NCT00463541

Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,225 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Study included a 24 week extension that did not occur due to FDA approval of the product.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	solifenacin succinate	oral

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2007-04-20
• Last updated: 2014-09-18

Locations

198 sites across 1 country: United States