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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00463541 |
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).
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 Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial |
Enrollment: | 2225 |
Study Start Date: | June 2004 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: solifenacin succinate
oral
|
Study included a 24 week extension that did not occur due to FDA approval of the product.
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 Trials Registry ) |
Study ID Numbers: | 905-UC-007 |
Study First Received: | April 19, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00463541 |
Health Authority: | United States: Food and Drug Administration |
Urinary Bladder, Overactive Urgency VESIcare® Solifenacin succinate |
Signs and Symptoms Urinary Bladder, Overactive Cystocele |
Urologic Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Urinary Bladder Diseases |
Muscarinic Antagonists Urological Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Cholinergic Antagonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |