Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist YM178 in Patients With Symptoms of Overactive Bladder - NCT00688688-33761 (Clinical Trial 223674)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy223674.aspx
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| City: |
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Clearwater |
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State:
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FL |
| Zip Code: |
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33761 |
| Conditions: |
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Urinary Bladder, Overactive |
| Purpose: |
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The study is intended to test the safety, tolerability, efficacy of two doses of long term
treatment of YM178 in patients with symptoms of overactive bladder and secondly to compare
these with active comparator.
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| Study summary: |
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Patients who completed 178-CL-046 or 178-CL-047 or new patients could be enrolled in this
study if eligible. |
| Criteria: |
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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 experiences 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 tolterodine, other
anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other inactive
ingredients
- Subject has been treated with any investigational drug or device within 30 days (90
days in the UK for all clinical studies except 178-CL-046)
- Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day
micturition diary period
- Subject has serum creatinine >150 umol/L, AST and/or ALT > 2x upper limit of normal
range (ULN), or γ-GT > 3x ULN
- Subject has a clinically significant abnormal ECG |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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October 20, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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