Status:
COMPLETED
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2009
Estimated Enrollment :
2149 Patients enrolled
Trial Details
Trial ID
NCT00662909
Start Date
March 28 2008
End Date
April 22 2009
Last Update
November 20 2024
Active Locations (125)
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1
Homewood, Alabama, United States, 35209
2
Huntsville, Alabama, United States, 35801
3
Mobile, Alabama, United States, 36608
4
Montgomery, Alabama, United States, 36117