Phase III study of YM178 - A randomized, double-blind, parallel group, placebo and active controlled, multi-center study in subjects with symptoms of overactive bladder

Astellas Pharma Inc0 个研究点目标入组 1,300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Ages Eligible for Study: 18 Years and older,
•Genders Eligible for Study: Both,
•Accepts Healthy Volunteers: No.
•Inclusion Criteria:
•1. Subjects with symptoms of overactive bladder for at least 12 weeks before the study
•2. Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
•3. Subject with an average frequency of micturition of 8 or more times per 24-hour period
•4. Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
•5. Subject having provided written informed consent by him/herself

•1. Subject having stress urinary incontinence as a predominant symptom
•2. Subject with transient symptoms suspected for overactive bladder
•3. Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
•4. Subject complicated with bladder tumor/prostatic tumor or with the historical condition
•5. Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
•6. Subject with indwelling catheter or practicing intermittent self-catheterization
•7. Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
•8. Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
•9. Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)
•10. Subject with a pulse rate >= 110bpm or <50 bpm

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