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Clinical TrialID 5339

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

NCT02045862

Urinary Bladder Overactive|Overactive Bladder|Urgency Incontinence|Urinary Bladder Diseases\Urologic Diseases

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Record Fields

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Clinical Trial Id
5339
Evidence Id
5339
Core Evidence Id
5339
Source Clinical Trial Id
5325
Herb2 Clinical Trial Id
HBCT005325
Nct Id
NCT02045862
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
Status
Completed
Phase
Phase 3
Study Result
Yes
Study Condition
Urinary Bladder Overactive|Overactive Bladder|Urgency Incontinence|Urinary Bladder Diseases\Urologic Diseases
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Solifenacin succinate|DRUG: Mirabegron|DRUG: Placebo to match solifenacin|DRUG: Placebo to match mirabegron
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
1829
Outcome Measure
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities)., From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours, 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 in a micturition diary for 7 days prior to the baseline and week 52 clinic visits., Baseline and Week 52|Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours, A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits., Baseline and Week 52
Sponsor Collaborator
Astellas Pharma Europe B.V.
Funded By
INDUSTRY
Location
Site US10049, Mobile, Alabama, 36608, United States|Site US10112, Mobile, Alabama, 36608, United States|Site US10104, Chandler, Arizona, 85224, United States|Site US10021, Phoenix, Arizona, 85051, United States|Site US10122, Anaheim, California, 92801, United States|Site US10082, Hawaiian Gardens, California, 90716, United States|Site US10132, Los Angeles, California, 90017, United States|Site US10133, Los Angeles, California, 90036, United States|Site US10149, Paramount, California, 90723, United States|Site US10003, San Diego, California, 92120, United States|Site US10106, Tarzana, California, 91356, United States|Site US10595, Valley Village, California, 91607, United States|Site US10053, Wheat Ridge, Colorado, 80033, United States|Site US10060, Bradenton, Florida, 34208, United States|Site US10097, Hialeah, Florida, 33012, United States|Site US10148, Hialeah, Florida, 33016, United States|Site US10153, Hialeah, Florida, 33016, United States|Site US10091, Jupiter, Florida, 33458, United States|Site US10150, New Port Richey, Florida, 34652, United States|Site US10124, Orlando, Florida, 32803, United States|Site US10134, Orlando, Florida, 32806, United States|Site US10009, Pembroke Pines, Florida, 33027, United States|Site US10554, Plantation, Florida, 33317, United States|Site US10037, Alpharetta, Georgia, 30005, United States|Site US10127, Roswell, Georgia, 30076, United States|Site US10120, Sandy Springs, Georgia, 30328, United States|Site US10078, Wichita, Kansas, 67205, United States|Site US10088, Lake Charles, Louisiana, 70601, United States|Site US10025, Shreveport, Louisiana, 71106, United States|Site US10558, Hanover, Maryland, 21076, United States|Site US10282, Boston, Massachusetts, 02131, United States|Site US10114, Watertown, Massachusetts, 02472, United States|Site US10110, Billings, Montana, 59102, United States|Site US10154, Missoula, Montana, 59801, United States|Site US10553, Lincoln, Nebraska, 68510, United States|Site US10002, Englewood, New Jersey, 07631, United States|Site