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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00479505 |
This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.
Condition | Intervention | Phase |
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Urinary Bladder, Overactive |
Drug: UK-369,003 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED). |
Estimated Enrollment: | 275 |
Study Start Date: | June 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Experimental
N/A
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Drug: UK-369,003
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
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Placebo: Placebo Comparator
N/A
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3711047 |
Study First Received: | May 24, 2007 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00479505 History of Changes |
Health Authority: | France: Ministry of Health |
Signs and Symptoms Urinary Bladder, Overactive Cystocele |
Urologic Diseases Urinary Bladder Diseases Erectile Dysfunction |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases Urinary Bladder Diseases |