Clareo Health | Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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 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)
