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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00454740 |
To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder, Overactive |
Drug: solifenacin succinate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US |
Enrollment: | 441 |
Study Start Date: | June 2004 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: solifenacin succinate
Oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr. Manager, Clinical Trial Registry ) |
Study ID Numbers: | 905-UC-006 |
Study First Received: | March 29, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00454740 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Urinary Bladder, Overactive Urgency VESIcare® Solifenacin succinate |
Muscarinic Antagonists Signs and Symptoms Urinary Bladder, Overactive Neurotransmitter Agents Cystocele Cholinergic Antagonists |
Urologic Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Urinary Bladder Diseases Cholinergic Agents Tolterodine |
Urinary Bladder, Overactive Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Urinary Bladder Diseases Physiological Effects of Drugs Cholinergic Agents |
Pharmacologic Actions Muscarinic Antagonists Urological Manifestations Signs and Symptoms Urologic Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate |