A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
CAPRICORN
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects With Symptoms of Overactive Bladder
2 other identifiers
interventional
2,030
11 countries
151
Brief Summary
The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2009
Shorter than P25 for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2009
CompletedFirst Submitted
Initial submission to the registry
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2010
CompletedResults Posted
Study results publicly available
October 17, 2012
CompletedNovember 21, 2024
October 1, 2024
12 months
June 1, 2009
July 17, 2012
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Baseline and Week 12
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Baseline and Week 12
Secondary Outcomes (37)
Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition
Baseline and Week 12
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Week 4
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
Baseline and Week 4
Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency
Baseline and Week 12
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Baseline and Week 12
- +32 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants received matching mirabegron placebo tablets orally once a day for 12 weeks.
Mirabegron 25 mg
EXPERIMENTALParticipants received mirabegron 25 mg tablets orally once a day for 12 weeks.
Mirabegron 50 mg
EXPERIMENTALParticipants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Patient is willing and able to complete the micturition diary and questionnaires correctly
- 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
You may not qualify if:
- Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (151)
Unknown Facility
Homewood, Alabama, 35209, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Chandler, Arizona, 85224, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85741, United States
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Little Rock, Arkansas, 72204, United States
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Atherton, California, 94027, United States
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Buena Park, California, 90620, United States
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Fresno, California, 93720, United States
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La Mesa, California, 91942, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92660, United States
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San Bernardino, California, 92404, United States
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San Diego, California, 92108, United States
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Tarzana, California, 91356, United States
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Torrance, California, 90505, United States
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Denver, Colorado, 80211, United States
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New Britain, Connecticut, 06052, United States
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Waterbury, Connecticut, 06708, United States
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Aventura, Florida, 33180, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33761, United States
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Lauderdale Lakes, Florida, 33319, United States
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Miami, Florida, 33136, United States
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Pembroke Pines, Florida, 33024, United States
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Pembroke Pines, Florida, 33027, United States
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Sarasota, Florida, 34237, United States
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St. Petersburg, Florida, 33709, United States
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Tallahassee, Florida, 32308, United States
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Wellington, Florida, 33414, United States
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West Palm Beach, Florida, 33407, United States
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Alpharetta, Georgia, 30005, United States
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Roswell, Georgia, 30076, United States
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Melrose Park, Illinois, 60160, United States
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Fort Wayne, Indiana, 46825, United States
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Jeffersonville, Indiana, 47130, United States
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West Des Moines, Iowa, 50266, United States
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Overland Park, Kansas, 66211, United States
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Wichita, Kansas, 67207, United States
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Louisville, Kentucky, 40291, United States
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Madisonville, Kentucky, 42431, United States
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Shreveport, Louisiana, 71106, United States
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Springfield, Massachusetts, 01103, United States
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Watertown, Massachusetts, 02472, United States
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Billings, Montana, 59102, United States
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Lincoln, Nebraska, 68516, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89148, United States
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Lawrenceville, New Jersey, 08648, United States
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Albuquerque, New Mexico, 87108, United States
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Albuquerque, New Mexico, 87109, United States
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Binghamton, New York, 13901, United States
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Garden City, New York, 11530, United States
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Kingston, New York, 12401, United States
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New York, New York, 10016, United States
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Charlotte, North Carolina, 28209, United States
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Hickory, North Carolina, 28601, United States
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Raleigh, North Carolina, 27509, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45212, United States
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Cleveland, Ohio, 44122, United States
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Columbus, Ohio, 43220, United States
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Lyndhurst, Ohio, 44124, United States
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Wadsworth, Ohio, 44281, United States
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Bethany, Oklahoma, 73008, United States
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Edmond, Oklahoma, 73034, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Philadelphia, Pennsylvania, 19114, United States
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West Reading, Pennsylvania, 19605, United States
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Warwick, Rhode Island, 02886, United States
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Greer, South Carolina, 29650, United States
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Simpsonville, South Carolina, 29681, United States
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Arlington, Texas, 76017, United States
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Corpus Christi, Texas, 78414, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77024, United States
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Salt Lake City, Utah, 84107, United States
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Virginia Beach, Virginia, 23454, United States
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Mountlake Terrace, Washington, 98043, United States
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Seattle, Washington, 98166, United States
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Spokane, Washington, 99204, United States
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Vancouver, British Columbia, V5Z 1M9, Canada
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Victoria, British Columbia, V8T 5G1, Canada
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Winnipeg, Manitoba, R3C 0N2, Canada
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Bathurst, New Brunswick, E2A 4Z9, Canada
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Saint John, New Brunswick, E2L 3J8, Canada
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Barrie, Ontario, L4M 7G1, Canada
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Brampton, Ontario, L6T 4S5, Canada
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Brantford, Ontario, N3R 4N3, Canada
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Kitchener, Ontario, N2N 2B9, Canada
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North Bay, Ontario, P1B 7K8, Canada
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Thunder Bay, Ontario, P7E 6E7, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M6A 3B5, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Olomouc, 779 00, Czechia
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Ostrava, 735 81, Czechia
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Prague, 128 51, Czechia
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Prague, 140 00, Czechia
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Prague, 180 81, Czechia
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Aalborg, DK-9100, Denmark
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Aarhus N, DK-8200, Denmark
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Frederiksberg, DK-2000, Denmark
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Holstebro, DK-7500, Denmark
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Helsinki, FIN-00029, Finland
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Oulu, FIN-90220, Finland
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Tampere, FIN-33521, Finland
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Bad Ems, 56130, Germany
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Eisleben Lutherstadt, 06295, Germany
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Frankfurt, 65933, Germany
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Hagenow, 19230, Germany
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Halle, 06132, Germany
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Henningsdorf, 16761, Germany
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Hettstedt, 06333, Germany
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Koblenz, 56068, Germany
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Leipzig, 04109, Germany
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Neunkirchen, 66538, Germany
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Neustadt in Sachsen, 01844, Germany
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Radebeul, 01445, Germany
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Sangerhausen, 06526, Germany
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Budapest, 1115, Hungary
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Budapest, 1204, Hungary
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Körmend, 9900, Hungary
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Nyíregyháza, 4400, Hungary
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Sopron, 9400, Hungary
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Szekszárd, 7100, Hungary
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Szentes, 6600, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Bergen, NO-5053, Norway
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Hamar, NO-2317, Norway
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Tønsberg, NO-3116, Norway
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Martin, 036 59, Slovakia
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Trenčín, 911 01, Slovakia
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Žilina, 012 07, Slovakia
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Barcelona, 8036, Spain
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Coslada, 28822, Spain
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Getafe Madrid, 28905, Spain
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Gran Canaria, 38320, Spain
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Madrid, 28031, Spain
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Madrid, 28041, Spain
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Vic, 8500, Spain
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Gothenburg, SE-40014, Sweden
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Huddinge, SE-14186, Sweden
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Jönköping, SE-55466, Sweden
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Karlshamn, SE-37435, Sweden
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Malmo, SE-21744, Sweden
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Stockholm, SE-17176, Sweden
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Stockholm, SE-18288, Sweden
Related Publications (2)
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.
PMID: 24246044DERIVEDHerschorn 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.
PMID: 23769122DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Director, Global Medical Sciences
- Organization
- Astellas Pharma Global Development, Europe
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2009
First Posted
June 3, 2009
Study Start
April 28, 2009
Primary Completion
April 27, 2010
Study Completion
April 27, 2010
Last Updated
November 21, 2024
Results First Posted
October 17, 2012
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.