A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
ARIES
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder
1 other identifier
interventional
2,149
2 countries
125
Brief Summary
The study is intended to test the efficacy, safety and tolerability of two doses of 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 Mar 2008
Shorter than P25 for phase_3
125 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
March 28, 2008
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2009
CompletedResults Posted
Study results publicly available
October 17, 2012
CompletedNovember 20, 2024
October 1, 2024
1.1 years
April 17, 2008
July 11, 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 (Final Visit)
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 (29)
Change From Baseline to 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 Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Weeks 8 and 12
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
Baseline and Weeks 8 and 12
- +24 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants received matching placebo tablets orally once a day for 12 weeks
Mirabegron 50 mg
EXPERIMENTALParticipants received mirabegron 50 mg tablets orally once a day for 12 weeks
Mirabegron 100 mg
EXPERIMENTALParticipants received mirabegron 100 m 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 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 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (125)
Unknown Facility
Homewood, Alabama, 35209, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Montgomery, Alabama, 36117, United States
Unknown Facility
Anchorage, Alaska, 99508, United States
Unknown Facility
Phoenix, Arizona, 85051, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Tucson, Arizona, 85741, United States
Unknown Facility
Atherton, California, 94027, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Buena Park, California, 90620, United States
Unknown Facility
Burbank, California, 91506, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Los Angeles, California, 90017, United States
Unknown Facility
Mission Hills, California, 91345, United States
Unknown Facility
Newport Beach, California, 92660, United States
Unknown Facility
Orange, California, 92869, United States
Unknown Facility
Sacramento, California, 95816, United States
Unknown Facility
San Bernardino, California, 92404, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Francisco, California, 94102, United States
Unknown Facility
Tarzana, California, 91356, United States
Unknown Facility
Torrance, California, 90505, United States
Unknown Facility
Aurora, Colorado, 80012, United States
Unknown Facility
Denver, Colorado, 80211, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Englewood, Colorado, 80112, United States
Unknown Facility
New Britain, Connecticut, 06052, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Aventura, Florida, 33180, United States
Unknown Facility
Celebration, Florida, 34747, United States
Unknown Facility
Clearwater, Florida, 33756, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Fort Myers, Florida, 33916, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
Pembroke Pines, Florida, 33027, United States
Unknown Facility
Sarasota, Florida, 34237, United States
Unknown Facility
Tallahassee, Florida, 32308, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
Alpharetta, Georgia, 30005, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Decatur, Georgia, 30034, United States
Unknown Facility
Roswell, Georgia, 30076, United States
Unknown Facility
Coeur d'Alene, Idaho, 83814, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Melrose Park, Illinois, 60160, United States
Unknown Facility
Fort Wayne, Indiana, 46825, United States
Unknown Facility
Jeffersonville, Indiana, 47130, United States
Unknown Facility
Newburgh, Indiana, 47630, United States
Unknown Facility
Des Moines, Iowa, 50309, United States
Unknown Facility
Wichita, Kansas, 57207, United States
Unknown Facility
Shreveport, Louisiana, 71106, United States
Unknown Facility
Greenbelt, Maryland, 20770, United States
Unknown Facility
Springfield, Massachusetts, 01103, United States
Unknown Facility
Watertown, Massachusetts, 02472, United States
Unknown Facility
North Kansas City, Missouri, 64116, United States
Unknown Facility
Billings, Montana, 59102, United States
Unknown Facility
Lincoln, Nebraska, 68516, United States
Unknown Facility
Omaha, Nebraska, 68114, United States
Unknown Facility
Las Vegas, Nevada, 89148, United States
Unknown Facility
West Orange, New Jersey, 07052, United States
Unknown Facility
Albuquerque, New Mexico, 87109, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Endwell, New York, 13760, United States
Unknown Facility
Garden City, New York, 11530, United States
Unknown Facility
Kingston, New York, 12401, United States
Unknown Facility
Poughkeepsie, New York, 12601, United States
Unknown Facility
Cary, North Carolina, 27518, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Concord, North Carolina, 28025, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Fargo, North Dakota, 58104, United States
Unknown Facility
Cincinnati, Ohio, 45212, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Columbus, Ohio, 43214, United States
Unknown Facility
Lyndhurst, Ohio, 44124, United States
Unknown Facility
Wadsworth, Ohio, 44281, United States
Unknown Facility
Bethany, Oklahoma, 73008, United States
Unknown Facility
Edmond, Oklahoma, 73034, United States
Unknown Facility
Bala-Cynwyd, Pennsylvania, 19004, United States
Unknown Facility
Lancaster, Pennsylvania, 17604, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Reading, Pennsylvania, 19611, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Greer, South Carolina, 29650, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Simpsonville, South Carolina, 29681, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
Arlington, Texas, 76017, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Unknown Facility
Mountlake Terrace, Washington, 98043, United States
Unknown Facility
Seattle, Washington, 98166, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Surrey, British Columbia, V3V 1N1, Canada
Unknown Facility
Victoria, British Columbia, V8T 5G1, Canada
Unknown Facility
Saint Johns, New Brunswick, E2L 3J8, Canada
Unknown Facility
Barrie, Ontario, L4M 7G1, Canada
Unknown Facility
Brampton, Ontario, L6T 4S5, Canada
Unknown Facility
Kitchener, Ontario, N2N 2B9, Canada
Unknown Facility
Newmarket, Ontario, L3X 1W1, Canada
Unknown Facility
North Bay, Ontario, P1B 7K8, Canada
Unknown Facility
Oshawa, Ontario, L1H 1B9, Canada
Unknown Facility
Owen Sound, Ontario, M4K 2J1, Canada
Unknown Facility
Thunder Bay, Ontario, P7E 6E7, Canada
Unknown Facility
Toronto, Ontario, M4N 3M5, Canada
Unknown Facility
Toronto, Ontario, M5T 2S8, Canada
Unknown Facility
Toronto, Ontario, M6S 4W4, Canada
Unknown Facility
Granby, Quebec, J2G 8Z9, Canada
Unknown Facility
Pointe-Claire, Quebec, H9R 4S3, Canada
Related Publications (2)
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.
PMID: 23079373BACKGROUNDDesroziers 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: 24246044DERIVED
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, Medical Sciences
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Global Development
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
April 17, 2008
First Posted
April 21, 2008
Study Start
March 28, 2008
Primary Completion
April 22, 2009
Study Completion
April 22, 2009
Last Updated
November 20, 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/.