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

• Status: Completed
• Trial end date: 2009-04-22
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron

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 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)