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

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

The study is intended to test the safety, tolerability, efficacy of two doses of long term treatment of YM178 in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

Patients who completed 178-CL-046 or 178-CL-047 or new patients could be enrolled in this study if eligible.

Intervention(s) in this Clinical Trial

• Drug: YM178
  • Oral
• Drug: Tolterodine 4 ng
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1: low dose
• Experimental: 2: higher dose
• Active Comparator: 3. Tolterodine

Primary Measures

• Assess incidence and severity of treatment emerged adverse events
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• Change from baseline in mean number of micturitions/24h.
  • Time Frame: 12 Months
    Safety Issue?: No
• Change from baseline in mean number of incontinence episodes/24 h
  • Time Frame: 12 Months
    Safety Issue?: No
• Change from baseline in mean volume voided per micturition.
  • 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 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 for all clinical studies except 178-CL-046)
• 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 Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Central Contact Study Director Astellas Pharma Europe BV  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688688

Study ID Number: 178-CL-049

ClinicalTrials.gov Identifier: NCT00688688

Health Authority: United States: Food and Drug Administration