US10047, Lawrenceville, New Jersey, 08648, United States|Site US10011, Albuquerque, New Mexico, 87102, United States|Site US10015, Albuquerque, New Mexico, 87109, United States|Site US10026, Garden City, New York, 11530, United States|Site US10040, Kingston, New York, 12401, United States|Site US10168, New York, New York, 10065, United States|Site US10126, Newburgh, New York, 12550, United States|Site US10028, Poughkeepsie, New York, 12601, United States|Site US10076, Concord, North Carolina, 28025, United States|Site US10129, Raleigh, North Carolina, 27609, United States|Site US10062, Winston-Salem, North Carolina, 27103, United States|Site US10050, Cleveland, Ohio, 44122, United States|Site US10067, Wadsworth, Ohio, 44281, United States|Site US10109, Oklahoma City, Oklahoma, 73112, United States|Site US10541, Medford, Oregon, 97504, United States|Site US10008, Bala-Cynwyd, Pennsylvania, 19004, United States|Site US10017, Philadelphia, Pennsylvania, 19114, United States|Site US10167, Pittsburgh, Pennsylvania, 15213, United States|Site US10250, Pittsburgh, Pennsylvania, 15236, United States|Site US10248, Pittsburgh, Pennsylvania, 15243, United States|Site US10063, Uniontown, Pennsylvania, 15401, United States|Site US10012, West Reading, Pennsylvania, 19611, United States|Site US10166, Charleston, South Carolina, 29425, United States|Site US10079, Mount Pleasant, South Carolina, 29464, United States|Site US10023, Simpsonville, South Carolina, 29681, United States|Site US10101, Summerville, South Carolina, 29485, United States|Site US10006, Kingsport, Tennessee, 37660, United States|Site US10065, Corpus Christi, Texas, 78414, United States|Site US10085, Houston, Texas, 77058, United States|Site US10219, Houston, Texas, 77094, United States|Site US10093, Houston, Texas, 77099, United States|Site US10090, Hurst, Texas, 76054, United States|Site US10105, San Antonio, Texas, 78229, United States|Site US10111, San Antonio, Texas, 78229, United States|Site US10083, Virginia Beach, Virginia, 23462, United States|Site US10013, Burien, Washington, 98166, United States|Site US10004, Mountlake Terrace, Washington, 98043, United States|Site US10155, Seattle, Washington, 98105, United States|Site US10135, Walla Walla, Washington, 99362, United States|Site AU61005, Broadmeadow, New South Wales, 2292, Australia|Site AU61007, Randwick, New South Wales, 2031, Australia|Site AU61021, Randwick, New South Wales, 2031, Australia|Site AU61011, Wollongong, New South Wales, 2522, Australia|Site AU61022, Brisbane, Queensland, 4152, Australia|Site AU61010, Nambour, Queensland, 4560, Australia|Site AU61019, Sherwood, Queensland, 4075, Australia|Site AU61015, Daw Park, South Australia, 5041, Australia|Site AU61025, Footscray, Victoria, 3011, Australia|Site AU61002, Parkville, Victoria, 3052, Australia|Site AU61004, Perth, Western Australia, 6009, Australia|Site BE32004, Gent, 9000, Belgium|Site BE32014, Roeselare, 8800, Belgium|Site BE32012, Sint-Truiden, 3800, Belgium|Site BG35908, Plovdiv, 4003, Bulgaria|Site BG35902, Ruse, 7000, Bulgaria|Site BG35905, Sofia, 1431, Bulgaria|Site BG35903, Sofia, 1606, Bulgaria|Site CA15035, Edmonton, Alberta, T5G 0B7, Canada|Site CA15033, Vancouver, British Columbia, V5Z 4E1, Canada|Site CA15008, Saint John, New Brunswick, E2L 3J8, Canada|Site CA15001, Barrie, Ontario, L4M 7G1, Canada|Site CA15006, Brampton, Ontario, L6T 4S5, Canada|Site CA15003, Brantford, Ontario, N3S 6T6, Canada|Site CA15007, Kitchener, Ontario, N2N 2B9, Canada|Site CA15013, Toronto, Ontario, M4N 