Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder | NCT00688688 | Trialant

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder | NCT00688688 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 experiences 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 tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients

Patient has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046)

Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period

Patient has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/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)