Search / Trial NCT01972841

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
Launched by ASTELLAS PHARMA EUROPE B.V. · Oct 25, 2013

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Trial Information

Current as of April 25, 2025

Completed

Keywords

Combination Therapy Mirabegron Overactive Bladder Urgency Urinary Incontinence Nocturia Solifenacin Succinate

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

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;
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.

About Astellas Pharma Europe B.V.

Astellas Pharma Europe B.V. is a European affiliate of Astellas Pharma Inc., a global pharmaceutical company dedicated to improving the health of patients worldwide through innovative medicines. With a strong focus on urology, oncology, immunology, and neuroscience, Astellas is committed to advancing therapeutic solutions that address unmet medical needs. The organization emphasizes research and development, leveraging cutting-edge science and technology to enhance patient care. Astellas Pharma Europe B.V. adheres to the highest ethical standards in its clinical trials, ensuring safety, efficacy, and regulatory compliance while fostering collaboration with healthcare professionals and stakeholders across the region.

Locations

Mobile, Alabama, United States

Chandler, Arizona, United States

Phoenix, Arizona, United States

Anaheim, California, United States

Cerritos, California, United States

Glendora, California, United States

Hawaiian Gardens, California, United States

Los Angeles, California, United States

Palo Alto, California, United States

Paramount, California, United States

Sacramento, California, United States

San Diego, California, United States

Tarzana, California, United States

Valley Village, California, United States

Denver, Colorado, United States

Lakewood, Colorado, United States

Wheat Ridge, Colorado, United States

Danbury, Connecticut, United States

New Britain, Connecticut, United States

New Haven, Connecticut, United States

Waterbury, Connecticut, United States

Bradenton, Florida, United States

Hialeah, Florida, United States

Homestead, Florida, United States

Jacksonville, Florida, United States

Jupiter, Florida, United States

New Port Richey, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Pembroke Pines, Florida, United States

Plantation, Florida, United States

Sarasota, Florida, United States

Tallahassee, Florida, United States

Wellington, Florida, United States

Alpharetta, Georgia, United States

Roswell, Georgia, United States

Sandy Springs, Georgia, United States

Shawnee Mission, Kansas, United States

Wichita, Kansas, United States

Lake Charles, Louisiana, United States

Metairie, Louisiana, United States

Shreveport, Louisiana, United States

Glen Burnie, Maryland, United States

Owings Mills, Maryland, United States

Boston, Massachusetts, United States

Watertown, Massachusetts, United States

Grand Rapids, Michigan, United States

Sartell, Minnesota, United States

Billings, Montana, United States

Missoula, Montana, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Englewood, New Jersey, United States

Lawrenceville, New Jersey, United States

Moorestown, New Jersey, United States

Albuquerque, New Mexico, United States

Albany, New York, United States

Brooklyn, New York, United States

Garden City, New York, United States

Kingston, New York, United States

New York, New York, United States

Newburgh, New York, United States

Poughkeepsie, New York, United States

Williamsville, New York, United States

Concord, North Carolina, United States

Raleigh, North Carolina, United States

Winston Salem, North Carolina, United States

Cleveland, Ohio, United States

Lyndhurst, Ohio, United States

Wadsworth, Ohio, United States

West Chester, Ohio, United States

Oklahoma City, Oklahoma, United States

Medford, Oregon, United States

Bala Cynwyd, Pennsylvania, United States

Lancaster, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Uniontown, Pennsylvania, United States

