A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Inclusion Criteria:

- 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 Criteria:

- 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)