom
Site: 44013
Taunton, , United Kingdom
Site: 44011
West Yorkshire, , United Kingdom
Countries
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References
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Gibson W, MacDiarmid S, Huang M, Siddiqui E, Stolzel M, Choudhury N, Drake MJ. Treating Overactive Bladder in Older Patients with a Combination of Mirabegron and Solifenacin: A Prespecified Analysis from the BESIDE Study. Eur Urol Focus. 2017 Dec;3(6):629-638. doi: 10.1016/j.euf.2017.08.008. Epub 2017 Sep 12.
Drake MJ, Chapple C, Esen AA, Athanasiou S, Cambronero J, Mitcheson D, Herschorn S, Saleem T, Huang M, Siddiqui E, Stolzel M, Herholdt C, MacDiarmid S; BESIDE study investigators. Efficacy and Safety of Mirabegron Add-on Therapy to Solifenacin in Incontinent Overactive Bladder Patients with an Inadequate Response to Initial 4-Week Solifenacin Monotherapy: A Randomised Double-blind Multicentre Phase 3B Study (BESIDE). Eur Urol. 2016 Jul;70(1):136-145. doi: 10.1016/j.eururo.2016.02.030. Epub 2016 Mar 8.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2012-005401-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-EC-012
Identifier Type: -
Identifier Source: org_study_id
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