A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT ID: NCT00662909
Last Updated: 2024-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2149 participants
INTERVENTIONAL
2008-03-28
2009-04-22
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 placebo tablets orally once a day for 12 weeks
Placebo
Oral
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
Mirabegron
Oral
Mirabegron 100 mg
Participants received mirabegron 100 m tablets, orally once a day for 12 weeks
Mirabegron
Oral
Interventions
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Mirabegron
Oral
Placebo
Oral
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 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 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 YM178, other beta-adrenoreceptor (ß-AR) agonists, or any of the other inactive ingredients
* Patient has been treated with any investigational drug or device within 30 days
* 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 transferase (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 Global Development
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
Burbank, California, United States
Carmichael, California, United States
Fresno, California, United States
La Mesa, California, United States
Los Angeles, 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
San Francisco, 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
Celebration, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Fort Myers, 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
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Decatur, 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
Shreveport, Louisiana, United States
Greenbelt, Maryland, United States
Springfield, Massachusetts, 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
West Orange, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Endwell, New York, United States
Garden City, New York, United States
Kingston, 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
Bala-Cynwyd, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Reading, 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
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Mountlake Terrace, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Surrey, British Columbia, Canada
Victoria, British Columbia, Canada
Saint Johns, New Brunswick, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Kitchener, Ontario, Canada
Newmarket, Ontario, Canada
North Bay, Ontario, Canada
Oshawa, Ontario, Canada
Owen Sound, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Granby, Quebec, Canada
Pointe-Claire, Quebec, Canada
Countries
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References
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Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2013 Apr;189(4):1388-95. doi: 10.1016/j.juro.2012.10.017. Epub 2012 Oct 16.
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.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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178-CL-047
Identifier Type: -
Identifier Source: org_study_id
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