3M5, Canada|Site CA15004, Toronto, Ontario, M4S 1Y2, Canada|Site CA15026, Drummondville, Quebec, J2B 7T1, Canada|Site CA15039, Levis, Quebec, G6W 5M6, Canada|Site CA15020, Montreal, Quebec, H4N 3C5, Canada|Site CA15027, Sherbrooke, Quebec, J1H 1Z1, Canada|Site CA15040, Montreal, H2R 1V6, Canada|Site CA15025, Quebec, G1S 2L6, Canada|Site CZ42015, Brno, 602 00, Czechia|Site CZ42003, Hradec Kralove, 500 02, Czechia|Site CZ42001, Hradec Kralove, 50005, Czechia|Site CZ42010, Olomouc, 772 00, Czechia|Site CZ42014, Ostrava, 700 30, Czechia|Site CZ42005, Plzen, 32600, Czechia|Site CZ42008, Praha 2, 12808, Czechia|Site CZ42007, Praha 4, 140 00, Czechia|Site CZ42013, Sternberk, 78501, Czechia|Site CZ42009, Uherske Hradiste, 686 08, Czechia|Site CZ42006, Usti nad Labem, 40001, Czechia|Site DK45013, Aarhus, 8200, Denmark|Site EE37201, Parnu, 80010, Estonia|Site FI35801, Kouvola, 45200, Finland|Site DE49034, Munich, Bavaria, 81377, Germany|Site DE49031, Bergisch Gladbach, Northwest, 51427, Germany|Site DE49032, Duisburg, NRW, 47179, Germany|Site DE49003, Lutherstadt Eisleben, Sachsen Anhalt, 06295, Germany|Site DE49013, Leipzig, Sachsen, 04105, Germany|Site DE49008, Bad Ems, 56130, Germany|Site DE49002, Duisburg, 47051, Germany|Site DE49010, Ganderkesee, 27777, Germany|Site DE49011, Halle (Saale), 06132, Germany|Site DE49001, Neustadt I. Sachsen, 01844, Germany|Site DE49026, Rostock, 18107, Germany|Site DE49014, Sangerhausen, 06526, Germany|Site HU36007, Kecskemet, Bacs-Kiskun Megye, 6000, Hungary|Site HU36005, Pecs, Baranya Megye, 7621, Hungary|Site HU36003, Csongrad, Csongrad Megye, 6640, Hungary|Site HU36001, Szentes, Csongrad Megye, 6600, Hungary|Site HU36013, Sopron, Gyor-Moson Sopron, 9400, Hungary|Site HU36012, Veszprem, Veszprem Megye, 8200, Hungary|Site IT39022, Ancona, 60126, Italy|Site IT39007, Avellino, 83100, Italy|Site IT39001, Latina, 04100, Italy|Site IT39020, Milano, 20100, Italy|Site KR82004, Suwon-si, Gyeonggi-do, 443-721, Korea, Republic of|Site KR82014, Bucheon-Si, Gyunggido, 420-767, Korea, Republic of|Site KR82012, Seoul, Gyunggido, 143-729, Korea, Republic of|Site KR82010, Jeonju-si, Jeollabuk-do South Korea, 561-712, Korea, Republic of|Site KR82006, Busan, 602-715, Korea, Republic of|Site KR82016, Busan, 602-739, Korea, Republic of|Site KR82005, Daegu, 705-717, Korea, Republic of|Site KR82029, Daegu, 705-718, Korea, Republic of|Site KR82019, Daejeon, 301-721, Korea, Republic of|Site KR82023, Incheon, 405760, Korea, Republic of|Site KR82003, Seoul, 05505, Korea, Republic of|Site KR82021, Seoul, 100-380, Korea, Republic of|Site KR82020, Seoul, 110-744, Korea, Republic of|Site KR82030, Seoul, 120-752, Korea, Republic of|Site KR82013, Seoul, 134-701, Korea, Republic of|Site KR82017, Seoul, 134-872, Korea, Republic of|Site KR82002, Seoul, 135-710, Korea, Republic of|Site KR82008, Seoul, 135-720, Korea, Republic of|Site KR82015, Seoul, 136-075, Korea, Republic of|Site KR82001, Seoul, 137-701, Korea, Republic of|Site LV37102, Liepaja, LV-3401, Latvia|Site LV37103, Olaine, LV-2114, Latvia|Site LV37105, Riga, LV-1002, Latvia|Site LT37008, Kaunas, 47144, Lithuania|Site LT37004, Kaunas, 50009, Lithuania|Site LT37011, Kaunas, LT49449, Lithuania|Site LT37012, Klaipeda, LT-92288, Lithuania|Site LT37010, Vilnius, 10207, Lithuania|Site LT37003, Vilnius, LT-01118, Lithuania|Site LT37007, Vilnius, LT-08661, Lithuania|Site LT37009, Vilnius, LT-09108, Lithuania|Site MY60002, Petaling Jaya, 47500, Malaysia|Site MX52003, Mexico City, DF, 06700, Mexico|Site