A Study of YM178 in Subjects With Symptoms of Overactive Bladder

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.

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

Details

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

Criteria

Inclusion Criteria:

• Subjects with symptoms of overactive bladder for at least 12 weeks before the study

• Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself

• Subject with an average frequency of micturition of 8 or more times per 24-hour period

• Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period

• Subject having provided written informed consent by him/herself

Exclusion Criteria:

• Subject having stress urinary incontinence as a predominant symptom

• Subject with transient symptoms suspected for overactive bladder

• Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection

• Subject complicated with bladder tumor/prostatic tumor or with the historical condition

• Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease

• Subject with indwelling catheter or practicing intermittent self-catheterization

• Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia

• Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study

• Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)

• Subject with a pulse rate >= 110bpm or <50 bpm