West Reading, Pennsylvania, United States

Charleston, South Carolina, United States

Greer, South Carolina, United States

Mount Pleasant, South Carolina, United States

Myrtle Beach, South Carolina, United States

Simpsonville, South Carolina, United States

Summerville, South Carolina, United States

Kingsport, Tennessee, United States

Austin, Texas, United States

Carrollton, Texas, United States

Corpus Christi, Texas, United States

Houston, Texas, United States

Hurst, Texas, United States

San Antonio, Texas, United States

Sandy, Utah, United States

Richmond, Virginia, United States

Virginia Beach, Virginia, United States

Burien, Washington, United States

Mountlake Terrace, Washington, United States

Seattle, Washington, United States

Walla Walla, Washington, United States

Buenos Aires, , Argentina

Ciudad Autónoma Buenos Aires, , Argentina

Rosario Provincia De Santa Fe, , Argentina

Ballarat, , Australia

Brisbane, , Australia

Broadmeadow, , Australia

Daw Park, , Australia

Footscray, , Australia

Malvern, , Australia

Nambour, , Australia

Parkville, , Australia

Perth, , Australia

Randwick, , Australia

Richmond, , Australia

Sherwood, , Australia

Sydney, , Australia

Wollongong, , Australia

Gent, , Belgium

Leuven, , Belgium

Roeselare, , Belgium

Sint Truiden, , Belgium

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Ruse, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Veliko Tarnovo, , Bulgaria

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Saint John, New Brunswick, Canada

