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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00662909 |
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
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder, Overactive |
Drug: YM178 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 1620 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Low dose
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Drug: YM178
Oral
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2: Experimental
Higher dose
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Drug: YM178
Oral
|
3: Placebo Comparator |
Drug: Placebo
Oral
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Astellas Pharma US Medical Information | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 178-CL-047 |
Study First Received: | April 17, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00662909 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Overactive bladder (OAB) Frequency Micturition Urgency |
Urinary incontinence Urinary urge incontinence YM178 |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases |
Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge |
Urological Manifestations |