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
Launched by ASTELLAS PHARMA EUROPE B.V. · Jan 23, 2014
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Saint Petersburg, , Russian Federation
Mobile, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Hawaiian Gardens, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Paramount, California, United States
San Diego, California, United States
Tarzana, California, United States
Valley Village, California, United States
Wheat Ridge, Colorado, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Jupiter, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Alpharetta, Georgia, United States
Roswell, Georgia, United States
Sandy Springs, Georgia, United States
Wichita, Kansas, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
Hanover, Maryland, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Billings, Montana, United States
Missoula, Montana, United States
Lincoln, Nebraska, United States
Englewood, New Jersey, United States
Lawrenceville, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, 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
Concord, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Cleveland, Ohio, United States
Wadsworth, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Bala Cynwyd, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Uniontown, Pennsylvania, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Mount Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Summerville, South Carolina, United States
Kingsport, Tennessee, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, 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
Broadmeadow, New South Wales, Australia
Randwick, New South Wales, Australia
Randwick, New South Wales, Australia
Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Nambour, Queensland, Australia
Sherwood, Queensland, Australia
Daw Park, South Australia, Australia
Footscray, Victoria, Australia
Parkville, Victoria, Australia
Perth, Western Australia, Australia
Gent, , Belgium
Roeselare, , Belgium
Sint Truiden, , Belgium
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Saint John, New Brunswick, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Brantford, Ontario, Canada
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Drummondville, Quebec, Canada
Levis, Quebec, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Montreal, , Canada
Quebec, , Canada
Brno, , Czechia
Hradec Kralove, , Czechia
Hradec Kralove, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Plzen, , Czechia
Praha 2, , Czechia
Praha 4, , Czechia
Sternberk, , Czechia
Uherske Hradiste, , Czechia
Usti Nad Labem, , Czechia
Aarhus, , Denmark
Parnu, , Estonia
Kouvola, , Finland
Munich, Bavaria, Germany
Bergisch Gladbach, Northwest, Germany
Duisburg, Nrw, Germany
Lutherstadt Eisleben, Sachsen Anhalt, Germany
Leipzig, Sachsen, Germany
Bad Ems, , Germany
Duisburg, , Germany
Ganderkesee, , Germany
Halle (Saale), , Germany
Neustadt I. Sachsen, , Germany
Rostock, , Germany
Sangerhausen, , Germany
Kecskemet, Bacs Kiskun Megye, Hungary
Pecs, Baranya Megye, Hungary
Csongrad, Csongrad Megye, Hungary
Szentes, Csongrad Megye, Hungary
Sopron, Gyor Moson Sopron, Hungary
Veszprem, Veszprem Megye, Hungary
Ancona, , Italy
Avellino, , Italy
Latina, , Italy
Milano, , Italy
Suwon Si, Gyeonggi Do, Korea, Republic Of
Bucheon Si, Gyunggido, Korea, Republic Of
Seoul, Gyunggido, Korea, Republic Of
Jeonju Si, Jeollabuk Do South Korea, Korea, Republic Of
Busan, , Korea, Republic Of
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Daegu, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Liepaja, , Latvia
Olaine, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipeda, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Petaling Jaya, , Malaysia
Mexico City, Df, Mexico
Enschede, Nl, Netherlands
Amsterdam, , Netherlands
Nijmegen, , Netherlands
Sneek, , Netherlands
Christchurch, Canterbury, New Zealand
Nelson, , New Zealand
Tauranga, , New Zealand
Whangarei, , New Zealand
Alesund, , Norway
Hamar, , Norway
Lierskogen, , Norway
Bialystok, , Poland
Chorzow, , Poland
Gdynia, , Poland
Lodz, , Poland
Lublin, , Poland
Myslowice, , Poland
Opole, , Poland
Piaseczno, , Poland
Warsaw, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wrocław, , Poland
Cluj Napoca, Cluj, Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Sibiu, , Romania
Timisoara, , Romania
Kazan, , Russian Federation
Penza, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Ufa, , Russian Federation
Singapore, , Singapore
Singapore, , Singapore
Bratislava, , Slovakia
Kosice, , Slovakia
Kosice, , Slovakia
Nitra, , Slovakia
Poprad, , Slovakia
Prešov, , Slovakia
Trencin, , Slovakia
Trencin, , Slovakia
Murska Sobota, , Slovenia
Centurion, Gauteng, South Africa
Roodepoort, Gauteng, South Africa
Durban, Kwa Zulu Natal, South Africa
Meyerspark, Pretoria, South Africa
Paarl, Western Cape, South Africa
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Boras, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Bangkok, , Thailand
Khon Kaen, , Thailand
Cherenigiv, , Ukraine
Chernivtsi, , Ukraine
Dnepropetrovsk, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Zaporizhzhya, , Ukraine
Sheffield, South Yorkshire, United Kingdom
Plymouth, , United Kingdom
Watford, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Astellas Pharma Europe B.V.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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