| April 17, 2008 |
| May 20, 2009 |
| April 2008 |
| April 2009 (final data collection date for primary outcome measure) |
- Change from baseline to end of treatment in mean number of micturitions per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline to end of treatment in mean number of incontinence episode per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00662909 on ClinicalTrials.gov Archive Site |
- Change from baseline in mean volume voided per micturition [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean number of urgency incontinence episodes per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean number of urgency episodes (grade 3 and/or 4) per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Patients With Symptoms of Overactive Bladder |
| A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder |
The study is intended to test the efficacy, safety and tolerability of two doses of YM178 against placebo to treat patients with symptoms of overactive bladder |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Urinary Bladder, Overactive |
- Drug: YM178
- Drug: Placebo
|
- Experimental: Low dose
- Experimental: Higher dose
|
| |
| |
| Completed |
| 2190 |
| April 2009 |
| April 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subject is willing and able to complete the micturition diary and questionnaires correctly
- Subject has symptoms of overactive bladder for >= 3 months
- Subject must experience frequency of micturition on average >= 8 times per 24-hour period during the 3-day micturition diary period
- Subject 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:
- Subject 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
- Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Subject has an indwelling catheter or practices intermittent self-catheterization
- Subject has diabetic neuropathy
- Subject 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
- Subject receives non-drug treatment including electro-stimulation therapy
- Subject has severe hypertension
- Subject has a known or suspected hypersensitivity to YM178, other ß-AR agonists, or any of the other inactive ingredients
- Subject has been treated with any investigational drug or device within 30 days
- Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
- Subject has serum creatinine of >150 μmol/L, or AST or ALT > 2x upper limit of normal range (ULN), or γ-GT > 3x ULN
- Subject has a clinically significant abnormal ECG
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00662909 |
| Sr Manager Clinical Trial Registry, Astellas Pharma Global Development |
| 178-CL-047 |
| Astellas Pharma Inc |
|
| Study Director: |
Use Central Contact |
Astellas Pharma Global Development |
|
|
| Astellas Pharma Inc |
| May 2009 |