A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT ID: NCT00912964
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2030 participants
INTERVENTIONAL
2009-04-28
2010-04-27
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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Placebo
Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
Placebo
Matching mirabegron placebo tablets.
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
Mirabegron
Mirabegron tablets
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Mirabegron
Mirabegron tablets
Interventions
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Mirabegron
Mirabegron tablets
Placebo
Matching mirabegron placebo tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has symptoms of overactive bladder (OAB) for ≥ 3 months
* Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period
Exclusion Criteria
* Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Patient is using medications intended to treat OAB
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient has evidence of urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Patient receives non-drug treatment including electro-stimulation therapy
* Patient has severe hypertension
* Patient has participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
* Patient had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Patient has serum creatinine of \>150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (γ-GT) \> 3x ULN
* Patient has a clinically significant abnormal electrocardiogram (ECG)
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Homewood, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Atherton, California, United States
Buena Park, California, United States
Fresno, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
San Bernardino, California, United States
San Diego, California, United States
Tarzana, California, United States
Torrance, California, United States
Denver, Colorado, United States
New Britain, Connecticut, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Wellington, Florida, United States
West Palm Beach, Florida, United States
Alpharetta, Georgia, United States
Roswell, Georgia, United States
Melrose Park, Illinois, United States
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
West Des Moines, Iowa, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Shreveport, Louisiana, United States
Springfield, Massachusetts, United States
Watertown, Massachusetts, United States
Billings, Montana, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Garden City, New York, United States
Kingston, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Lyndhurst, Ohio, United States
Wadsworth, Ohio, United States
Bethany, Oklahoma, United States
Edmond, Oklahoma, United States
Bala-Cynwyd, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Simpsonville, South Carolina, United States
Arlington, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Virginia Beach, Virginia, United States
Mountlake Terrace, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Bathurst, New Brunswick, Canada
Saint John, New Brunswick, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Brantford, Ontario, Canada
Kitchener, Ontario, Canada
North Bay, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Granby, Quebec, Canada
Sherbrooke, Quebec, Canada
Olomouc, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Aarhus N, , Denmark
Frederiksberg, , Denmark
Holstebro, , Denmark
Helsinki, , Finland
Oulu, , Finland
Tampere, , Finland
Bad Ems, , Germany
Eisleben Lutherstadt, , Germany
Frankfurt, , Germany
Hagenow, , Germany
Halle, , Germany
Henningsdorf, , Germany
Hettstedt, , Germany
Koblenz, , Germany
Leipzig, , Germany
Neunkirchen, , Germany
Neustadt in Sachsen, , Germany
Radebeul, , Germany
Sangerhausen, , Germany
Budapest, , Hungary
Budapest, , Hungary
Körmend, , Hungary
Nyíregyháza, , Hungary
Sopron, , Hungary
Szekszárd, , Hungary
Szentes, , Hungary
Székesfehérvár, , Hungary
Tatabánya, , Hungary
Bergen, , Norway
Hamar, , Norway
Tønsberg, , Norway
Martin, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
Barcelona, , Spain
Coslada, , Spain
Getafe Madrid, , Spain
Gran Canaria, , Spain
Madrid, , Spain
Madrid, , Spain
Vic, , Spain
Gothenburg, , Sweden
Huddinge, , Sweden
Jönköping, , Sweden
Karlshamn, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Countries
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References
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Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.
Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2008-007087-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
178-CL-074
Identifier Type: -
Identifier Source: org_study_id
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