Official Title: “A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multi-Center Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder”

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: YM178
  • Oral
• Drug: Tolterodine 4 mg
  • Oral
• Drug: Placebo
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • low dose
• Experimental: 2
  • higher dose
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• Change from baseline to end of treatment in mean number of micturitions/24 h.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline to end of treatment in mean number of incontinence episodes/24 h.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in mean volume voided per micturition
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline in mean number of urgency incontinence episodes/24 h.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline in mean number of urgency episodes (grade 3 and/or 4) /24 h.
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Subject is willing and able to complete the micturition diary and questionnaires correctly
• Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
• Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
• Subject 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:

• Subject 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
• Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
• Subject has an indwelling catheter or practices intermittent self-catheterization
• Subject has diabetic neuropathy
• Subject 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
• Subject receives non-drug treatment including electro-stimulation therapy
• Subject has severe hypertension
• Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other inactive ingredients
• Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
• Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
• Subject has serum creatinine >150 umol/L, AST and/or ALT > 2x upper limit of normal range (ULN), or γ-GT > 3x ULN
• Subject has a clinically significant abnormal ECG

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Central Contact Study Director Astellas Pharma Europe BV  

Information obtained from ClinicalTrials.gov on March 16, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689104

Study ID Number: 178-CL-046

ClinicalTrials.gov Identifier: NCT00689104

Health Authority: United States: Food and Drug Administration