Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT ID: NCT00688688
Last Updated: 2024-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2792 participants
INTERVENTIONAL
2008-04-25
2010-05-06
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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Mirabegron 50 mg
Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
Mirabegron
Tablets
Placebo to Tolterodine
Matching tolterodine placebo capsules.
Mirabegron 100 mg
Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
Mirabegron
Tablets
Placebo to Tolterodine
Matching tolterodine placebo capsules.
Tolterodine ER 4 mg
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
Tolterodine
Extended release capsules
Placebo to Mirabegron
Matching mirabegron placebo tablets.
Interventions
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Mirabegron
Tablets
Tolterodine
Extended release capsules
Placebo to Mirabegron
Matching mirabegron placebo tablets.
Placebo to Tolterodine
Matching tolterodine placebo capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has symptoms of overactive bladder for ≥ 3 months
* Patient experiences 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 has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient has evidence of a symptomatic 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 a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
* Patient has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046)
* Patient had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Patient has serum creatinine \>150 umol/L, aspartate aminotransferase (AST) and/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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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
Montgomery, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Atherton, California, United States
Beverly Hills, California, United States
Buena Park, California, United States
Fresno, California, United States
La Mesa, California, United States
Mission Hills, California, United States
Newport Beach, California, United States
Orange, California, United States
Sacramento, California, United States
San Bernardino, California, United States
San Diego, California, United States
San Diego, California, United States
Tarzana, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
New Britain, Connecticut, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Coeur d'Alene, Idaho, United States
Idaho Falls, Idaho, United States
Melrose Park, Illinois, United States
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
Newburgh, Indiana, United States
Des Moines, Iowa, United States
Wichita, Kansas, United States
Greenbelt, Maryland, United States
Watertown, Massachusetts, United States
North Kansas City, Missouri, United States
Billings, Montana, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
West Orange, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Albany, New York, United States
Endwell, New York, United States
Garden City, New York, United States
Kingston, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, 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
Edmond, Oklahoma, United States
Bala-Cynwyd, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Reading, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Arlington, Texas, United States
Austin, 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
Tacoma, Washington, United States
Woolloongabba, , Australia
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Minsk, , Belarus
Minsk, , Belarus
Antwerp, , Belgium
Antwerp, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leper, , Belgium
Leuven, , Belgium
Liège, , Belgium
Sint-Truiden, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Surrey, British Columbia, Canada
Victoria, British Columbia, Canada
Victoria, British Columbia, Canada
Saint John, New Brunswick, Canada
Dartmouth, Nova Scotia, Canada
Kentville, Nova Scotia, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Kitchener, Ontario, Canada
Markham, Ontario, Canada
Newmarket, Ontario, Canada
North Bay, Ontario, Canada
Oshawa, Ontario, Canada
Saint Denis, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Granby, Quebec, Canada
Montreal, Quebec, Canada
Point Claire, Quebec, Canada
Montreal, , Canada
Brno, , Czechia
Mělník, , Czechia
Olomouc, , Czechia
Ostrava-Poruba, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Štětí, , Czechia
Ústí nad Labem, , Czechia
Aalborg, , Denmark
Aarhus, , Denmark
Glostrup Municipality, , Denmark
Roskilde, , Denmark
Helsinki, , Finland
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Paris, Cedex 10, France
Colmar, , France
Marseille, , France
Mulhouse, , France
Nîmes, , France
Orléans, , France
Paris-Cedex12, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Toulouse, , France
Aichach, , Germany
Bad Ems, , Germany
Bautzen, , Germany
Berlin, , Germany
Duisburg, , Germany
Eisleben Lutherstadt, , Germany
Frankfurt, , Germany
Ganderkesee, , Germany
Hagenow, , Germany
Halle, , Germany
Hamburg, , Germany
Henningsdorf, , Germany
Hettstedt, , Germany
Kiel, , Germany
Koblenz, , Germany
Leipzig, , Germany
Muenchen-Bogenhausen, , Germany
Munich, , Germany
Neustadt in Sachsen, , Germany
Oranienburg, , Germany
Radebeul, , Germany
Sangerhausen, , Germany
Trier, , Germany
Uetersen, , Germany
Budapest, , Hungary
Budapest, , Hungary
Nyíregyháza, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Tatabánya, , Hungary
Reykjavik, , Iceland
Dublin, , Ireland
Mullingar, , Ireland
Bari, , Italy
Catanzaro, , Italy
Genoa, , Italy
Latina, , Italy
Milan, , Italy
Modena, , Italy
Naples, , Italy
Perugia, , Italy
Treviglio, , Italy
Varese, , Italy
Liepāja, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Eindhoven, , Netherlands
Enschede, , Netherlands
Leiden, , Netherlands
Nijmegen, , Netherlands
Sneek, , Netherlands
Tilburg, , Netherlands
Winterswijk, , Netherlands
Bergen, , Norway
Drammen, , Norway
Hamar, , Norway
Oslo, , Norway
Tønsberg, , Norway
Bialystok, , Poland
Lodz, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Amadora, , Portugal
Porto, , Portugal
Tomar, , Portugal
Bucharest, , Romania
Bucharest, , Romania
Lasi, , Romania
Oradea, , Romania
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Martin, , Slovakia
Poprad, , Slovakia
Skalica, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
Hatfield, , South Africa
Lyttelton, , South Africa
Paarl, , South Africa
Pietermaritzburg, , South Africa
Roodepoort, , South Africa
Barcelona, , Spain
Barcelona, , Spain
Bilbao, , Spain
Getafe, , Spain
Madrid, , Spain
Madrid, , Spain
Mataró, , Spain
Miranda de Ebro, , Spain
Seville, , Spain
Toledo, , Spain
Valencia, , Spain
Huddinge, , Sweden
Örebro, , Sweden
Skövde, , Sweden
Sonkoping, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Frauenfeld, , Switzerland
Lucerne, , Switzerland
Kiev, , Ukraine
Kiev, , Ukraine
Bristol, , United Kingdom
Chorley, , United Kingdom
Croydon, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Northwood, , United Kingdom
Reading, , United Kingdom
Reading, , United Kingdom
Sheffield, , United Kingdom
Swansea, , United Kingdom
Countries
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References
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Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2007-001452-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
178-CL-049
Identifier Type: -
Identifier Source: org_study_id
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