NL31006, Enschede, NL, 7513ER, Netherlands|Site NL31002, Amsterdam, 1105 AZ, Netherlands|Site NL31005, Nijmegen, 6532 SZ, Netherlands|Site NL31010, Sneek, 8601 ZK, Netherlands|Site NZ64001, Christchurch, Canterbury, 8013, New Zealand|Site NZ64002, Nelson, 7010, New Zealand|Site NZ64003, Tauranga, 3140, New Zealand|Site NZ64006, Whangarei, 0112, New Zealand|Site NO47007, Alesund, 6003, Norway|Site NO47006, Hamar, 2317, Norway|Site NO47008, Lierskogen, 3420, Norway|Site PL48018, Bialystok, 15-351, Poland|Site PL48013, Chorzow, 41-500, Poland|Site PL48014, Gdynia, 81-384, Poland|Site PL48004, Lodz, 90-302, Poland|Site PL48010, Lublin, 20-632, Poland|Site PL48011, Myslowice, 41-400, Poland|Site PL48016, Opole, 45-086, Poland|Site PL48005, Piaseczno, 05-500, Poland|Site PL48012, Warsaw, 00-909, Poland|Site PL48003, Warszawa, 02-507, Poland|Site PL48001, Warszawa, 02-929, Poland|Site PL48019, Wrocław, 50-088, Poland|Site RO40014, Cluj-Napoca, Cluj, 400046, Romania|Site RO40004, Bucuresti, 042122, Romania|Site RO40001, Bucuresti, 50659, Romania|Site RO40005, Bucuresti, 50659, Romania|Site RO40010, Sibiu, 550245, Romania|Site RO40002, Timisoara, 300736, Romania|Site RU70015, Kazan, 420097, Russian Federation|Site RU70023, Penza, 440026, Russian Federation|Site RU70019, Saint Petersburg, 194354, Russian Federation|Site RU70002, Saint Petersburg, 197089, Russian Federation|Site RU70022, Saint Petersburg, 198103, Russian Federation|Site RU70014, St. Petersburg, 199178, Russian Federation|Site RU70018, Ufa, 450096, Russian Federation|Site SG65002, Singapore, 169608, Singapore|Site SG65003, Singapore, 229899, Singapore|Site SK42105, Bratislava, 82101, Slovakia|Site SK42107, Kosice, 04001, Slovakia|Site SK42101, Kosice, 04013, Slovakia|Site SK42103, Nitra, 949 01, Slovakia|Site SK42108, Poprad, 05801, Slovakia|Site SK42104, Prešov, 080 01, Slovakia|Site SK42102, Trencin, 91101, Slovakia|Site SK42106, Trencin, 91101, Slovakia|Site SI38604, Murska Sobota, 9000, Slovenia|Site ZA27001, Centurion, Gauteng, 0157, South Africa|Site ZA27002, Roodepoort, Gauteng, 1709, South Africa|Site ZA27006, Durban, Kwa Zulu Natal, 4001, South Africa|Site ZA27013, Meyerspark, Pretoria, 0184, South Africa|Site ZA27007, Paarl, Western Cape, 7646, South Africa|Site ES34004, Madrid, 28031, Spain|Site ES34015, Madrid, 28044, Spain|Site ES34009, Madrid, 28046, Spain|Site ES34002, Valencia, 46026, Spain|Site SE46007, Boras, 506 30, Sweden|Site SE46005, Malmo, 211 52, Sweden|Site SE46016, Stockholm, 111 57, Sweden|Site SE46012, Stockholm, 141 86, Sweden|Site SE46003, Stockholm, 182 88, Sweden|Site SE46009, Uppsala, 753 19, Sweden|Site TH66008, Bangkok, 10400, Thailand|Site TH66009, Khon Kaen, 40002, Thailand|Site UA38002, Cherenigiv, 14034, Ukraine|Site UA38015, Chernivtsi, 58002, Ukraine|Site UA38013, Dnepropetrovsk, 49005, Ukraine|Site UA38007, Kiev, 02232, Ukraine|Site UA38003, Kyiv, 02660, Ukraine|Site UA38010, Kyiv, 04053, Ukraine|Site UA38008, Zaporizhzhya, 69600, Ukraine|Site GB44001, Sheffield, South Yorkshire, S10 2JF, United Kingdom|Site GB44006, Plymouth, PL6 8DH, United Kingdom|Site GB44009, Watford, WD25 7NL, United Kingdom
Other Id
178-CL-102|2012-005736-29
Start Date
2014-03-17
Primary Completion Date
2016-09-08
Completion Date
2016-09-08
First Posted
2014-01-27
Results First Posted
2018-06-06
Last Update Posted
2018-09-13
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02045862
Title Cn
Title En
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
Bilingual Status
semi_complete