Barrie, Ontario, Canada

Brampton, Ontario, Canada

Brantford, Ontario, Canada

Burlington, Ontario, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

Kitchener, Ontario, Canada

London, Ontario, Canada

North York, Ontario, Canada

Toronto, Ontario, Canada

Drummondville, Quebec, Canada

Granby, Quebec, Canada

Greenfield Park, Quebec, Canada

Laval, Quebec, Canada

Montreal, Quebec, Canada

Point Claire, Quebec, Canada

Sherbrooke, Quebec, Canada

St Romuald, Quebec, Canada

Quebec, , Canada

Fuzhou, Fujian, China

Beijing, , China

Changchun, , China

Changsha, , China

Chengdu, , China

Chongqing, , China

Guangzhou, , China

Lan Zhou, , China

Lanzhou, , China

Nanchang, , China

Nanjing, , China

Shanghai, , China

Suzhou, , China

Wenzhou, , China

Wuhan, , China

Wuxi, , China

Medellin, Antioquia, Colombia

Medellin, , Colombia

Brno, , Czechia

Hradec Kralove, , Czechia

Jihlava, , Czechia

Novy Jicin, , Czechia

Olomouc, , Czechia

Ostrava, , Czechia

Plzen, , Czechia

Praha 4, , Czechia

Sternberk, , Czechia

Uherske Hradiste, , Czechia

Usti Nad Labem, , Czechia

Aalborg, , Denmark

Aarhus, , Denmark

Parnu, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

Kouvola, , Finland

Oulu, , Finland

Vantaa, , Finland

Colmar Cedex, , France

Dijon, , France

Nantes Cedex 1, , France

Nimes Cedex, , France

Paris Cedex 20, , France

Paris, , France

Pierre Benite Cedex, , France

Suresnes, , France

Tours Cedex 9, , France

Bad Ems, , Germany

Bergisch Gladbach, , Germany

Bonn, , Germany

Duisburg, , Germany

Ganderkesee, , Germany

Halle (Saale), , Germany

Leipzig, , Germany

Lutherstadt Eisleben, , Germany

Munich, , Germany

Neustadt I. Sachsen, , Germany

Rostock, , Germany

Sangerhausen, , Germany

Athens, , Greece

Hong Kong, , Hong Kong

Kowloon, , Hong Kong

Shatin, , Hong Kong

Csongrád, , Hungary

Kecskemet, , Hungary

Pecs, , Hungary

Sopron, , Hungary

Szentes, , Hungary

Veszprém, , Hungary

Ancona, , Italy

Avellino, , Italy

Latina, , Italy

Milano, , Italy

Milan, , Italy

Bucheon Si, , Korea, Republic Of

Busan, , Korea, Republic Of

Cheongju Si, , Korea, Republic Of

Daegu, , Korea, Republic Of

Daejeon, , Korea, Republic Of

Gwangju, , Korea, Republic Of

Iksan Si, , Korea, Republic Of

Incheon, , Korea, Republic Of

Jeonju Si, , Korea, Republic Of

Seongnam Si, , Korea, Republic Of

Seoul, , Korea, Republic Of

Suwon Si, , Korea, Republic Of

Liepaja, , Latvia

Olaine, , Latvia

Riga, , Latvia

Kaunas, , Lithuania

Klaipeda, , Lithuania

Vilnius, , Lithuania

Georgetown, , Malaysia

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Petaling Jaya, , Malaysia

Durango, , Mexico

Guadalajara, , Mexico

Mexico City, , Mexico

Monterrey, , Mexico

Amsterdam, , Netherlands

Enschede, , Netherlands

Nijmegen, , Netherlands

Sneek, , Netherlands

Utrecht, , Netherlands

Auckland, , New Zealand

Christchurch, , New Zealand

Hamilton, , New Zealand

Nelson, , New Zealand

Tauranga, , New Zealand

Whangarei, , New Zealand

Hamar, , Norway

Lierskogen, , Norway

ålesund, , Norway

La Victoria, Lima, Peru

San Isidro, Lima, Peru

Lima, , Peru

Bacolod City, , Philippines

Davao City, , Philippines

Manila, , Philippines

Quezon City, , Philippines

Bialystok, , Poland

Chorzow, , Poland

Gdynia, , Poland

Lodz, , Poland

Lublin, , Poland

Myslowice, , Poland

Opole, , Poland

Piaseczno, , Poland

Warsaw, , Poland

Warszawa, , Poland

Wrocław, , Poland

Brasov, , Romania

Bucuresti, , Romania

Cluj Napoca, , Romania

Iasi, , Romania

Sibiu, , Romania

Timisoara, , Romania

Kazan, , Russian Federation

Penza, , Russian Federation

Saint Petersburg, , Russian Federation

St. Petersburg, , Russian Federation

Ufa, , Russian Federation

Singapore, , Singapore

Bratislava, , Slovakia

Kosice, , Slovakia

Nitra, , Slovakia

Poprad, , Slovakia

Presov, , Slovakia

Trencin, , Slovakia

Murska Sobota, , Slovenia

Novo Mesto, , Slovenia

Cape Town, , South Africa

Centurion, , South Africa

Durban, , South Africa

Meyerspark, , South Africa

Paarl, , South Africa

Roodepoort, , South Africa

Coslada, , Spain

Esplugues De Llobregat Barcelo, , Spain

Getafe (Madrid), , Spain

Madrid, , Spain

Sevilla, , Spain

Valencia, , Spain

Boras, , Sweden

Helsingborg, , Sweden

Malmö, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Vällingby, , Sweden

Taichung, , Taiwan

Tainan, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Hat Yai, , Thailand

Khon Kaen, , Thailand

Pathum Thani, , Thailand

Ratchathewi, , Thailand

Ankara, , Turkey

Bursa, , Turkey

Denizli, , Turkey

Istanbul, , Turkey

Chernigov, , Ukraine

Chernivtsi, , Ukraine

Dnipropetrovsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Uzhorod, , Ukraine

Vinnytsya, , Ukraine

Zaporizhzhya, , Ukraine

Garston, Watfort, United Kingdom

Crewe, , United Kingdom

Gillingham, , United Kingdom

Harrow, , United Kingdom

Leeds, , United Kingdom

London, , United Kingdom

Plymouth, , United Kingdom

Reading, , United Kingdom

Sheffield, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Medical Director

Study Director

Astellas Pharma Europe B.V.

Timeline

First submit

October 25, 2013

Trial launched

November 05, 2013

Trial updated

October 20, 2024

Estimated completion

Not reported

Similar Trials

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 Launched by ASTELLAS PHARMA EUROPE B.V. · Oct 25, 2013

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
Launched by ASTELLAS PHARMA EUROPE B.V. · Oct 25, 2013