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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00527033 |
Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder, Overactive |
Drug: YM178 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study in Patients With Symptomatic Overactive Bladder |
Enrollment: | 842 |
Study Start Date: | September 2007 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: YM178
Oral
|
2: Experimental |
Drug: YM178
Oral
|
3: Experimental |
Drug: YM178
Oral
|
4: Placebo Comparator |
Drug: Placebo
Oral
|
To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Astellas Pharma, Inc. ( Director ) |
Study ID Numbers: | 178-CL-045 |
Study First Received: | September 6, 2007 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00527033 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
YM178 Urinary Bladder, Overactive |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases Urinary Bladder Diseases |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases Urinary Bladder Diseases |