NCT00573508

Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 768 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Detailed description

Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group. The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment. Primary efficacy will be based on OAB-q symptom bother score.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Placebo	Oral Administration
DRUG	Solifenacin Succinate	Oral Administration

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-12-14
• Last updated: 2010-10-05
• Results posted: 2010-10-05

Locations

59 sites across 1 country: United States