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

• Status: Completed
• Trial end date: 2010-05-06
• Target enrollment: 0
• Participant gender: All

Summary

The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron; Tolterodine Tartrate

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)