A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With S… (NCT00662909) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
United States2,149 participantsStarted 2008-03-28
Plain-language summary
The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is willing and able to complete the micturition diary and questionnaires correctly
* Patient has symptoms of overactive bladder for ≥ 3 months
* Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Patient 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:
* Patient 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
* Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient 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
* Patient receives non-drug treatment including electro-stimulation therapy
* Patient has severe hypertension
* Patient has a known or suspected hypersensitivity to YM178, other beta-adrenoreceptor (Ăź-AR) agonists, or any of the other inactive ingredients
* Patient has been treated with any investigational drug or device within 30 days
* Patient had an average total dai…
What they're measuring
1
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
Timeframe: Baseline and Week 12 (Final Visit)
2
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours