A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

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

Details

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

Criteria

Inclusion Criteria:

• Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period

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

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

• Written informed consent has been obtained

Exclusion Criteria:

• Patients without experience of urge incontinence before informed consent

• Patients given a clear diagnosis of stress incontinence

• Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)

• Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis

• Patients with a previous history of recurrent urinary tract infection

• Patients complicated with or with a history of bladder tumor or prostatic tumor

• Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease

• Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period

• Patients with an indwelling catheter or practicing intermittent self-catheterization

• Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia

• Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period

• Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or < 50 bpm

• Patients with polyuria exceeding 3000 mL in mean daily urine volume

• Patients meeting any of the following in the examinations

• Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee

• Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)

• Patients with a blood creatinine level ≥ 2.0 mg/dL