A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: tolterodine ER; Drug: YM178; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043666

178-CL-090

Details and patient eligibility

About

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

Enrollment: 1,126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,126 participants in 3 patient groups, including a placebo group

YM178 group

Experimental group

Description:

oral

Treatment:

Drug: YM178

placebo group

Placebo Comparator group

Description:

oral

Treatment:

Drug: Placebo

tolterodine ER group

Experimental group

Description:

oral

Treatment:

Drug: tolterodine ER